https://www.pureglobal.com/de/markets 2026-06-17 https://www.pureglobal.com/de/markets/argentina 2026-10-15 https://www.pureglobal.com/de/markets/australia 2026-10-15 https://www.pureglobal.com/de/markets/australia/artg-sponsor-manufacturer-evidence 2026-10-15 https://www.pureglobal.com/de/markets/bangladesh 2026-10-15 https://www.pureglobal.com/de/markets/brazil 2026-10-15 https://www.pureglobal.com/de/markets/brazil/ai-brazil-anvisa-submissions 2026-10-15 https://www.pureglobal.com/de/markets/brazil/anvisa-medical-device-classification 2026-10-15 https://www.pureglobal.com/de/markets/brazil/anvisa-medical-device-labeling 2026-10-15 https://www.pureglobal.com/de/markets/brazil/anvisa-medical-device-postmarket-surveillance 2026-10-15 https://www.pureglobal.com/de/markets/brazil/anvisa-medical-device-regulations 2026-10-15 https://www.pureglobal.com/de/markets/brazil/inmetro-anatel-medical-device-certification 2026-10-15 https://www.pureglobal.com/de/markets/canada 2026-10-15 https://www.pureglobal.com/de/markets/canada/medical-device-licence-mdl-vs-mdel 2026-10-15 https://www.pureglobal.com/de/markets/china China NMPA: Produktregistrierungswege https://www.pureglobal.com/assets/video-posters/Py5Uz9dIR02qXfIy7796D02yWaXwfVtG023CqZO2CL02gE00.jpg Ein Videoleitfaden zu NMPA-Produktklassen, Registrierungswegen, Prüffristen und Chinas GMP-Rahmenwerk für Medizinprodukte. https://stream.mux.com/Py5Uz9dIR02qXfIy7796D02yWaXwfVtG023CqZO2CL02gE00.m3u8 https://player.mux.com/Py5Uz9dIR02qXfIy7796D02yWaXwfVtG023CqZO2CL02gE00?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FPy5Uz9dIR02qXfIy7796D02yWaXwfVtG023CqZO2CL02gE00.jpg&accent-color=%232451c6 115 2026-10-16T04:59:21.203Z 2026-10-15 https://www.pureglobal.com/de/markets/colombia 2026-10-15 https://www.pureglobal.com/de/markets/colombia/invima-medical-device-classification 2026-10-15 https://www.pureglobal.com/de/markets/colombia/invima-medical-device-labeling 2026-10-15 https://www.pureglobal.com/de/markets/colombia/invima-medical-device-postmarket-compliance 2026-10-15 https://www.pureglobal.com/de/markets/colombia/invima-medical-device-regulations 2026-10-15 https://www.pureglobal.com/de/markets/costa-rica 2026-10-15 https://www.pureglobal.com/de/markets/egypt 2026-10-15 https://www.pureglobal.com/de/markets/european-union 2026-10-15 https://www.pureglobal.com/de/markets/european-union/ce-mark-notified-body-search EU-MDR: Auswahl einer Benannten Stelle https://www.pureglobal.com/assets/video-posters/hm5Pl53mUXV00dpBZdTCSQ02AnNlLWYnTs2PIbnOEbGO00.jpg Erfahren Sie, wie Sie NANDO nutzen, um Benennung und Geltungsbereich einer Benannten Stelle für Ihr Produkt unter der EU-MDR zu prüfen. https://stream.mux.com/hm5Pl53mUXV00dpBZdTCSQ02AnNlLWYnTs2PIbnOEbGO00.m3u8 https://player.mux.com/hm5Pl53mUXV00dpBZdTCSQ02AnNlLWYnTs2PIbnOEbGO00?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2Fhm5Pl53mUXV00dpBZdTCSQ02AnNlLWYnTs2PIbnOEbGO00.jpg&accent-color=%232451c6 104 2026-10-16T04:58:47.608Z 2026-10-15 https://www.pureglobal.com/de/markets/european-union/ec-european-authorized-representative EU-Bevollmächtigte: Artikel 11 https://www.pureglobal.com/assets/video-posters/8f2diZEFPEGBYwbxgEpcIL81gUNdow1kmcCTRB00WES4.jpg Erfahren Sie, wann ein EU-Bevollmächtigter nötig ist und was Artikel 11 der MDR und IVDR verlangt. https://stream.mux.com/8f2diZEFPEGBYwbxgEpcIL81gUNdow1kmcCTRB00WES4.m3u8 https://player.mux.com/8f2diZEFPEGBYwbxgEpcIL81gUNdow1kmcCTRB00WES4?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F8f2diZEFPEGBYwbxgEpcIL81gUNdow1kmcCTRB00WES4.jpg&accent-color=%232451c6 100 2026-10-16T04:59:45.925Z 2026-10-15 https://www.pureglobal.com/de/markets/european-union/eu-ivdr-consulting 2026-10-15 https://www.pureglobal.com/de/markets/european-union/eu-ivdr-consulting/ce-marking-approval-for-ivds 2026-10-15 https://www.pureglobal.com/de/markets/european-union/eu-ivdr-consulting/ivdr-classification IVDR: Klassen A–D und Übergangsfristen https://www.pureglobal.com/assets/video-posters/xFfNtUAJbK9nQD6IlZ41k13i47i2GVxwTtp2JBBYoVA.jpg Erfahren Sie mehr über IVDR-Klassifizierung, Anhang-VIII-Regeln und die im Video behandelten Übergangsfristen für Legacy-IVDs. https://stream.mux.com/xFfNtUAJbK9nQD6IlZ41k13i47i2GVxwTtp2JBBYoVA.m3u8 https://player.mux.com/xFfNtUAJbK9nQD6IlZ41k13i47i2GVxwTtp2JBBYoVA?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FxFfNtUAJbK9nQD6IlZ41k13i47i2GVxwTtp2JBBYoVA.jpg&accent-color=%232451c6 117 2026-10-16T04:59:40.284Z 2026-10-15 https://www.pureglobal.com/de/markets/european-union/eu-ivdr-consulting/ivdr-per-performance-evaluation-report 2026-10-15 https://www.pureglobal.com/de/markets/european-union/eu-ivdr-consulting/pmpf-postmarket-performance 2026-10-15 https://www.pureglobal.com/de/markets/european-union/eu-mdr-consulting 2026-10-15 https://www.pureglobal.com/de/markets/european-union/eu-mdr-consulting/eu-mdr-ce-marking-approval-for-medical-devices 2026-10-15 https://www.pureglobal.com/de/markets/european-union/eu-mdr-consulting/eu-mdr-classification-for-medical-devices EU-MDR: Klassifizierungsregeln für Medizinprodukte https://www.pureglobal.com/assets/video-posters/E67JA1rg012v0002bCwrk6gZzbkcuT8EyFB19PUTqDzJMQ.jpg Erfahren Sie, wie die 22 Regeln von Anhang VIII die EU-MDR-Klassen bestimmen und wie Sie die strengste Regel anwenden. https://stream.mux.com/E67JA1rg012v0002bCwrk6gZzbkcuT8EyFB19PUTqDzJMQ.m3u8 https://player.mux.com/E67JA1rg012v0002bCwrk6gZzbkcuT8EyFB19PUTqDzJMQ?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FE67JA1rg012v0002bCwrk6gZzbkcuT8EyFB19PUTqDzJMQ.jpg&accent-color=%232451c6 108 2026-10-16T04:59:27.006Z 2026-10-15 https://www.pureglobal.com/de/markets/european-union/eu-mdr-consulting/eu-mdr-clinical-evaluation-reports-cer-for-medical-devices EU-MDR: Klinische Bewertungsberichte https://www.pureglobal.com/assets/video-posters/teVFqOlFbuce01lKbdwr2d013lyRTQYKcsR7apvEpQMTI.jpg Eine Einführung in den klinischen Bewertungsbericht der EU-MDR, Evidenzanforderungen und die Aktualisierung des CER. https://stream.mux.com/teVFqOlFbuce01lKbdwr2d013lyRTQYKcsR7apvEpQMTI.m3u8 https://player.mux.com/teVFqOlFbuce01lKbdwr2d013lyRTQYKcsR7apvEpQMTI?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FteVFqOlFbuce01lKbdwr2d013lyRTQYKcsR7apvEpQMTI.jpg&accent-color=%232451c6 110 2026-10-16T04:59:53.863Z 2026-10-15 https://www.pureglobal.com/de/markets/european-union/eu-mdr-consulting/eu-pmcf-post-market-clinical-follow-up-for-medical-devices EU-MDR PMCF: Pläne, Berichte und Fristen https://www.pureglobal.com/assets/video-posters/MeeXg9C003BX00JkwSbbc1wtufRkp7btq3ZAbd1NDSxlo.jpg Ein Leitfaden zum Post-Market Clinical Follow-up unter der EU-MDR, einschließlich PMCF-Plänen, Bewertungsberichten und Fristen. https://stream.mux.com/MeeXg9C003BX00JkwSbbc1wtufRkp7btq3ZAbd1NDSxlo.m3u8 https://player.mux.com/MeeXg9C003BX00JkwSbbc1wtufRkp7btq3ZAbd1NDSxlo?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FMeeXg9C003BX00JkwSbbc1wtufRkp7btq3ZAbd1NDSxlo.jpg&accent-color=%232451c6 108 2026-10-16T04:58:54.123Z 2026-10-15 https://www.pureglobal.com/de/markets/european-union/eu-mdr-gspr-checklist-annex-i 2026-10-15 https://www.pureglobal.com/de/markets/european-union/eu-mdr-ivdr-person-responsible-for-regulatory-compliance-prrc EU-PRRC: Artikel-15-Anforderungen https://www.pureglobal.com/assets/video-posters/NcCR00V8nB5wmFTN7C1kJTBAa7Kmlmfi02ee7XwsMyuQM.jpg Verstehen Sie die PRRC-Rolle gemäß EU-MDR und IVDR Artikel 15, einschließlich Qualifikationen und Verantwortlichkeiten. https://stream.mux.com/NcCR00V8nB5wmFTN7C1kJTBAa7Kmlmfi02ee7XwsMyuQM.m3u8 https://player.mux.com/NcCR00V8nB5wmFTN7C1kJTBAa7Kmlmfi02ee7XwsMyuQM?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FNcCR00V8nB5wmFTN7C1kJTBAa7Kmlmfi02ee7XwsMyuQM.jpg&accent-color=%232451c6 108 2026-10-16T04:59:34.224Z 2026-10-15 https://www.pureglobal.com/de/markets/european-union/eu-mdr-psur-periodic-safety-update-report 2026-10-15 https://www.pureglobal.com/de/markets/european-union/eudamed-medical-device-ivd-registration 2026-10-15 https://www.pureglobal.com/de/markets/european-union/mdr-and-ivdr-postmarket-surveillance 2026-10-15 https://www.pureglobal.com/de/markets/hong-kong Hongkong MDACS: Freiwillige Listung https://www.pureglobal.com/assets/video-posters/01g3xtsRTru7Ig7A01vNe023Nr38jopQLEqTx6KLhqJ8RQ.jpg Entdecken Sie Hongkongs MDACS-Listungssystem, das CMPR und die in diesem Video behandelten Änderungen. https://stream.mux.com/01g3xtsRTru7Ig7A01vNe023Nr38jopQLEqTx6KLhqJ8RQ.m3u8 https://player.mux.com/01g3xtsRTru7Ig7A01vNe023Nr38jopQLEqTx6KLhqJ8RQ?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F01g3xtsRTru7Ig7A01vNe023Nr38jopQLEqTx6KLhqJ8RQ.jpg&accent-color=%232451c6 101 2026-10-16T04:59:15.866Z 2026-10-15 https://www.pureglobal.com/de/markets/india 2026-10-15 https://www.pureglobal.com/de/markets/indonesia 2026-10-15 https://www.pureglobal.com/de/markets/indonesia/medical-device-classification 2026-10-15 https://www.pureglobal.com/de/markets/indonesia/medical-device-labeling 2026-10-15 https://www.pureglobal.com/de/markets/indonesia/medical-device-postmarket-requirements 2026-10-15 https://www.pureglobal.com/de/markets/indonesia/medical-device-regulations 2026-10-15 https://www.pureglobal.com/de/markets/israel 2026-10-15 https://www.pureglobal.com/de/markets/japan 2026-10-15 https://www.pureglobal.com/de/markets/japan/marketing-authorization-holder-mah-dmah 2026-10-15 https://www.pureglobal.com/de/markets/macau 2026-10-15 https://www.pureglobal.com/de/markets/malaysia 2026-10-15 https://www.pureglobal.com/de/markets/malaysia/mda-medical-device-classification 2026-10-15 https://www.pureglobal.com/de/markets/malaysia/mda-medical-device-labeling 2026-10-15 https://www.pureglobal.com/de/markets/malaysia/mda-medical-device-postmarket-requirements 2026-10-15 https://www.pureglobal.com/de/markets/malaysia/mda-medical-device-regulations 2026-10-15 https://www.pureglobal.com/de/markets/mexico 2026-10-15 https://www.pureglobal.com/de/markets/mexico/cofepris-medical-device-and-ivd-classification 2026-10-15 https://www.pureglobal.com/de/markets/mexico/cofepris-medical-device-labeling 2026-10-15 https://www.pureglobal.com/de/markets/mexico/cofepris-medical-device-postmarket-compliance 2026-10-15 https://www.pureglobal.com/de/markets/mexico/cofepris-medical-device-regulations 2026-10-15 https://www.pureglobal.com/de/markets/new-zealand 2026-10-15 https://www.pureglobal.com/de/markets/pakistan 2026-10-15 https://www.pureglobal.com/de/markets/peru Peru DIGEMID: Registrierzeiten & Gebühren https://www.pureglobal.com/assets/video-posters/PgJluzdF01VY00Yazash8pKwFUhg8w02jyHeCw02sjh1VPM.jpg Erfahren Sie mehr über Perus Registrierungswege für Medizinprodukte sowie die im Video behandelten DIGEMID-Prüffristen und Gebühren. https://stream.mux.com/PgJluzdF01VY00Yazash8pKwFUhg8w02jyHeCw02sjh1VPM.m3u8 https://player.mux.com/PgJluzdF01VY00Yazash8pKwFUhg8w02jyHeCw02sjh1VPM?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FPgJluzdF01VY00Yazash8pKwFUhg8w02jyHeCw02sjh1VPM.jpg&accent-color=%232451c6 109 2026-10-16T05:00:08.644Z 2026-10-15 https://www.pureglobal.com/de/markets/philippines Philippinen FDA: CMDN oder CMDR? https://www.pureglobal.com/assets/video-posters/Hfkt6CXufVLkbOFBferCDgsxd0101j3BPO5R5ZQhxIdhU.jpg Verstehen Sie die CMDN- und CMDR-Wege der philippinischen FDA sowie die im Video besprochenen Registrierungsänderungen. https://stream.mux.com/Hfkt6CXufVLkbOFBferCDgsxd0101j3BPO5R5ZQhxIdhU.m3u8 https://player.mux.com/Hfkt6CXufVLkbOFBferCDgsxd0101j3BPO5R5ZQhxIdhU?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FHfkt6CXufVLkbOFBferCDgsxd0101j3BPO5R5ZQhxIdhU.jpg&accent-color=%232451c6 114 2026-10-16T04:59:00.292Z 2026-10-15 https://www.pureglobal.com/de/markets/saudi-arabia 2026-10-15 https://www.pureglobal.com/de/markets/singapore 2026-10-15 https://www.pureglobal.com/de/markets/singapore/hsa-medical-device-classification 2026-10-15 https://www.pureglobal.com/de/markets/singapore/hsa-medical-device-labeling 2026-10-15 https://www.pureglobal.com/de/markets/singapore/hsa-medical-device-postmarket-surveillance 2026-10-15 https://www.pureglobal.com/de/markets/singapore/hsa-medical-device-regulations 2026-10-15 https://www.pureglobal.com/de/markets/south-korea Südkorea MFDS: Produktregistrierung https://www.pureglobal.com/assets/video-posters/tRBfiLaVikYUQunZna7jnZgQOb81jfyeEhsQO78haX8.jpg Erkunden Sie Südkoreas Produktklassen, MFDS-Registrierungswege, Prüffristen und die fünfjährige Erneuerung. https://stream.mux.com/tRBfiLaVikYUQunZna7jnZgQOb81jfyeEhsQO78haX8.m3u8 https://player.mux.com/tRBfiLaVikYUQunZna7jnZgQOb81jfyeEhsQO78haX8?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FtRBfiLaVikYUQunZna7jnZgQOb81jfyeEhsQO78haX8.jpg&accent-color=%232451c6 104 2026-10-16T04:59:57.021Z 2026-10-15 https://www.pureglobal.com/de/markets/switzerland 2026-10-15 https://www.pureglobal.com/de/markets/taiwan 2026-10-15 https://www.pureglobal.com/de/markets/thailand 2026-10-15 https://www.pureglobal.com/de/markets/thailand/thailand-medical-device-and-ivd-classification 2026-10-15 https://www.pureglobal.com/de/markets/thailand/thailand-medical-device-and-ivd-labeling-requirements 2026-10-15 https://www.pureglobal.com/de/markets/thailand/thailand-medical-device-and-ivd-regulations 2026-10-15 https://www.pureglobal.com/de/markets/thailand/thailand-medical-device-post-market-requirements 2026-10-15 https://www.pureglobal.com/de/markets/uae 2026-10-15 https://www.pureglobal.com/de/markets/united-kingdom 2026-10-15 https://www.pureglobal.com/de/markets/united-kingdom/uk-responsible-person-medical-devices 2026-10-15 https://www.pureglobal.com/de/markets/united-states 2026-10-15 https://www.pureglobal.com/de/markets/united-states/fda-21-cfr-part-801-medical-device-labeling-and-iso-15223-symbols 2026-10-15 https://www.pureglobal.com/de/markets/united-states/fda-483-and-warning-letter-response-and-consulting FDA Form 483: Antworten & Warning Letters https://www.pureglobal.com/assets/video-posters/binE4h84L7wmSv6V9M9p75OaUNQkD8H6oRA2pfQ4YYM.jpg Verstehen Sie Form-483-Feststellungen, Antwortfristen, Warning Letters und Ergebnisse von FDA-Inspektionen. https://stream.mux.com/binE4h84L7wmSv6V9M9p75OaUNQkD8H6oRA2pfQ4YYM.m3u8 https://player.mux.com/binE4h84L7wmSv6V9M9p75OaUNQkD8H6oRA2pfQ4YYM?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FbinE4h84L7wmSv6V9M9p75OaUNQkD8H6oRA2pfQ4YYM.jpg&accent-color=%232451c6 108 2026-10-16T04:57:51.770Z 2026-10-15 https://www.pureglobal.com/de/markets/united-states/fda-biocompatibility-iso-10993-evaluation-guide 2026-10-15 https://www.pureglobal.com/de/markets/united-states/fda-certificate-to-foreign-government-cfg-for-medical-devices FDA CFG: Zertifikate für Produktexporte https://www.pureglobal.com/assets/video-posters/fS276ccoWXokDxwtDforbRhDHmMWdtaxx67gerBBBeE.jpg Erfahren Sie, was ein FDA Certificate to Foreign Government abdeckt, wann Exporteure es benötigen und wie Anträge ablaufen. https://stream.mux.com/fS276ccoWXokDxwtDforbRhDHmMWdtaxx67gerBBBeE.m3u8 https://player.mux.com/fS276ccoWXokDxwtDforbRhDHmMWdtaxx67gerBBBeE?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FfS276ccoWXokDxwtDforbRhDHmMWdtaxx67gerBBBeE.jpg&accent-color=%232451c6 107 2026-10-16T04:58:42.168Z 2026-10-15 https://www.pureglobal.com/de/markets/united-states/fda-de-novo-classification-request 2026-10-15 https://www.pureglobal.com/de/markets/united-states/fda-estar-submission-template-guide 2026-10-15 https://www.pureglobal.com/de/markets/united-states/fda-ide-and-breakthrough-device-designation-guide 2026-10-15 https://www.pureglobal.com/de/markets/united-states/fda-medical-device-reporting-mdr-consulting FDA MDR: Medizinprodukte-Meldewesen https://www.pureglobal.com/assets/video-posters/AkU7r439f004ndRky18ENwIzhgrzkb28GCKrfrReVjYM.jpg Ein Überblick über 21 CFR 803, Meldefristen für Medizinprodukte, Fünf-Tage-Berichte und elektronische MDR-Meldungen. https://stream.mux.com/AkU7r439f004ndRky18ENwIzhgrzkb28GCKrfrReVjYM.m3u8 https://player.mux.com/AkU7r439f004ndRky18ENwIzhgrzkb28GCKrfrReVjYM?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FAkU7r439f004ndRky18ENwIzhgrzkb28GCKrfrReVjYM.jpg&accent-color=%232451c6 109 2026-10-16T04:58:11.613Z 2026-10-15 https://www.pureglobal.com/de/markets/united-states/fda-pre-sub-guidance-and-q-sub-guidance-for-medical-devices FDA Pre-Sub: Der Q-Submission-Prozess https://www.pureglobal.com/assets/video-posters/be1w25SmygP8Eg02Vh3JuxdRmF8LXQyxZRgtgWwy01YUI.jpg Verstehen Sie FDA Pre-Sub-Meetings, Q-Submission-Arten, Fristen und wie Sie gezielte Fragen vorbereiten. https://stream.mux.com/be1w25SmygP8Eg02Vh3JuxdRmF8LXQyxZRgtgWwy01YUI.m3u8 https://player.mux.com/be1w25SmygP8Eg02Vh3JuxdRmF8LXQyxZRgtgWwy01YUI?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2Fbe1w25SmygP8Eg02Vh3JuxdRmF8LXQyxZRgtgWwy01YUI.jpg&accent-color=%232451c6 105 2026-10-16T04:58:29.478Z 2026-10-15 https://www.pureglobal.com/de/markets/united-states/fda-premarket-approval-pma-submission-consulting-for-medical-devices FDA PMA: Premarket Approval erklärt https://www.pureglobal.com/assets/video-posters/WEZQpF8YhdddbBNLteXLBkpxiekr4EqDJD39okgMqKg.jpg Erfahren Sie, wann ein Produkt eine FDA-Premarket-Approval benötigt und wie PMA-Nachweise, Gebühren und Prüffristen zusammenhängen. https://stream.mux.com/WEZQpF8YhdddbBNLteXLBkpxiekr4EqDJD39okgMqKg.m3u8 https://player.mux.com/WEZQpF8YhdddbBNLteXLBkpxiekr4EqDJD39okgMqKg?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FWEZQpF8YhdddbBNLteXLBkpxiekr4EqDJD39okgMqKg.jpg&accent-color=%232451c6 105 2026-10-16T04:59:06.512Z 2026-10-15 https://www.pureglobal.com/de/markets/united-states/fda-recognized-consensus-standards-and-doc-guide 2026-10-15 https://www.pureglobal.com/de/markets/united-states/fda-udi-and-gudid-database-submission-guide 2026-10-15 https://www.pureglobal.com/de/markets/united-states/us-fda-510k-clearance-submission-consulting FDA 510(k): Freigabe & Einreichung https://www.pureglobal.com/assets/video-posters/9eLZMqKyqjKGI02yLiOYiSg9QwaewYbYkd2NVn00ZZJxg.jpg Entdecken Sie wesentliche Äquivalenz, Prädikate, eSTAR und die im Video behandelten Einreichungsgebühren für FDA 510(k). https://stream.mux.com/9eLZMqKyqjKGI02yLiOYiSg9QwaewYbYkd2NVn00ZZJxg.m3u8 https://player.mux.com/9eLZMqKyqjKGI02yLiOYiSg9QwaewYbYkd2NVn00ZZJxg?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F9eLZMqKyqjKGI02yLiOYiSg9QwaewYbYkd2NVn00ZZJxg.jpg&accent-color=%232451c6 111 2026-10-16T04:58:34.086Z 2026-10-15 https://www.pureglobal.com/de/markets/united-states/us-fda-agent-for-medical-devices-companies 2026-10-15 https://www.pureglobal.com/de/markets/united-states/us-fda-medical-device-and-ivd-classification-consulting 2026-10-15 https://www.pureglobal.com/de/markets/united-states/us-fda-medical-device-establishment-registration-and-device-listing 2026-10-15 https://www.pureglobal.com/de/markets/united-states/us-fda-qmsr-consulting-for-medical-devices 2026-10-15 https://www.pureglobal.com/de/markets/vietnam 2026-10-15 https://www.pureglobal.com/de/markets/vietnam/vietnam-medical-device-and-ivd-classification-and-grouping 2026-10-15 https://www.pureglobal.com/de/markets/vietnam/vietnam-medical-device-and-ivd-post-market-requirements 2026-10-15 https://www.pureglobal.com/de/markets/vietnam/vietnam-medical-device-and-ivd-regulations 2026-10-15 https://www.pureglobal.com/de/markets/vietnam/vietnam-medical-device-labeling-requirements 2026-10-15 https://www.pureglobal.com/es/markets 2026-06-17 https://www.pureglobal.com/es/markets/argentina 2026-10-15 https://www.pureglobal.com/es/markets/australia 2026-10-15 https://www.pureglobal.com/es/markets/australia/artg-sponsor-manufacturer-evidence 2026-10-15 https://www.pureglobal.com/es/markets/bangladesh 2026-10-15 https://www.pureglobal.com/es/markets/brazil 2026-10-15 https://www.pureglobal.com/es/markets/brazil/ai-brazil-anvisa-submissions 2026-10-15 https://www.pureglobal.com/es/markets/brazil/anvisa-medical-device-classification 2026-10-15 https://www.pureglobal.com/es/markets/brazil/anvisa-medical-device-labeling 2026-10-15 https://www.pureglobal.com/es/markets/brazil/anvisa-medical-device-postmarket-surveillance 2026-10-15 https://www.pureglobal.com/es/markets/brazil/anvisa-medical-device-regulations 2026-10-15 https://www.pureglobal.com/es/markets/brazil/inmetro-anatel-medical-device-certification 2026-10-15 https://www.pureglobal.com/es/markets/canada 2026-10-15 https://www.pureglobal.com/es/markets/canada/medical-device-licence-mdl-vs-mdel 2026-10-15 https://www.pureglobal.com/es/markets/china China NMPA: vías de registro https://www.pureglobal.com/assets/video-posters/Py5Uz9dIR02qXfIy7796D02yWaXwfVtG023CqZO2CL02gE00.jpg Guía en video sobre clases de dispositivos de NMPA, vías de registro, plazos de revisión y el marco GMP para dispositivos médicos en China. https://stream.mux.com/Py5Uz9dIR02qXfIy7796D02yWaXwfVtG023CqZO2CL02gE00.m3u8 https://player.mux.com/Py5Uz9dIR02qXfIy7796D02yWaXwfVtG023CqZO2CL02gE00?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FPy5Uz9dIR02qXfIy7796D02yWaXwfVtG023CqZO2CL02gE00.jpg&accent-color=%232451c6 115 2026-10-16T04:59:21.203Z 2026-10-15 https://www.pureglobal.com/es/markets/colombia 2026-10-15 https://www.pureglobal.com/es/markets/colombia/invima-medical-device-classification 2026-10-15 https://www.pureglobal.com/es/markets/colombia/invima-medical-device-labeling 2026-10-15 https://www.pureglobal.com/es/markets/colombia/invima-medical-device-postmarket-compliance 2026-10-15 https://www.pureglobal.com/es/markets/colombia/invima-medical-device-regulations 2026-10-15 https://www.pureglobal.com/es/markets/costa-rica 2026-10-15 https://www.pureglobal.com/es/markets/egypt 2026-10-15 https://www.pureglobal.com/es/markets/european-union 2026-10-15 https://www.pureglobal.com/es/markets/european-union/ce-mark-notified-body-search MDR de la UE: cómo elegir un organismo notificado https://www.pureglobal.com/assets/video-posters/hm5Pl53mUXV00dpBZdTCSQ02AnNlLWYnTs2PIbnOEbGO00.jpg Aprenda a usar NANDO para consultar la designación y alcance de un organismo notificado para su dispositivo bajo el MDR de la UE. https://stream.mux.com/hm5Pl53mUXV00dpBZdTCSQ02AnNlLWYnTs2PIbnOEbGO00.m3u8 https://player.mux.com/hm5Pl53mUXV00dpBZdTCSQ02AnNlLWYnTs2PIbnOEbGO00?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2Fhm5Pl53mUXV00dpBZdTCSQ02AnNlLWYnTs2PIbnOEbGO00.jpg&accent-color=%232451c6 104 2026-10-16T04:58:47.608Z 2026-10-15 https://www.pureglobal.com/es/markets/european-union/ec-european-authorized-representative Representante autorizado UE: art. 11 https://www.pureglobal.com/assets/video-posters/8f2diZEFPEGBYwbxgEpcIL81gUNdow1kmcCTRB00WES4.jpg Sepa cuándo se necesita un representante autorizado en la UE y qué exige el Artículo 11 del MDR y del IVDR. https://stream.mux.com/8f2diZEFPEGBYwbxgEpcIL81gUNdow1kmcCTRB00WES4.m3u8 https://player.mux.com/8f2diZEFPEGBYwbxgEpcIL81gUNdow1kmcCTRB00WES4?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F8f2diZEFPEGBYwbxgEpcIL81gUNdow1kmcCTRB00WES4.jpg&accent-color=%232451c6 100 2026-10-16T04:59:45.925Z 2026-10-15 https://www.pureglobal.com/es/markets/european-union/eu-ivdr-consulting 2026-10-15 https://www.pureglobal.com/es/markets/european-union/eu-ivdr-consulting/ce-marking-approval-for-ivds 2026-10-15 https://www.pureglobal.com/es/markets/european-union/eu-ivdr-consulting/ivdr-classification IVDR: clases A–D y plazos de transición https://www.pureglobal.com/assets/video-posters/xFfNtUAJbK9nQD6IlZ41k13i47i2GVxwTtp2JBBYoVA.jpg Explore la clasificación del IVDR, las reglas del Anexo VIII y los plazos de transición para IVD legados tratados en este video. https://stream.mux.com/xFfNtUAJbK9nQD6IlZ41k13i47i2GVxwTtp2JBBYoVA.m3u8 https://player.mux.com/xFfNtUAJbK9nQD6IlZ41k13i47i2GVxwTtp2JBBYoVA?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FxFfNtUAJbK9nQD6IlZ41k13i47i2GVxwTtp2JBBYoVA.jpg&accent-color=%232451c6 117 2026-10-16T04:59:40.284Z 2026-10-15 https://www.pureglobal.com/es/markets/european-union/eu-ivdr-consulting/ivdr-per-performance-evaluation-report 2026-10-15 https://www.pureglobal.com/es/markets/european-union/eu-ivdr-consulting/pmpf-postmarket-performance 2026-10-15 https://www.pureglobal.com/es/markets/european-union/eu-mdr-consulting 2026-10-15 https://www.pureglobal.com/es/markets/european-union/eu-mdr-consulting/eu-mdr-ce-marking-approval-for-medical-devices 2026-10-15 https://www.pureglobal.com/es/markets/european-union/eu-mdr-consulting/eu-mdr-classification-for-medical-devices MDR de la UE: reglas de clasificación de dispositivos https://www.pureglobal.com/assets/video-posters/E67JA1rg012v0002bCwrk6gZzbkcuT8EyFB19PUTqDzJMQ.jpg Sepa cómo las 22 reglas del Anexo VIII definen las clases bajo el MDR de la UE y cómo aplicar la regla más estricta. https://stream.mux.com/E67JA1rg012v0002bCwrk6gZzbkcuT8EyFB19PUTqDzJMQ.m3u8 https://player.mux.com/E67JA1rg012v0002bCwrk6gZzbkcuT8EyFB19PUTqDzJMQ?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FE67JA1rg012v0002bCwrk6gZzbkcuT8EyFB19PUTqDzJMQ.jpg&accent-color=%232451c6 108 2026-10-16T04:59:27.006Z 2026-10-15 https://www.pureglobal.com/es/markets/european-union/eu-mdr-consulting/eu-mdr-clinical-evaluation-reports-cer-for-medical-devices MDR de la UE: informes de evaluación clínica https://www.pureglobal.com/assets/video-posters/teVFqOlFbuce01lKbdwr2d013lyRTQYKcsR7apvEpQMTI.jpg Introducción al informe de evaluación clínica bajo el MDR de la UE, requisitos de evidencia y actualización del CER. https://stream.mux.com/teVFqOlFbuce01lKbdwr2d013lyRTQYKcsR7apvEpQMTI.m3u8 https://player.mux.com/teVFqOlFbuce01lKbdwr2d013lyRTQYKcsR7apvEpQMTI?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FteVFqOlFbuce01lKbdwr2d013lyRTQYKcsR7apvEpQMTI.jpg&accent-color=%232451c6 110 2026-10-16T04:59:53.863Z 2026-10-15 https://www.pureglobal.com/es/markets/european-union/eu-mdr-consulting/eu-pmcf-post-market-clinical-follow-up-for-medical-devices EU MDR PMCF: planes, informes y plazos https://www.pureglobal.com/assets/video-posters/MeeXg9C003BX00JkwSbbc1wtufRkp7btq3ZAbd1NDSxlo.jpg Guía de seguimiento clínico poscomercialización bajo el MDR de la UE, incluidos planes de PMCF, reportes de evaluación y plazos. https://stream.mux.com/MeeXg9C003BX00JkwSbbc1wtufRkp7btq3ZAbd1NDSxlo.m3u8 https://player.mux.com/MeeXg9C003BX00JkwSbbc1wtufRkp7btq3ZAbd1NDSxlo?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FMeeXg9C003BX00JkwSbbc1wtufRkp7btq3ZAbd1NDSxlo.jpg&accent-color=%232451c6 108 2026-10-16T04:58:54.123Z 2026-10-15 https://www.pureglobal.com/es/markets/european-union/eu-mdr-gspr-checklist-annex-i 2026-10-15 https://www.pureglobal.com/es/markets/european-union/eu-mdr-ivdr-person-responsible-for-regulatory-compliance-prrc EU PRRC: requisitos del Artículo 15 https://www.pureglobal.com/assets/video-posters/NcCR00V8nB5wmFTN7C1kJTBAa7Kmlmfi02ee7XwsMyuQM.jpg Comprenda la función de la PRRC según el Artículo 15 del MDR e IVDR de la UE, incluyendo requisitos y responsabilidades. https://stream.mux.com/NcCR00V8nB5wmFTN7C1kJTBAa7Kmlmfi02ee7XwsMyuQM.m3u8 https://player.mux.com/NcCR00V8nB5wmFTN7C1kJTBAa7Kmlmfi02ee7XwsMyuQM?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FNcCR00V8nB5wmFTN7C1kJTBAa7Kmlmfi02ee7XwsMyuQM.jpg&accent-color=%232451c6 108 2026-10-16T04:59:34.224Z 2026-10-15 https://www.pureglobal.com/es/markets/european-union/eu-mdr-psur-periodic-safety-update-report 2026-10-15 https://www.pureglobal.com/es/markets/european-union/eudamed-medical-device-ivd-registration 2026-10-15 https://www.pureglobal.com/es/markets/european-union/mdr-and-ivdr-postmarket-surveillance 2026-10-15 https://www.pureglobal.com/es/markets/hong-kong MDACS de Hong Kong: listado voluntario https://www.pureglobal.com/assets/video-posters/01g3xtsRTru7Ig7A01vNe023Nr38jopQLEqTx6KLhqJ8RQ.jpg Explore el marco de listado MDACS de Hong Kong, el CMPR y los cambios tratados en este video. https://stream.mux.com/01g3xtsRTru7Ig7A01vNe023Nr38jopQLEqTx6KLhqJ8RQ.m3u8 https://player.mux.com/01g3xtsRTru7Ig7A01vNe023Nr38jopQLEqTx6KLhqJ8RQ?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F01g3xtsRTru7Ig7A01vNe023Nr38jopQLEqTx6KLhqJ8RQ.jpg&accent-color=%232451c6 101 2026-10-16T04:59:15.866Z 2026-10-15 https://www.pureglobal.com/es/markets/india 2026-10-15 https://www.pureglobal.com/es/markets/indonesia 2026-10-15 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https://www.pureglobal.com/es/markets/malaysia/mda-medical-device-regulations 2026-10-15 https://www.pureglobal.com/es/markets/mexico 2026-10-15 https://www.pureglobal.com/es/markets/mexico/cofepris-medical-device-and-ivd-classification 2026-10-15 https://www.pureglobal.com/es/markets/mexico/cofepris-medical-device-labeling 2026-10-15 https://www.pureglobal.com/es/markets/mexico/cofepris-medical-device-postmarket-compliance 2026-10-15 https://www.pureglobal.com/es/markets/mexico/cofepris-medical-device-regulations 2026-10-15 https://www.pureglobal.com/es/markets/new-zealand 2026-10-15 https://www.pureglobal.com/es/markets/pakistan 2026-10-15 https://www.pureglobal.com/es/markets/peru Perú DIGEMID: plazos de registro y tarifas https://www.pureglobal.com/assets/video-posters/PgJluzdF01VY00Yazash8pKwFUhg8w02jyHeCw02sjh1VPM.jpg Conozca las vías de registro de dispositivos médicos en Perú y los plazos de revisión y tarifas de DIGEMID tratados en este video. https://stream.mux.com/PgJluzdF01VY00Yazash8pKwFUhg8w02jyHeCw02sjh1VPM.m3u8 https://player.mux.com/PgJluzdF01VY00Yazash8pKwFUhg8w02jyHeCw02sjh1VPM?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FPgJluzdF01VY00Yazash8pKwFUhg8w02jyHeCw02sjh1VPM.jpg&accent-color=%232451c6 109 2026-10-16T05:00:08.644Z 2026-10-15 https://www.pureglobal.com/es/markets/philippines FDA de Filipinas: ¿CMDN o CMDR? https://www.pureglobal.com/assets/video-posters/Hfkt6CXufVLkbOFBferCDgsxd0101j3BPO5R5ZQhxIdhU.jpg Comprenda las vías CMDN y CMDR de la FDA de Filipinas y los cambios de registro tratados en este video. https://stream.mux.com/Hfkt6CXufVLkbOFBferCDgsxd0101j3BPO5R5ZQhxIdhU.m3u8 https://player.mux.com/Hfkt6CXufVLkbOFBferCDgsxd0101j3BPO5R5ZQhxIdhU?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FHfkt6CXufVLkbOFBferCDgsxd0101j3BPO5R5ZQhxIdhU.jpg&accent-color=%232451c6 114 2026-10-16T04:59:00.292Z 2026-10-15 https://www.pureglobal.com/es/markets/saudi-arabia 2026-10-15 https://www.pureglobal.com/es/markets/singapore 2026-10-15 https://www.pureglobal.com/es/markets/singapore/hsa-medical-device-classification 2026-10-15 https://www.pureglobal.com/es/markets/singapore/hsa-medical-device-labeling 2026-10-15 https://www.pureglobal.com/es/markets/singapore/hsa-medical-device-postmarket-surveillance 2026-10-15 https://www.pureglobal.com/es/markets/singapore/hsa-medical-device-regulations 2026-10-15 https://www.pureglobal.com/es/markets/south-korea Corea del Sur MFDS: registro de dispositivos https://www.pureglobal.com/assets/video-posters/tRBfiLaVikYUQunZna7jnZgQOb81jfyeEhsQO78haX8.jpg Explore las clases de dispositivos de Corea del Sur, las vías de registro de MFDS, los plazos de revisión y la renovación quinquenal. https://stream.mux.com/tRBfiLaVikYUQunZna7jnZgQOb81jfyeEhsQO78haX8.m3u8 https://player.mux.com/tRBfiLaVikYUQunZna7jnZgQOb81jfyeEhsQO78haX8?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FtRBfiLaVikYUQunZna7jnZgQOb81jfyeEhsQO78haX8.jpg&accent-color=%232451c6 104 2026-10-16T04:59:57.021Z 2026-10-15 https://www.pureglobal.com/es/markets/switzerland 2026-10-15 https://www.pureglobal.com/es/markets/taiwan 2026-10-15 https://www.pureglobal.com/es/markets/thailand 2026-10-15 https://www.pureglobal.com/es/markets/thailand/thailand-medical-device-and-ivd-classification 2026-10-15 https://www.pureglobal.com/es/markets/thailand/thailand-medical-device-and-ivd-labeling-requirements 2026-10-15 https://www.pureglobal.com/es/markets/thailand/thailand-medical-device-and-ivd-regulations 2026-10-15 https://www.pureglobal.com/es/markets/thailand/thailand-medical-device-post-market-requirements 2026-10-15 https://www.pureglobal.com/es/markets/uae 2026-10-15 https://www.pureglobal.com/es/markets/united-kingdom 2026-10-15 https://www.pureglobal.com/es/markets/united-kingdom/uk-responsible-person-medical-devices 2026-10-15 https://www.pureglobal.com/es/markets/united-states 2026-10-15 https://www.pureglobal.com/es/markets/united-states/fda-21-cfr-part-801-medical-device-labeling-and-iso-15223-symbols 2026-10-15 https://www.pureglobal.com/es/markets/united-states/fda-483-and-warning-letter-response-and-consulting FDA Form 483: respuestas y advertencias https://www.pureglobal.com/assets/video-posters/binE4h84L7wmSv6V9M9p75OaUNQkD8H6oRA2pfQ4YYM.jpg Comprenda las observaciones del Formulario 483, plazos de respuesta, cartas de advertencia y resultados de inspección de FDA. https://stream.mux.com/binE4h84L7wmSv6V9M9p75OaUNQkD8H6oRA2pfQ4YYM.m3u8 https://player.mux.com/binE4h84L7wmSv6V9M9p75OaUNQkD8H6oRA2pfQ4YYM?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FbinE4h84L7wmSv6V9M9p75OaUNQkD8H6oRA2pfQ4YYM.jpg&accent-color=%232451c6 108 2026-10-16T04:57:51.770Z 2026-10-15 https://www.pureglobal.com/es/markets/united-states/fda-biocompatibility-iso-10993-evaluation-guide 2026-10-15 https://www.pureglobal.com/es/markets/united-states/fda-certificate-to-foreign-government-cfg-for-medical-devices FDA CFG: certificados de exportación https://www.pureglobal.com/assets/video-posters/fS276ccoWXokDxwtDforbRhDHmMWdtaxx67gerBBBeE.jpg Descubra qué cubre un Certificado para Gobierno Extranjero de FDA, cuándo lo necesitan los exportadores y cómo tramitarlo. https://stream.mux.com/fS276ccoWXokDxwtDforbRhDHmMWdtaxx67gerBBBeE.m3u8 https://player.mux.com/fS276ccoWXokDxwtDforbRhDHmMWdtaxx67gerBBBeE?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FfS276ccoWXokDxwtDforbRhDHmMWdtaxx67gerBBBeE.jpg&accent-color=%232451c6 107 2026-10-16T04:58:42.168Z 2026-10-15 https://www.pureglobal.com/es/markets/united-states/fda-de-novo-classification-request 2026-10-15 https://www.pureglobal.com/es/markets/united-states/fda-estar-submission-template-guide 2026-10-15 https://www.pureglobal.com/es/markets/united-states/fda-ide-and-breakthrough-device-designation-guide 2026-10-15 https://www.pureglobal.com/es/markets/united-states/fda-medical-device-reporting-mdr-consulting FDA MDR: reporte de dispositivos https://www.pureglobal.com/assets/video-posters/AkU7r439f004ndRky18ENwIzhgrzkb28GCKrfrReVjYM.jpg Panorama de 21 CFR 803, plazos de reporte de dispositivos médicos, informes de 5 días y envíos electrónicos de MDR. https://stream.mux.com/AkU7r439f004ndRky18ENwIzhgrzkb28GCKrfrReVjYM.m3u8 https://player.mux.com/AkU7r439f004ndRky18ENwIzhgrzkb28GCKrfrReVjYM?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FAkU7r439f004ndRky18ENwIzhgrzkb28GCKrfrReVjYM.jpg&accent-color=%232451c6 109 2026-10-16T04:58:11.613Z 2026-10-15 https://www.pureglobal.com/es/markets/united-states/fda-pre-sub-guidance-and-q-sub-guidance-for-medical-devices FDA Pre-Sub: proceso de Q-Submission https://www.pureglobal.com/assets/video-posters/be1w25SmygP8Eg02Vh3JuxdRmF8LXQyxZRgtgWwy01YUI.jpg Comprenda las reuniones Pre-Sub de FDA, tipos de Q-Submission, plazos y cómo preparar preguntas bien enfocadas. https://stream.mux.com/be1w25SmygP8Eg02Vh3JuxdRmF8LXQyxZRgtgWwy01YUI.m3u8 https://player.mux.com/be1w25SmygP8Eg02Vh3JuxdRmF8LXQyxZRgtgWwy01YUI?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2Fbe1w25SmygP8Eg02Vh3JuxdRmF8LXQyxZRgtgWwy01YUI.jpg&accent-color=%232451c6 105 2026-10-16T04:58:29.478Z 2026-10-15 https://www.pureglobal.com/es/markets/united-states/fda-premarket-approval-pma-submission-consulting-for-medical-devices FDA PMA: aprobación precomercial https://www.pureglobal.com/assets/video-posters/WEZQpF8YhdddbBNLteXLBkpxiekr4EqDJD39okgMqKg.jpg Sepa cuándo un producto requiere aprobación precomercial de FDA y cómo se articulan las pruebas del PMA, tarifas y plazos. https://stream.mux.com/WEZQpF8YhdddbBNLteXLBkpxiekr4EqDJD39okgMqKg.m3u8 https://player.mux.com/WEZQpF8YhdddbBNLteXLBkpxiekr4EqDJD39okgMqKg?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FWEZQpF8YhdddbBNLteXLBkpxiekr4EqDJD39okgMqKg.jpg&accent-color=%232451c6 105 2026-10-16T04:59:06.512Z 2026-10-15 https://www.pureglobal.com/es/markets/united-states/fda-recognized-consensus-standards-and-doc-guide 2026-10-15 https://www.pureglobal.com/es/markets/united-states/fda-udi-and-gudid-database-submission-guide 2026-10-15 https://www.pureglobal.com/es/markets/united-states/us-fda-510k-clearance-submission-consulting FDA 510(k): autorización y presentación https://www.pureglobal.com/assets/video-posters/9eLZMqKyqjKGI02yLiOYiSg9QwaewYbYkd2NVn00ZZJxg.jpg Explore la equivalencia sustancial, los predicados, eSTAR y las tarifas de presentación FDA 510(k) tratadas en este video. https://stream.mux.com/9eLZMqKyqjKGI02yLiOYiSg9QwaewYbYkd2NVn00ZZJxg.m3u8 https://player.mux.com/9eLZMqKyqjKGI02yLiOYiSg9QwaewYbYkd2NVn00ZZJxg?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F9eLZMqKyqjKGI02yLiOYiSg9QwaewYbYkd2NVn00ZZJxg.jpg&accent-color=%232451c6 111 2026-10-16T04:58:34.086Z 2026-10-15 https://www.pureglobal.com/es/markets/united-states/us-fda-agent-for-medical-devices-companies 2026-10-15 https://www.pureglobal.com/es/markets/united-states/us-fda-medical-device-and-ivd-classification-consulting 2026-10-15 https://www.pureglobal.com/es/markets/united-states/us-fda-medical-device-establishment-registration-and-device-listing 2026-10-15 https://www.pureglobal.com/es/markets/united-states/us-fda-qmsr-consulting-for-medical-devices 2026-10-15 https://www.pureglobal.com/es/markets/vietnam 2026-10-15 https://www.pureglobal.com/es/markets/vietnam/vietnam-medical-device-and-ivd-classification-and-grouping 2026-10-15 https://www.pureglobal.com/es/markets/vietnam/vietnam-medical-device-and-ivd-post-market-requirements 2026-10-15 https://www.pureglobal.com/es/markets/vietnam/vietnam-medical-device-and-ivd-regulations 2026-10-15 https://www.pureglobal.com/es/markets/vietnam/vietnam-medical-device-labeling-requirements 2026-10-15 https://www.pureglobal.com/fr/markets 2026-06-17 https://www.pureglobal.com/fr/markets/argentina 2026-10-15 https://www.pureglobal.com/fr/markets/australia 2026-10-15 https://www.pureglobal.com/fr/markets/australia/artg-sponsor-manufacturer-evidence 2026-10-15 https://www.pureglobal.com/fr/markets/bangladesh 2026-10-15 https://www.pureglobal.com/fr/markets/brazil 2026-10-15 https://www.pureglobal.com/fr/markets/brazil/ai-brazil-anvisa-submissions 2026-10-15 https://www.pureglobal.com/fr/markets/brazil/anvisa-medical-device-classification 2026-10-15 https://www.pureglobal.com/fr/markets/brazil/anvisa-medical-device-labeling 2026-10-15 https://www.pureglobal.com/fr/markets/brazil/anvisa-medical-device-postmarket-surveillance 2026-10-15 https://www.pureglobal.com/fr/markets/brazil/anvisa-medical-device-regulations 2026-10-15 https://www.pureglobal.com/fr/markets/brazil/inmetro-anatel-medical-device-certification 2026-10-15 https://www.pureglobal.com/fr/markets/canada 2026-10-15 https://www.pureglobal.com/fr/markets/canada/medical-device-licence-mdl-vs-mdel 2026-10-15 https://www.pureglobal.com/fr/markets/china Chine NMPA : voies d'enregistrement https://www.pureglobal.com/assets/video-posters/Py5Uz9dIR02qXfIy7796D02yWaXwfVtG023CqZO2CL02gE00.jpg Guide vidéo : classes de dispositifs NMPA, voies d'enregistrement, délais et cadre BPF des dispositifs médicaux en Chine. https://stream.mux.com/Py5Uz9dIR02qXfIy7796D02yWaXwfVtG023CqZO2CL02gE00.m3u8 https://player.mux.com/Py5Uz9dIR02qXfIy7796D02yWaXwfVtG023CqZO2CL02gE00?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FPy5Uz9dIR02qXfIy7796D02yWaXwfVtG023CqZO2CL02gE00.jpg&accent-color=%232451c6 115 2026-10-16T04:59:21.203Z 2026-10-15 https://www.pureglobal.com/fr/markets/colombia 2026-10-15 https://www.pureglobal.com/fr/markets/colombia/invima-medical-device-classification 2026-10-15 https://www.pureglobal.com/fr/markets/colombia/invima-medical-device-labeling 2026-10-15 https://www.pureglobal.com/fr/markets/colombia/invima-medical-device-postmarket-compliance 2026-10-15 https://www.pureglobal.com/fr/markets/colombia/invima-medical-device-regulations 2026-10-15 https://www.pureglobal.com/fr/markets/costa-rica 2026-10-15 https://www.pureglobal.com/fr/markets/egypt 2026-10-15 https://www.pureglobal.com/fr/markets/european-union 2026-10-15 https://www.pureglobal.com/fr/markets/european-union/ce-mark-notified-body-search MDR UE : choisir un organisme notifié https://www.pureglobal.com/assets/video-posters/hm5Pl53mUXV00dpBZdTCSQ02AnNlLWYnTs2PIbnOEbGO00.jpg Découvrez comment utiliser NANDO pour vérifier la désignation et la portée d'un organisme notifié pour votre dispositif selon le MDR de l'UE. https://stream.mux.com/hm5Pl53mUXV00dpBZdTCSQ02AnNlLWYnTs2PIbnOEbGO00.m3u8 https://player.mux.com/hm5Pl53mUXV00dpBZdTCSQ02AnNlLWYnTs2PIbnOEbGO00?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2Fhm5Pl53mUXV00dpBZdTCSQ02AnNlLWYnTs2PIbnOEbGO00.jpg&accent-color=%232451c6 104 2026-10-16T04:58:47.608Z 2026-10-15 https://www.pureglobal.com/fr/markets/european-union/ec-european-authorized-representative Mandataires dans l'UE : article 11 https://www.pureglobal.com/assets/video-posters/8f2diZEFPEGBYwbxgEpcIL81gUNdow1kmcCTRB00WES4.jpg Découvrez quand un mandataire européen est requis et ce qu'exige l'article 11 du MDR et de l'IVDR. https://stream.mux.com/8f2diZEFPEGBYwbxgEpcIL81gUNdow1kmcCTRB00WES4.m3u8 https://player.mux.com/8f2diZEFPEGBYwbxgEpcIL81gUNdow1kmcCTRB00WES4?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F8f2diZEFPEGBYwbxgEpcIL81gUNdow1kmcCTRB00WES4.jpg&accent-color=%232451c6 100 2026-10-16T04:59:45.925Z 2026-10-15 https://www.pureglobal.com/fr/markets/european-union/eu-ivdr-consulting 2026-10-15 https://www.pureglobal.com/fr/markets/european-union/eu-ivdr-consulting/ce-marking-approval-for-ivds 2026-10-15 https://www.pureglobal.com/fr/markets/european-union/eu-ivdr-consulting/ivdr-classification IVDR : classes A–D et échéances de transition https://www.pureglobal.com/assets/video-posters/xFfNtUAJbK9nQD6IlZ41k13i47i2GVxwTtp2JBBYoVA.jpg Découvrez la classification IVDR, les règles de l'annexe VIII et les échéances de transition pour les DIV existants abordées ici. https://stream.mux.com/xFfNtUAJbK9nQD6IlZ41k13i47i2GVxwTtp2JBBYoVA.m3u8 https://player.mux.com/xFfNtUAJbK9nQD6IlZ41k13i47i2GVxwTtp2JBBYoVA?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FxFfNtUAJbK9nQD6IlZ41k13i47i2GVxwTtp2JBBYoVA.jpg&accent-color=%232451c6 117 2026-10-16T04:59:40.284Z 2026-10-15 https://www.pureglobal.com/fr/markets/european-union/eu-ivdr-consulting/ivdr-per-performance-evaluation-report 2026-10-15 https://www.pureglobal.com/fr/markets/european-union/eu-ivdr-consulting/pmpf-postmarket-performance 2026-10-15 https://www.pureglobal.com/fr/markets/european-union/eu-mdr-consulting 2026-10-15 https://www.pureglobal.com/fr/markets/european-union/eu-mdr-consulting/eu-mdr-ce-marking-approval-for-medical-devices 2026-10-15 https://www.pureglobal.com/fr/markets/european-union/eu-mdr-consulting/eu-mdr-classification-for-medical-devices EU MDR : règles de classification des dispositifs https://www.pureglobal.com/assets/video-posters/E67JA1rg012v0002bCwrk6gZzbkcuT8EyFB19PUTqDzJMQ.jpg Découvrez comment les 22 règles de l'annexe VIII fixent les classes sous le MDR de l'UE et comment appliquer la règle la plus stricte. https://stream.mux.com/E67JA1rg012v0002bCwrk6gZzbkcuT8EyFB19PUTqDzJMQ.m3u8 https://player.mux.com/E67JA1rg012v0002bCwrk6gZzbkcuT8EyFB19PUTqDzJMQ?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FE67JA1rg012v0002bCwrk6gZzbkcuT8EyFB19PUTqDzJMQ.jpg&accent-color=%232451c6 108 2026-10-16T04:59:27.006Z 2026-10-15 https://www.pureglobal.com/fr/markets/european-union/eu-mdr-consulting/eu-mdr-clinical-evaluation-reports-cer-for-medical-devices EU MDR : rapports d'évaluation clinique https://www.pureglobal.com/assets/video-posters/teVFqOlFbuce01lKbdwr2d013lyRTQYKcsR7apvEpQMTI.jpg Introduction au rapport d'évaluation clinique sous le MDR de l'UE, exigences de preuves et mise à jour continue du CER. https://stream.mux.com/teVFqOlFbuce01lKbdwr2d013lyRTQYKcsR7apvEpQMTI.m3u8 https://player.mux.com/teVFqOlFbuce01lKbdwr2d013lyRTQYKcsR7apvEpQMTI?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FteVFqOlFbuce01lKbdwr2d013lyRTQYKcsR7apvEpQMTI.jpg&accent-color=%232451c6 110 2026-10-16T04:59:53.863Z 2026-10-15 https://www.pureglobal.com/fr/markets/european-union/eu-mdr-consulting/eu-pmcf-post-market-clinical-follow-up-for-medical-devices EU MDR PMCF : plans, rapports et calendrier https://www.pureglobal.com/assets/video-posters/MeeXg9C003BX00JkwSbbc1wtufRkp7btq3ZAbd1NDSxlo.jpg Guide sur le suivi clinique après commercialisation (PMCF) sous le MDR de l'UE, incluant les plans PMCF, rapports d'évaluation et calendrier. https://stream.mux.com/MeeXg9C003BX00JkwSbbc1wtufRkp7btq3ZAbd1NDSxlo.m3u8 https://player.mux.com/MeeXg9C003BX00JkwSbbc1wtufRkp7btq3ZAbd1NDSxlo?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FMeeXg9C003BX00JkwSbbc1wtufRkp7btq3ZAbd1NDSxlo.jpg&accent-color=%232451c6 108 2026-10-16T04:58:54.123Z 2026-10-15 https://www.pureglobal.com/fr/markets/european-union/eu-mdr-gspr-checklist-annex-i 2026-10-15 https://www.pureglobal.com/fr/markets/european-union/eu-mdr-ivdr-person-responsible-for-regulatory-compliance-prrc PRRC UE : exigences de l'article 15 https://www.pureglobal.com/assets/video-posters/NcCR00V8nB5wmFTN7C1kJTBAa7Kmlmfi02ee7XwsMyuQM.jpg Comprenez le rôle de la PRRC selon l'article 15 du MDR et de l'IVDR, y compris les qualifications et responsabilités. https://stream.mux.com/NcCR00V8nB5wmFTN7C1kJTBAa7Kmlmfi02ee7XwsMyuQM.m3u8 https://player.mux.com/NcCR00V8nB5wmFTN7C1kJTBAa7Kmlmfi02ee7XwsMyuQM?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FNcCR00V8nB5wmFTN7C1kJTBAa7Kmlmfi02ee7XwsMyuQM.jpg&accent-color=%232451c6 108 2026-10-16T04:59:34.224Z 2026-10-15 https://www.pureglobal.com/fr/markets/european-union/eu-mdr-psur-periodic-safety-update-report 2026-10-15 https://www.pureglobal.com/fr/markets/european-union/eudamed-medical-device-ivd-registration 2026-10-15 https://www.pureglobal.com/fr/markets/european-union/mdr-and-ivdr-postmarket-surveillance 2026-10-15 https://www.pureglobal.com/fr/markets/hong-kong MDACS Hong Kong : inscription volontaire https://www.pureglobal.com/assets/video-posters/01g3xtsRTru7Ig7A01vNe023Nr38jopQLEqTx6KLhqJ8RQ.jpg Découvrez le cadre d'inscription MDACS de Hong Kong, la CMPR et les changements abordés dans cette vidéo. https://stream.mux.com/01g3xtsRTru7Ig7A01vNe023Nr38jopQLEqTx6KLhqJ8RQ.m3u8 https://player.mux.com/01g3xtsRTru7Ig7A01vNe023Nr38jopQLEqTx6KLhqJ8RQ?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F01g3xtsRTru7Ig7A01vNe023Nr38jopQLEqTx6KLhqJ8RQ.jpg&accent-color=%232451c6 101 2026-10-16T04:59:15.866Z 2026-10-15 https://www.pureglobal.com/fr/markets/india 2026-10-15 https://www.pureglobal.com/fr/markets/indonesia 2026-10-15 https://www.pureglobal.com/fr/markets/indonesia/medical-device-classification 2026-10-15 https://www.pureglobal.com/fr/markets/indonesia/medical-device-labeling 2026-10-15 https://www.pureglobal.com/fr/markets/indonesia/medical-device-postmarket-requirements 2026-10-15 https://www.pureglobal.com/fr/markets/indonesia/medical-device-regulations 2026-10-15 https://www.pureglobal.com/fr/markets/israel 2026-10-15 https://www.pureglobal.com/fr/markets/japan 2026-10-15 https://www.pureglobal.com/fr/markets/japan/marketing-authorization-holder-mah-dmah 2026-10-15 https://www.pureglobal.com/fr/markets/macau 2026-10-15 https://www.pureglobal.com/fr/markets/malaysia 2026-10-15 https://www.pureglobal.com/fr/markets/malaysia/mda-medical-device-classification 2026-10-15 https://www.pureglobal.com/fr/markets/malaysia/mda-medical-device-labeling 2026-10-15 https://www.pureglobal.com/fr/markets/malaysia/mda-medical-device-postmarket-requirements 2026-10-15 https://www.pureglobal.com/fr/markets/malaysia/mda-medical-device-regulations 2026-10-15 https://www.pureglobal.com/fr/markets/mexico 2026-10-15 https://www.pureglobal.com/fr/markets/mexico/cofepris-medical-device-and-ivd-classification 2026-10-15 https://www.pureglobal.com/fr/markets/mexico/cofepris-medical-device-labeling 2026-10-15 https://www.pureglobal.com/fr/markets/mexico/cofepris-medical-device-postmarket-compliance 2026-10-15 https://www.pureglobal.com/fr/markets/mexico/cofepris-medical-device-regulations 2026-10-15 https://www.pureglobal.com/fr/markets/new-zealand 2026-10-15 https://www.pureglobal.com/fr/markets/pakistan 2026-10-15 https://www.pureglobal.com/fr/markets/peru Pérou DIGEMID : délais et frais de dossier https://www.pureglobal.com/assets/video-posters/PgJluzdF01VY00Yazash8pKwFUhg8w02jyHeCw02sjh1VPM.jpg Découvrez les voies d'enregistrement des dispositifs médicaux au Pérou ainsi que les délais d'examen et frais de la DIGEMID. https://stream.mux.com/PgJluzdF01VY00Yazash8pKwFUhg8w02jyHeCw02sjh1VPM.m3u8 https://player.mux.com/PgJluzdF01VY00Yazash8pKwFUhg8w02jyHeCw02sjh1VPM?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FPgJluzdF01VY00Yazash8pKwFUhg8w02jyHeCw02sjh1VPM.jpg&accent-color=%232451c6 109 2026-10-16T05:00:08.644Z 2026-10-15 https://www.pureglobal.com/fr/markets/philippines Philippines FDA : CMDN ou CMDR ? https://www.pureglobal.com/assets/video-posters/Hfkt6CXufVLkbOFBferCDgsxd0101j3BPO5R5ZQhxIdhU.jpg Comprenez les voies CMDN et CMDR de FDA aux Philippines et les évolutions d'enregistrement abordées dans cette vidéo. https://stream.mux.com/Hfkt6CXufVLkbOFBferCDgsxd0101j3BPO5R5ZQhxIdhU.m3u8 https://player.mux.com/Hfkt6CXufVLkbOFBferCDgsxd0101j3BPO5R5ZQhxIdhU?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FHfkt6CXufVLkbOFBferCDgsxd0101j3BPO5R5ZQhxIdhU.jpg&accent-color=%232451c6 114 2026-10-16T04:59:00.292Z 2026-10-15 https://www.pureglobal.com/fr/markets/saudi-arabia 2026-10-15 https://www.pureglobal.com/fr/markets/singapore 2026-10-15 https://www.pureglobal.com/fr/markets/singapore/hsa-medical-device-classification 2026-10-15 https://www.pureglobal.com/fr/markets/singapore/hsa-medical-device-labeling 2026-10-15 https://www.pureglobal.com/fr/markets/singapore/hsa-medical-device-postmarket-surveillance 2026-10-15 https://www.pureglobal.com/fr/markets/singapore/hsa-medical-device-regulations 2026-10-15 https://www.pureglobal.com/fr/markets/south-korea Corée du Sud MFDS : enregistrement DM https://www.pureglobal.com/assets/video-posters/tRBfiLaVikYUQunZna7jnZgQOb81jfyeEhsQO78haX8.jpg Découvrez les classes de dispositifs en Corée du Sud, les voies d'enregistrement MFDS, les délais et le renouvellement à 5 ans. https://stream.mux.com/tRBfiLaVikYUQunZna7jnZgQOb81jfyeEhsQO78haX8.m3u8 https://player.mux.com/tRBfiLaVikYUQunZna7jnZgQOb81jfyeEhsQO78haX8?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FtRBfiLaVikYUQunZna7jnZgQOb81jfyeEhsQO78haX8.jpg&accent-color=%232451c6 104 2026-10-16T04:59:57.021Z 2026-10-15 https://www.pureglobal.com/fr/markets/switzerland 2026-10-15 https://www.pureglobal.com/fr/markets/taiwan 2026-10-15 https://www.pureglobal.com/fr/markets/thailand 2026-10-15 https://www.pureglobal.com/fr/markets/thailand/thailand-medical-device-and-ivd-classification 2026-10-15 https://www.pureglobal.com/fr/markets/thailand/thailand-medical-device-and-ivd-labeling-requirements 2026-10-15 https://www.pureglobal.com/fr/markets/thailand/thailand-medical-device-and-ivd-regulations 2026-10-15 https://www.pureglobal.com/fr/markets/thailand/thailand-medical-device-post-market-requirements 2026-10-15 https://www.pureglobal.com/fr/markets/uae 2026-10-15 https://www.pureglobal.com/fr/markets/united-kingdom 2026-10-15 https://www.pureglobal.com/fr/markets/united-kingdom/uk-responsible-person-medical-devices 2026-10-15 https://www.pureglobal.com/fr/markets/united-states 2026-10-15 https://www.pureglobal.com/fr/markets/united-states/fda-21-cfr-part-801-medical-device-labeling-and-iso-15223-symbols 2026-10-15 https://www.pureglobal.com/fr/markets/united-states/fda-483-and-warning-letter-response-and-consulting FDA Form 483 : réponses et lettres d'avertissement https://www.pureglobal.com/assets/video-posters/binE4h84L7wmSv6V9M9p75OaUNQkD8H6oRA2pfQ4YYM.jpg Comprenez les observations du Formulaire 483, les délais de réponse, lettres d'avertissement et bilans d'inspection de FDA. https://stream.mux.com/binE4h84L7wmSv6V9M9p75OaUNQkD8H6oRA2pfQ4YYM.m3u8 https://player.mux.com/binE4h84L7wmSv6V9M9p75OaUNQkD8H6oRA2pfQ4YYM?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FbinE4h84L7wmSv6V9M9p75OaUNQkD8H6oRA2pfQ4YYM.jpg&accent-color=%232451c6 108 2026-10-16T04:57:51.770Z 2026-10-15 https://www.pureglobal.com/fr/markets/united-states/fda-biocompatibility-iso-10993-evaluation-guide 2026-10-15 https://www.pureglobal.com/fr/markets/united-states/fda-certificate-to-foreign-government-cfg-for-medical-devices FDA CFG : certificats d'export de DM https://www.pureglobal.com/assets/video-posters/fS276ccoWXokDxwtDforbRhDHmMWdtaxx67gerBBBeE.jpg Découvrez ce que couvre le Certificate to Foreign Government de FDA, quand les exportateurs en ont besoin et comment le demander. https://stream.mux.com/fS276ccoWXokDxwtDforbRhDHmMWdtaxx67gerBBBeE.m3u8 https://player.mux.com/fS276ccoWXokDxwtDforbRhDHmMWdtaxx67gerBBBeE?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FfS276ccoWXokDxwtDforbRhDHmMWdtaxx67gerBBBeE.jpg&accent-color=%232451c6 107 2026-10-16T04:58:42.168Z 2026-10-15 https://www.pureglobal.com/fr/markets/united-states/fda-de-novo-classification-request 2026-10-15 https://www.pureglobal.com/fr/markets/united-states/fda-estar-submission-template-guide 2026-10-15 https://www.pureglobal.com/fr/markets/united-states/fda-ide-and-breakthrough-device-designation-guide 2026-10-15 https://www.pureglobal.com/fr/markets/united-states/fda-medical-device-reporting-mdr-consulting FDA MDR : déclaration des incidents https://www.pureglobal.com/assets/video-posters/AkU7r439f004ndRky18ENwIzhgrzkb28GCKrfrReVjYM.jpg Aperçu du 21 CFR 803, des délais de déclaration des dispositifs, rapports à 5 jours et soumissions MDR électroniques. https://stream.mux.com/AkU7r439f004ndRky18ENwIzhgrzkb28GCKrfrReVjYM.m3u8 https://player.mux.com/AkU7r439f004ndRky18ENwIzhgrzkb28GCKrfrReVjYM?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FAkU7r439f004ndRky18ENwIzhgrzkb28GCKrfrReVjYM.jpg&accent-color=%232451c6 109 2026-10-16T04:58:11.613Z 2026-10-15 https://www.pureglobal.com/fr/markets/united-states/fda-pre-sub-guidance-and-q-sub-guidance-for-medical-devices Pre-Sub FDA : processus Q-Submission https://www.pureglobal.com/assets/video-posters/be1w25SmygP8Eg02Vh3JuxdRmF8LXQyxZRgtgWwy01YUI.jpg Comprenez les réunions Pre-Sub FDA, les types de Q-Submission, les délais et comment préparer des questions ciblées. https://stream.mux.com/be1w25SmygP8Eg02Vh3JuxdRmF8LXQyxZRgtgWwy01YUI.m3u8 https://player.mux.com/be1w25SmygP8Eg02Vh3JuxdRmF8LXQyxZRgtgWwy01YUI?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2Fbe1w25SmygP8Eg02Vh3JuxdRmF8LXQyxZRgtgWwy01YUI.jpg&accent-color=%232451c6 105 2026-10-16T04:58:29.478Z 2026-10-15 https://www.pureglobal.com/fr/markets/united-states/fda-premarket-approval-pma-submission-consulting-for-medical-devices FDA PMA : approbation expliquée https://www.pureglobal.com/assets/video-posters/WEZQpF8YhdddbBNLteXLBkpxiekr4EqDJD39okgMqKg.jpg Découvrez quand un dispositif requiert l'approbation préalable FDA et comment s'articulent preuves PMA, frais et délais d'examen. https://stream.mux.com/WEZQpF8YhdddbBNLteXLBkpxiekr4EqDJD39okgMqKg.m3u8 https://player.mux.com/WEZQpF8YhdddbBNLteXLBkpxiekr4EqDJD39okgMqKg?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FWEZQpF8YhdddbBNLteXLBkpxiekr4EqDJD39okgMqKg.jpg&accent-color=%232451c6 105 2026-10-16T04:59:06.512Z 2026-10-15 https://www.pureglobal.com/fr/markets/united-states/fda-recognized-consensus-standards-and-doc-guide 2026-10-15 https://www.pureglobal.com/fr/markets/united-states/fda-udi-and-gudid-database-submission-guide 2026-10-15 https://www.pureglobal.com/fr/markets/united-states/us-fda-510k-clearance-submission-consulting FDA 510(k) : autorisation et soumission https://www.pureglobal.com/assets/video-posters/9eLZMqKyqjKGI02yLiOYiSg9QwaewYbYkd2NVn00ZZJxg.jpg Découvrez l'équivalence substantielle, les prédicats, eSTAR et les frais de soumission FDA 510(k) abordés dans cette vidéo. https://stream.mux.com/9eLZMqKyqjKGI02yLiOYiSg9QwaewYbYkd2NVn00ZZJxg.m3u8 https://player.mux.com/9eLZMqKyqjKGI02yLiOYiSg9QwaewYbYkd2NVn00ZZJxg?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F9eLZMqKyqjKGI02yLiOYiSg9QwaewYbYkd2NVn00ZZJxg.jpg&accent-color=%232451c6 111 2026-10-16T04:58:34.086Z 2026-10-15 https://www.pureglobal.com/fr/markets/united-states/us-fda-agent-for-medical-devices-companies 2026-10-15 https://www.pureglobal.com/fr/markets/united-states/us-fda-medical-device-and-ivd-classification-consulting 2026-10-15 https://www.pureglobal.com/fr/markets/united-states/us-fda-medical-device-establishment-registration-and-device-listing 2026-10-15 https://www.pureglobal.com/fr/markets/united-states/us-fda-qmsr-consulting-for-medical-devices 2026-10-15 https://www.pureglobal.com/fr/markets/vietnam 2026-10-15 https://www.pureglobal.com/fr/markets/vietnam/vietnam-medical-device-and-ivd-classification-and-grouping 2026-10-15 https://www.pureglobal.com/fr/markets/vietnam/vietnam-medical-device-and-ivd-post-market-requirements 2026-10-15 https://www.pureglobal.com/fr/markets/vietnam/vietnam-medical-device-and-ivd-regulations 2026-10-15 https://www.pureglobal.com/fr/markets/vietnam/vietnam-medical-device-labeling-requirements 2026-10-15 https://www.pureglobal.com/it/markets 2026-06-17 https://www.pureglobal.com/it/markets/argentina 2026-10-15 https://www.pureglobal.com/it/markets/australia 2026-10-15 https://www.pureglobal.com/it/markets/australia/artg-sponsor-manufacturer-evidence 2026-10-15 https://www.pureglobal.com/it/markets/bangladesh 2026-10-15 https://www.pureglobal.com/it/markets/brazil 2026-10-15 https://www.pureglobal.com/it/markets/brazil/ai-brazil-anvisa-submissions 2026-10-15 https://www.pureglobal.com/it/markets/brazil/anvisa-medical-device-classification 2026-10-15 https://www.pureglobal.com/it/markets/brazil/anvisa-medical-device-labeling 2026-10-15 https://www.pureglobal.com/it/markets/brazil/anvisa-medical-device-postmarket-surveillance 2026-10-15 https://www.pureglobal.com/it/markets/brazil/anvisa-medical-device-regulations 2026-10-15 https://www.pureglobal.com/it/markets/brazil/inmetro-anatel-medical-device-certification 2026-10-15 https://www.pureglobal.com/it/markets/canada 2026-10-15 https://www.pureglobal.com/it/markets/canada/medical-device-licence-mdl-vs-mdel 2026-10-15 https://www.pureglobal.com/it/markets/china Cina NMPA: registrazione dispositivi https://www.pureglobal.com/assets/video-posters/Py5Uz9dIR02qXfIy7796D02yWaXwfVtG023CqZO2CL02gE00.jpg Videoguida a classi di dispositivi NMPA, percorsi di registrazione, tempi di riesame e quadro GMP cinese sui dispositivi. https://stream.mux.com/Py5Uz9dIR02qXfIy7796D02yWaXwfVtG023CqZO2CL02gE00.m3u8 https://player.mux.com/Py5Uz9dIR02qXfIy7796D02yWaXwfVtG023CqZO2CL02gE00?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FPy5Uz9dIR02qXfIy7796D02yWaXwfVtG023CqZO2CL02gE00.jpg&accent-color=%232451c6 115 2026-10-16T04:59:21.203Z 2026-10-15 https://www.pureglobal.com/it/markets/colombia 2026-10-15 https://www.pureglobal.com/it/markets/colombia/invima-medical-device-classification 2026-10-15 https://www.pureglobal.com/it/markets/colombia/invima-medical-device-labeling 2026-10-15 https://www.pureglobal.com/it/markets/colombia/invima-medical-device-postmarket-compliance 2026-10-15 https://www.pureglobal.com/it/markets/colombia/invima-medical-device-regulations 2026-10-15 https://www.pureglobal.com/it/markets/costa-rica 2026-10-15 https://www.pureglobal.com/it/markets/egypt 2026-10-15 https://www.pureglobal.com/it/markets/european-union 2026-10-15 https://www.pureglobal.com/it/markets/european-union/ce-mark-notified-body-search EU MDR: scelta di un organismo notificato https://www.pureglobal.com/assets/video-posters/hm5Pl53mUXV00dpBZdTCSQ02AnNlLWYnTs2PIbnOEbGO00.jpg Scopri come usare NANDO per verificare designazione e scopo di un organismo notificato per il tuo dispositivo secondo l'EU MDR. https://stream.mux.com/hm5Pl53mUXV00dpBZdTCSQ02AnNlLWYnTs2PIbnOEbGO00.m3u8 https://player.mux.com/hm5Pl53mUXV00dpBZdTCSQ02AnNlLWYnTs2PIbnOEbGO00?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2Fhm5Pl53mUXV00dpBZdTCSQ02AnNlLWYnTs2PIbnOEbGO00.jpg&accent-color=%232451c6 104 2026-10-16T04:58:47.608Z 2026-10-15 https://www.pureglobal.com/it/markets/european-union/ec-european-authorized-representative Mandatari UE: Articolo 11 https://www.pureglobal.com/assets/video-posters/8f2diZEFPEGBYwbxgEpcIL81gUNdow1kmcCTRB00WES4.jpg Scopri quando è necessario un mandatario UE e quali sono i requisiti dell'Articolo 11 di MDR e IVDR. https://stream.mux.com/8f2diZEFPEGBYwbxgEpcIL81gUNdow1kmcCTRB00WES4.m3u8 https://player.mux.com/8f2diZEFPEGBYwbxgEpcIL81gUNdow1kmcCTRB00WES4?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F8f2diZEFPEGBYwbxgEpcIL81gUNdow1kmcCTRB00WES4.jpg&accent-color=%232451c6 100 2026-10-16T04:59:45.925Z 2026-10-15 https://www.pureglobal.com/it/markets/european-union/eu-ivdr-consulting 2026-10-15 https://www.pureglobal.com/it/markets/european-union/eu-ivdr-consulting/ce-marking-approval-for-ivds 2026-10-15 https://www.pureglobal.com/it/markets/european-union/eu-ivdr-consulting/ivdr-classification IVDR: classi A–D e scadenze di transizione https://www.pureglobal.com/assets/video-posters/xFfNtUAJbK9nQD6IlZ41k13i47i2GVxwTtp2JBBYoVA.jpg Esplora la classificazione IVDR, le regole dell'Allegato VIII e le scadenze di transizione per gli IVD legacy illustrate nel video. https://stream.mux.com/xFfNtUAJbK9nQD6IlZ41k13i47i2GVxwTtp2JBBYoVA.m3u8 https://player.mux.com/xFfNtUAJbK9nQD6IlZ41k13i47i2GVxwTtp2JBBYoVA?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FxFfNtUAJbK9nQD6IlZ41k13i47i2GVxwTtp2JBBYoVA.jpg&accent-color=%232451c6 117 2026-10-16T04:59:40.284Z 2026-10-15 https://www.pureglobal.com/it/markets/european-union/eu-ivdr-consulting/ivdr-per-performance-evaluation-report 2026-10-15 https://www.pureglobal.com/it/markets/european-union/eu-ivdr-consulting/pmpf-postmarket-performance 2026-10-15 https://www.pureglobal.com/it/markets/european-union/eu-mdr-consulting 2026-10-15 https://www.pureglobal.com/it/markets/european-union/eu-mdr-consulting/eu-mdr-ce-marking-approval-for-medical-devices 2026-10-15 https://www.pureglobal.com/it/markets/european-union/eu-mdr-consulting/eu-mdr-classification-for-medical-devices EU MDR: regole di classificazione dei dispositivi https://www.pureglobal.com/assets/video-posters/E67JA1rg012v0002bCwrk6gZzbkcuT8EyFB19PUTqDzJMQ.jpg Scopri come le 22 regole dell'Allegato VIII determinano le classi dei dispositivi EU MDR e come applicare la regola più rigorosa. https://stream.mux.com/E67JA1rg012v0002bCwrk6gZzbkcuT8EyFB19PUTqDzJMQ.m3u8 https://player.mux.com/E67JA1rg012v0002bCwrk6gZzbkcuT8EyFB19PUTqDzJMQ?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FE67JA1rg012v0002bCwrk6gZzbkcuT8EyFB19PUTqDzJMQ.jpg&accent-color=%232451c6 108 2026-10-16T04:59:27.006Z 2026-10-15 https://www.pureglobal.com/it/markets/european-union/eu-mdr-consulting/eu-mdr-clinical-evaluation-reports-cer-for-medical-devices EU MDR: relazioni di valutazione clinica https://www.pureglobal.com/assets/video-posters/teVFqOlFbuce01lKbdwr2d013lyRTQYKcsR7apvEpQMTI.jpg Introduzione alla relazione di valutazione clinica EU MDR, ai requisiti sulle evidenze e all'aggiornamento continuo del CER. https://stream.mux.com/teVFqOlFbuce01lKbdwr2d013lyRTQYKcsR7apvEpQMTI.m3u8 https://player.mux.com/teVFqOlFbuce01lKbdwr2d013lyRTQYKcsR7apvEpQMTI?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FteVFqOlFbuce01lKbdwr2d013lyRTQYKcsR7apvEpQMTI.jpg&accent-color=%232451c6 110 2026-10-16T04:59:53.863Z 2026-10-15 https://www.pureglobal.com/it/markets/european-union/eu-mdr-consulting/eu-pmcf-post-market-clinical-follow-up-for-medical-devices EU MDR PMCF: piani, relazioni e tempistiche https://www.pureglobal.com/assets/video-posters/MeeXg9C003BX00JkwSbbc1wtufRkp7btq3ZAbd1NDSxlo.jpg Guida al follow-up clinico post-commercializzazione secondo l'EU MDR, inclusi piani PMCF, relazioni di valutazione e tempistiche. https://stream.mux.com/MeeXg9C003BX00JkwSbbc1wtufRkp7btq3ZAbd1NDSxlo.m3u8 https://player.mux.com/MeeXg9C003BX00JkwSbbc1wtufRkp7btq3ZAbd1NDSxlo?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FMeeXg9C003BX00JkwSbbc1wtufRkp7btq3ZAbd1NDSxlo.jpg&accent-color=%232451c6 108 2026-10-16T04:58:54.123Z 2026-10-15 https://www.pureglobal.com/it/markets/european-union/eu-mdr-gspr-checklist-annex-i 2026-10-15 https://www.pureglobal.com/it/markets/european-union/eu-mdr-ivdr-person-responsible-for-regulatory-compliance-prrc EU PRRC: requisiti dell'Articolo 15 https://www.pureglobal.com/assets/video-posters/NcCR00V8nB5wmFTN7C1kJTBAa7Kmlmfi02ee7XwsMyuQM.jpg Comprendi il ruolo del PRRC ai sensi dell'Articolo 15 di MDR e IVDR, inclusi requisiti di qualifica e responsabilità. https://stream.mux.com/NcCR00V8nB5wmFTN7C1kJTBAa7Kmlmfi02ee7XwsMyuQM.m3u8 https://player.mux.com/NcCR00V8nB5wmFTN7C1kJTBAa7Kmlmfi02ee7XwsMyuQM?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FNcCR00V8nB5wmFTN7C1kJTBAa7Kmlmfi02ee7XwsMyuQM.jpg&accent-color=%232451c6 108 2026-10-16T04:59:34.224Z 2026-10-15 https://www.pureglobal.com/it/markets/european-union/eu-mdr-psur-periodic-safety-update-report 2026-10-15 https://www.pureglobal.com/it/markets/european-union/eudamed-medical-device-ivd-registration 2026-10-15 https://www.pureglobal.com/it/markets/european-union/mdr-and-ivdr-postmarket-surveillance 2026-10-15 https://www.pureglobal.com/it/markets/hong-kong Hong Kong MDACS: inserimento volontario in elenco https://www.pureglobal.com/assets/video-posters/01g3xtsRTru7Ig7A01vNe023Nr38jopQLEqTx6KLhqJ8RQ.jpg Esplora il quadro di listing MDACS di Hong Kong, il CMPR e le novità trattate in questo video. https://stream.mux.com/01g3xtsRTru7Ig7A01vNe023Nr38jopQLEqTx6KLhqJ8RQ.m3u8 https://player.mux.com/01g3xtsRTru7Ig7A01vNe023Nr38jopQLEqTx6KLhqJ8RQ?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F01g3xtsRTru7Ig7A01vNe023Nr38jopQLEqTx6KLhqJ8RQ.jpg&accent-color=%232451c6 101 2026-10-16T04:59:15.866Z 2026-10-15 https://www.pureglobal.com/it/markets/india 2026-10-15 https://www.pureglobal.com/it/markets/indonesia 2026-10-15 https://www.pureglobal.com/it/markets/indonesia/medical-device-classification 2026-10-15 https://www.pureglobal.com/it/markets/indonesia/medical-device-labeling 2026-10-15 https://www.pureglobal.com/it/markets/indonesia/medical-device-postmarket-requirements 2026-10-15 https://www.pureglobal.com/it/markets/indonesia/medical-device-regulations 2026-10-15 https://www.pureglobal.com/it/markets/israel 2026-10-15 https://www.pureglobal.com/it/markets/japan 2026-10-15 https://www.pureglobal.com/it/markets/japan/marketing-authorization-holder-mah-dmah 2026-10-15 https://www.pureglobal.com/it/markets/macau 2026-10-15 https://www.pureglobal.com/it/markets/malaysia 2026-10-15 https://www.pureglobal.com/it/markets/malaysia/mda-medical-device-classification 2026-10-15 https://www.pureglobal.com/it/markets/malaysia/mda-medical-device-labeling 2026-10-15 https://www.pureglobal.com/it/markets/malaysia/mda-medical-device-postmarket-requirements 2026-10-15 https://www.pureglobal.com/it/markets/malaysia/mda-medical-device-regulations 2026-10-15 https://www.pureglobal.com/it/markets/mexico 2026-10-15 https://www.pureglobal.com/it/markets/mexico/cofepris-medical-device-and-ivd-classification 2026-10-15 https://www.pureglobal.com/it/markets/mexico/cofepris-medical-device-labeling 2026-10-15 https://www.pureglobal.com/it/markets/mexico/cofepris-medical-device-postmarket-compliance 2026-10-15 https://www.pureglobal.com/it/markets/mexico/cofepris-medical-device-regulations 2026-10-15 https://www.pureglobal.com/it/markets/new-zealand 2026-10-15 https://www.pureglobal.com/it/markets/pakistan 2026-10-15 https://www.pureglobal.com/it/markets/peru Perù DIGEMID: tempi e tariffe di registrazione https://www.pureglobal.com/assets/video-posters/PgJluzdF01VY00Yazash8pKwFUhg8w02jyHeCw02sjh1VPM.jpg Scopri i percorsi di registrazione dei dispositivi medici in Perù, i tempi di valutazione DIGEMID e le relative tariffe nel video. https://stream.mux.com/PgJluzdF01VY00Yazash8pKwFUhg8w02jyHeCw02sjh1VPM.m3u8 https://player.mux.com/PgJluzdF01VY00Yazash8pKwFUhg8w02jyHeCw02sjh1VPM?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FPgJluzdF01VY00Yazash8pKwFUhg8w02jyHeCw02sjh1VPM.jpg&accent-color=%232451c6 109 2026-10-16T05:00:08.644Z 2026-10-15 https://www.pureglobal.com/it/markets/philippines Filippine FDA: CMDN o CMDR? https://www.pureglobal.com/assets/video-posters/Hfkt6CXufVLkbOFBferCDgsxd0101j3BPO5R5ZQhxIdhU.jpg Comprendi i percorsi CMDN e CMDR della FDA filippina e le novità di registrazione trattate nel video. https://stream.mux.com/Hfkt6CXufVLkbOFBferCDgsxd0101j3BPO5R5ZQhxIdhU.m3u8 https://player.mux.com/Hfkt6CXufVLkbOFBferCDgsxd0101j3BPO5R5ZQhxIdhU?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FHfkt6CXufVLkbOFBferCDgsxd0101j3BPO5R5ZQhxIdhU.jpg&accent-color=%232451c6 114 2026-10-16T04:59:00.292Z 2026-10-15 https://www.pureglobal.com/it/markets/saudi-arabia 2026-10-15 https://www.pureglobal.com/it/markets/singapore 2026-10-15 https://www.pureglobal.com/it/markets/singapore/hsa-medical-device-classification 2026-10-15 https://www.pureglobal.com/it/markets/singapore/hsa-medical-device-labeling 2026-10-15 https://www.pureglobal.com/it/markets/singapore/hsa-medical-device-postmarket-surveillance 2026-10-15 https://www.pureglobal.com/it/markets/singapore/hsa-medical-device-regulations 2026-10-15 https://www.pureglobal.com/it/markets/south-korea Corea del Sud MFDS: registrazione dispositivi https://www.pureglobal.com/assets/video-posters/tRBfiLaVikYUQunZna7jnZgQOb81jfyeEhsQO78haX8.jpg Esplora le classi di dispositivi in Corea del Sud, i percorsi di registrazione MFDS, i tempi di esame e il rinnovo quinquennale. https://stream.mux.com/tRBfiLaVikYUQunZna7jnZgQOb81jfyeEhsQO78haX8.m3u8 https://player.mux.com/tRBfiLaVikYUQunZna7jnZgQOb81jfyeEhsQO78haX8?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FtRBfiLaVikYUQunZna7jnZgQOb81jfyeEhsQO78haX8.jpg&accent-color=%232451c6 104 2026-10-16T04:59:57.021Z 2026-10-15 https://www.pureglobal.com/it/markets/switzerland 2026-10-15 https://www.pureglobal.com/it/markets/taiwan 2026-10-15 https://www.pureglobal.com/it/markets/thailand 2026-10-15 https://www.pureglobal.com/it/markets/thailand/thailand-medical-device-and-ivd-classification 2026-10-15 https://www.pureglobal.com/it/markets/thailand/thailand-medical-device-and-ivd-labeling-requirements 2026-10-15 https://www.pureglobal.com/it/markets/thailand/thailand-medical-device-and-ivd-regulations 2026-10-15 https://www.pureglobal.com/it/markets/thailand/thailand-medical-device-post-market-requirements 2026-10-15 https://www.pureglobal.com/it/markets/uae 2026-10-15 https://www.pureglobal.com/it/markets/united-kingdom 2026-10-15 https://www.pureglobal.com/it/markets/united-kingdom/uk-responsible-person-medical-devices 2026-10-15 https://www.pureglobal.com/it/markets/united-states 2026-10-15 https://www.pureglobal.com/it/markets/united-states/fda-21-cfr-part-801-medical-device-labeling-and-iso-15223-symbols 2026-10-15 https://www.pureglobal.com/it/markets/united-states/fda-483-and-warning-letter-response-and-consulting FDA Form 483: risposte e Warning Letter https://www.pureglobal.com/assets/video-posters/binE4h84L7wmSv6V9M9p75OaUNQkD8H6oRA2pfQ4YYM.jpg Comprendi le osservazioni del Form 483, i tempi di risposta, le warning letter e gli esiti delle ispezioni FDA. https://stream.mux.com/binE4h84L7wmSv6V9M9p75OaUNQkD8H6oRA2pfQ4YYM.m3u8 https://player.mux.com/binE4h84L7wmSv6V9M9p75OaUNQkD8H6oRA2pfQ4YYM?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FbinE4h84L7wmSv6V9M9p75OaUNQkD8H6oRA2pfQ4YYM.jpg&accent-color=%232451c6 108 2026-10-16T04:57:51.770Z 2026-10-15 https://www.pureglobal.com/it/markets/united-states/fda-biocompatibility-iso-10993-evaluation-guide 2026-10-15 https://www.pureglobal.com/it/markets/united-states/fda-certificate-to-foreign-government-cfg-for-medical-devices FDA CFG: certificati per l'esportazione https://www.pureglobal.com/assets/video-posters/fS276ccoWXokDxwtDforbRhDHmMWdtaxx67gerBBBeE.jpg Scopri cosa copre un Certificate to Foreign Government FDA, quando serve agli esportatori e come funzionano le richieste. https://stream.mux.com/fS276ccoWXokDxwtDforbRhDHmMWdtaxx67gerBBBeE.m3u8 https://player.mux.com/fS276ccoWXokDxwtDforbRhDHmMWdtaxx67gerBBBeE?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FfS276ccoWXokDxwtDforbRhDHmMWdtaxx67gerBBBeE.jpg&accent-color=%232451c6 107 2026-10-16T04:58:42.168Z 2026-10-15 https://www.pureglobal.com/it/markets/united-states/fda-de-novo-classification-request 2026-10-15 https://www.pureglobal.com/it/markets/united-states/fda-estar-submission-template-guide 2026-10-15 https://www.pureglobal.com/it/markets/united-states/fda-ide-and-breakthrough-device-designation-guide 2026-10-15 https://www.pureglobal.com/it/markets/united-states/fda-medical-device-reporting-mdr-consulting FDA MDR: segnalazione dispositivi medici https://www.pureglobal.com/assets/video-posters/AkU7r439f004ndRky18ENwIzhgrzkb28GCKrfrReVjYM.jpg Panoramica su 21 CFR 803, scadenze di segnalazione dei dispositivi medici, report a 5 giorni e invii elettronici MDR. https://stream.mux.com/AkU7r439f004ndRky18ENwIzhgrzkb28GCKrfrReVjYM.m3u8 https://player.mux.com/AkU7r439f004ndRky18ENwIzhgrzkb28GCKrfrReVjYM?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FAkU7r439f004ndRky18ENwIzhgrzkb28GCKrfrReVjYM.jpg&accent-color=%232451c6 109 2026-10-16T04:58:11.613Z 2026-10-15 https://www.pureglobal.com/it/markets/united-states/fda-pre-sub-guidance-and-q-sub-guidance-for-medical-devices FDA Pre-Sub: il processo Q-Submission https://www.pureglobal.com/assets/video-posters/be1w25SmygP8Eg02Vh3JuxdRmF8LXQyxZRgtgWwy01YUI.jpg Comprendi i meeting Pre-Sub con FDA, i tipi di Q-Submission, le tempistiche e come preparare quesiti mirati. https://stream.mux.com/be1w25SmygP8Eg02Vh3JuxdRmF8LXQyxZRgtgWwy01YUI.m3u8 https://player.mux.com/be1w25SmygP8Eg02Vh3JuxdRmF8LXQyxZRgtgWwy01YUI?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2Fbe1w25SmygP8Eg02Vh3JuxdRmF8LXQyxZRgtgWwy01YUI.jpg&accent-color=%232451c6 105 2026-10-16T04:58:29.478Z 2026-10-15 https://www.pureglobal.com/it/markets/united-states/fda-premarket-approval-pma-submission-consulting-for-medical-devices FDA PMA: approvazione pre-market https://www.pureglobal.com/assets/video-posters/WEZQpF8YhdddbBNLteXLBkpxiekr4EqDJD39okgMqKg.jpg Scopri quando serve l'approvazione pre-market FDA e come si articolano evidenze PMA, tariffe e tempi di esame. https://stream.mux.com/WEZQpF8YhdddbBNLteXLBkpxiekr4EqDJD39okgMqKg.m3u8 https://player.mux.com/WEZQpF8YhdddbBNLteXLBkpxiekr4EqDJD39okgMqKg?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FWEZQpF8YhdddbBNLteXLBkpxiekr4EqDJD39okgMqKg.jpg&accent-color=%232451c6 105 2026-10-16T04:59:06.512Z 2026-10-15 https://www.pureglobal.com/it/markets/united-states/fda-recognized-consensus-standards-and-doc-guide 2026-10-15 https://www.pureglobal.com/it/markets/united-states/fda-udi-and-gudid-database-submission-guide 2026-10-15 https://www.pureglobal.com/it/markets/united-states/us-fda-510k-clearance-submission-consulting FDA 510(k): clearance e sottomissione https://www.pureglobal.com/assets/video-posters/9eLZMqKyqjKGI02yLiOYiSg9QwaewYbYkd2NVn00ZZJxg.jpg Esplora equivalenza sostanziale, predicati, eSTAR e le tariffe di sottomissione FDA 510(k) trattate nel video. https://stream.mux.com/9eLZMqKyqjKGI02yLiOYiSg9QwaewYbYkd2NVn00ZZJxg.m3u8 https://player.mux.com/9eLZMqKyqjKGI02yLiOYiSg9QwaewYbYkd2NVn00ZZJxg?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F9eLZMqKyqjKGI02yLiOYiSg9QwaewYbYkd2NVn00ZZJxg.jpg&accent-color=%232451c6 111 2026-10-16T04:58:34.086Z 2026-10-15 https://www.pureglobal.com/it/markets/united-states/us-fda-agent-for-medical-devices-companies 2026-10-15 https://www.pureglobal.com/it/markets/united-states/us-fda-medical-device-and-ivd-classification-consulting 2026-10-15 https://www.pureglobal.com/it/markets/united-states/us-fda-medical-device-establishment-registration-and-device-listing 2026-10-15 https://www.pureglobal.com/it/markets/united-states/us-fda-qmsr-consulting-for-medical-devices 2026-10-15 https://www.pureglobal.com/it/markets/vietnam 2026-10-15 https://www.pureglobal.com/it/markets/vietnam/vietnam-medical-device-and-ivd-classification-and-grouping 2026-10-15 https://www.pureglobal.com/it/markets/vietnam/vietnam-medical-device-and-ivd-post-market-requirements 2026-10-15 https://www.pureglobal.com/it/markets/vietnam/vietnam-medical-device-and-ivd-regulations 2026-10-15 https://www.pureglobal.com/it/markets/vietnam/vietnam-medical-device-labeling-requirements 2026-10-15 https://www.pureglobal.com/ja/markets 2026-06-17 https://www.pureglobal.com/ja/markets/argentina 2026-10-15 https://www.pureglobal.com/ja/markets/australia 2026-10-15 https://www.pureglobal.com/ja/markets/australia/artg-sponsor-manufacturer-evidence 2026-10-15 https://www.pureglobal.com/ja/markets/bangladesh 2026-10-15 https://www.pureglobal.com/ja/markets/brazil 2026-10-15 https://www.pureglobal.com/ja/markets/brazil/ai-brazil-anvisa-submissions 2026-10-15 https://www.pureglobal.com/ja/markets/brazil/anvisa-medical-device-classification 2026-10-15 https://www.pureglobal.com/ja/markets/brazil/anvisa-medical-device-labeling 2026-10-15 https://www.pureglobal.com/ja/markets/brazil/anvisa-medical-device-postmarket-surveillance 2026-10-15 https://www.pureglobal.com/ja/markets/brazil/anvisa-medical-device-regulations 2026-10-15 https://www.pureglobal.com/ja/markets/brazil/inmetro-anatel-medical-device-certification 2026-10-15 https://www.pureglobal.com/ja/markets/canada 2026-10-15 https://www.pureglobal.com/ja/markets/canada/medical-device-licence-mdl-vs-mdel 2026-10-15 https://www.pureglobal.com/ja/markets/china 中国NMPA：医療機器登録ルート https://www.pureglobal.com/assets/video-posters/Py5Uz9dIR02qXfIy7796D02yWaXwfVtG023CqZO2CL02gE00.jpg NMPAの機器分類、登録ルート、審査期間、および中国の医療機器GMP体制を解説する動画ガイドです。 https://stream.mux.com/Py5Uz9dIR02qXfIy7796D02yWaXwfVtG023CqZO2CL02gE00.m3u8 https://player.mux.com/Py5Uz9dIR02qXfIy7796D02yWaXwfVtG023CqZO2CL02gE00?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FPy5Uz9dIR02qXfIy7796D02yWaXwfVtG023CqZO2CL02gE00.jpg&accent-color=%232451c6 115 2026-10-16T04:59:21.203Z 2026-10-15 https://www.pureglobal.com/ja/markets/colombia 2026-10-15 https://www.pureglobal.com/ja/markets/colombia/invima-medical-device-classification 2026-10-15 https://www.pureglobal.com/ja/markets/colombia/invima-medical-device-labeling 2026-10-15 https://www.pureglobal.com/ja/markets/colombia/invima-medical-device-postmarket-compliance 2026-10-15 https://www.pureglobal.com/ja/markets/colombia/invima-medical-device-regulations 2026-10-15 https://www.pureglobal.com/ja/markets/costa-rica 2026-10-15 https://www.pureglobal.com/ja/markets/egypt 2026-10-15 https://www.pureglobal.com/ja/markets/european-union 2026-10-15 https://www.pureglobal.com/ja/markets/european-union/ce-mark-notified-body-search EU MDR：認証機関の選定 https://www.pureglobal.com/assets/video-posters/hm5Pl53mUXV00dpBZdTCSQ02AnNlLWYnTs2PIbnOEbGO00.jpg EU MDRに基づき、NANDOを利用して認証機関の指定状況や自社機器の対象範囲を確認する方法を解説します。 https://stream.mux.com/hm5Pl53mUXV00dpBZdTCSQ02AnNlLWYnTs2PIbnOEbGO00.m3u8 https://player.mux.com/hm5Pl53mUXV00dpBZdTCSQ02AnNlLWYnTs2PIbnOEbGO00?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2Fhm5Pl53mUXV00dpBZdTCSQ02AnNlLWYnTs2PIbnOEbGO00.jpg&accent-color=%232451c6 104 2026-10-16T04:58:47.608Z 2026-10-15 https://www.pureglobal.com/ja/markets/european-union/ec-european-authorized-representative EU指定代理人：第11条 https://www.pureglobal.com/assets/video-posters/8f2diZEFPEGBYwbxgEpcIL81gUNdow1kmcCTRB00WES4.jpg EU指定代理人が必要となる条件と、MDRおよびIVDR第11条で定められた要求事項について解説します。 https://stream.mux.com/8f2diZEFPEGBYwbxgEpcIL81gUNdow1kmcCTRB00WES4.m3u8 https://player.mux.com/8f2diZEFPEGBYwbxgEpcIL81gUNdow1kmcCTRB00WES4?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F8f2diZEFPEGBYwbxgEpcIL81gUNdow1kmcCTRB00WES4.jpg&accent-color=%232451c6 100 2026-10-16T04:59:45.925Z 2026-10-15 https://www.pureglobal.com/ja/markets/european-union/eu-ivdr-consulting 2026-10-15 https://www.pureglobal.com/ja/markets/european-union/eu-ivdr-consulting/ce-marking-approval-for-ivds 2026-10-15 https://www.pureglobal.com/ja/markets/european-union/eu-ivdr-consulting/ivdr-classification IVDR：クラスA〜Dと移行期限 https://www.pureglobal.com/assets/video-posters/xFfNtUAJbK9nQD6IlZ41k13i47i2GVxwTtp2JBBYoVA.jpg 本動画で取り上げるIVDRのクラス分類、附属書VIIIの規則、およびレガシーIVDの移行猶予期限について解説します。 https://stream.mux.com/xFfNtUAJbK9nQD6IlZ41k13i47i2GVxwTtp2JBBYoVA.m3u8 https://player.mux.com/xFfNtUAJbK9nQD6IlZ41k13i47i2GVxwTtp2JBBYoVA?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FxFfNtUAJbK9nQD6IlZ41k13i47i2GVxwTtp2JBBYoVA.jpg&accent-color=%232451c6 117 2026-10-16T04:59:40.284Z 2026-10-15 https://www.pureglobal.com/ja/markets/european-union/eu-ivdr-consulting/ivdr-per-performance-evaluation-report 2026-10-15 https://www.pureglobal.com/ja/markets/european-union/eu-ivdr-consulting/pmpf-postmarket-performance 2026-10-15 https://www.pureglobal.com/ja/markets/european-union/eu-mdr-consulting 2026-10-15 https://www.pureglobal.com/ja/markets/european-union/eu-mdr-consulting/eu-mdr-ce-marking-approval-for-medical-devices 2026-10-15 https://www.pureglobal.com/ja/markets/european-union/eu-mdr-consulting/eu-mdr-classification-for-medical-devices EU MDR：医療機器の分類規則 https://www.pureglobal.com/assets/video-posters/E67JA1rg012v0002bCwrk6gZzbkcuT8EyFB19PUTqDzJMQ.jpg 附属書VIII（Annex VIII）の22の規則に基づくEU MDRのクラス分類と、最も厳格な規則の適用方法を解説します。 https://stream.mux.com/E67JA1rg012v0002bCwrk6gZzbkcuT8EyFB19PUTqDzJMQ.m3u8 https://player.mux.com/E67JA1rg012v0002bCwrk6gZzbkcuT8EyFB19PUTqDzJMQ?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FE67JA1rg012v0002bCwrk6gZzbkcuT8EyFB19PUTqDzJMQ.jpg&accent-color=%232451c6 108 2026-10-16T04:59:27.006Z 2026-10-15 https://www.pureglobal.com/ja/markets/european-union/eu-mdr-consulting/eu-mdr-clinical-evaluation-reports-cer-for-medical-devices EU MDR：臨床評価報告書（CER） https://www.pureglobal.com/assets/video-posters/teVFqOlFbuce01lKbdwr2d013lyRTQYKcsR7apvEpQMTI.jpg EU MDRの臨床評価報告書（CER）の概要、必要とされるエビデンス要件、およびCERを最新状態に維持する方法を解説します。 https://stream.mux.com/teVFqOlFbuce01lKbdwr2d013lyRTQYKcsR7apvEpQMTI.m3u8 https://player.mux.com/teVFqOlFbuce01lKbdwr2d013lyRTQYKcsR7apvEpQMTI?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FteVFqOlFbuce01lKbdwr2d013lyRTQYKcsR7apvEpQMTI.jpg&accent-color=%232451c6 110 2026-10-16T04:59:53.863Z 2026-10-15 https://www.pureglobal.com/ja/markets/european-union/eu-mdr-consulting/eu-pmcf-post-market-clinical-follow-up-for-medical-devices EU MDR PMCF：計画・報告・提出時期 https://www.pureglobal.com/assets/video-posters/MeeXg9C003BX00JkwSbbc1wtufRkp7btq3ZAbd1NDSxlo.jpg EU MDRにおける市販後臨床フォローアップ（PMCF）のガイドとして、PMCF計画書、評価報告書、および実施時期について解説します。 https://stream.mux.com/MeeXg9C003BX00JkwSbbc1wtufRkp7btq3ZAbd1NDSxlo.m3u8 https://player.mux.com/MeeXg9C003BX00JkwSbbc1wtufRkp7btq3ZAbd1NDSxlo?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FMeeXg9C003BX00JkwSbbc1wtufRkp7btq3ZAbd1NDSxlo.jpg&accent-color=%232451c6 108 2026-10-16T04:58:54.123Z 2026-10-15 https://www.pureglobal.com/ja/markets/european-union/eu-mdr-gspr-checklist-annex-i 2026-10-15 https://www.pureglobal.com/ja/markets/european-union/eu-mdr-ivdr-person-responsible-for-regulatory-compliance-prrc EU PRRC：第15条の要求事項 https://www.pureglobal.com/assets/video-posters/NcCR00V8nB5wmFTN7C1kJTBAa7Kmlmfi02ee7XwsMyuQM.jpg EU MDRおよびIVDR第15条に基づくPRRC（規制遵守責任者）の役割、資格要件、ならびに職務内容について解説します。 https://stream.mux.com/NcCR00V8nB5wmFTN7C1kJTBAa7Kmlmfi02ee7XwsMyuQM.m3u8 https://player.mux.com/NcCR00V8nB5wmFTN7C1kJTBAa7Kmlmfi02ee7XwsMyuQM?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FNcCR00V8nB5wmFTN7C1kJTBAa7Kmlmfi02ee7XwsMyuQM.jpg&accent-color=%232451c6 108 2026-10-16T04:59:34.224Z 2026-10-15 https://www.pureglobal.com/ja/markets/european-union/eu-mdr-psur-periodic-safety-update-report 2026-10-15 https://www.pureglobal.com/ja/markets/european-union/eudamed-medical-device-ivd-registration 2026-10-15 https://www.pureglobal.com/ja/markets/european-union/mdr-and-ivdr-postmarket-surveillance 2026-10-15 https://www.pureglobal.com/ja/markets/hong-kong 香港MDACS：任意リスティング制度 https://www.pureglobal.com/assets/video-posters/01g3xtsRTru7Ig7A01vNe023Nr38jopQLEqTx6KLhqJ8RQ.jpg 香港のMDACSリスティング制度、CMPR、および本動画で取り上げる制度変更について解説します。 https://stream.mux.com/01g3xtsRTru7Ig7A01vNe023Nr38jopQLEqTx6KLhqJ8RQ.m3u8 https://player.mux.com/01g3xtsRTru7Ig7A01vNe023Nr38jopQLEqTx6KLhqJ8RQ?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F01g3xtsRTru7Ig7A01vNe023Nr38jopQLEqTx6KLhqJ8RQ.jpg&accent-color=%232451c6 101 2026-10-16T04:59:15.866Z 2026-10-15 https://www.pureglobal.com/ja/markets/india 2026-10-15 https://www.pureglobal.com/ja/markets/indonesia 2026-10-15 https://www.pureglobal.com/ja/markets/indonesia/medical-device-classification 2026-10-15 https://www.pureglobal.com/ja/markets/indonesia/medical-device-labeling 2026-10-15 https://www.pureglobal.com/ja/markets/indonesia/medical-device-postmarket-requirements 2026-10-15 https://www.pureglobal.com/ja/markets/indonesia/medical-device-regulations 2026-10-15 https://www.pureglobal.com/ja/markets/israel 2026-10-15 https://www.pureglobal.com/ja/markets/japan 2026-10-15 https://www.pureglobal.com/ja/markets/japan/marketing-authorization-holder-mah-dmah 2026-10-15 https://www.pureglobal.com/ja/markets/macau 2026-10-15 https://www.pureglobal.com/ja/markets/malaysia 2026-10-15 https://www.pureglobal.com/ja/markets/malaysia/mda-medical-device-classification 2026-10-15 https://www.pureglobal.com/ja/markets/malaysia/mda-medical-device-labeling 2026-10-15 https://www.pureglobal.com/ja/markets/malaysia/mda-medical-device-postmarket-requirements 2026-10-15 https://www.pureglobal.com/ja/markets/malaysia/mda-medical-device-regulations 2026-10-15 https://www.pureglobal.com/ja/markets/mexico 2026-10-15 https://www.pureglobal.com/ja/markets/mexico/cofepris-medical-device-and-ivd-classification 2026-10-15 https://www.pureglobal.com/ja/markets/mexico/cofepris-medical-device-labeling 2026-10-15 https://www.pureglobal.com/ja/markets/mexico/cofepris-medical-device-postmarket-compliance 2026-10-15 https://www.pureglobal.com/ja/markets/mexico/cofepris-medical-device-regulations 2026-10-15 https://www.pureglobal.com/ja/markets/new-zealand 2026-10-15 https://www.pureglobal.com/ja/markets/pakistan 2026-10-15 https://www.pureglobal.com/ja/markets/peru ペルーDIGEMID：登録期間と手数料 https://www.pureglobal.com/assets/video-posters/PgJluzdF01VY00Yazash8pKwFUhg8w02jyHeCw02sjh1VPM.jpg ペルーの医療機器登録ルート、ならびに本動画で取り上げるDIGEMIDの審査期間と手数料について解説します。 https://stream.mux.com/PgJluzdF01VY00Yazash8pKwFUhg8w02jyHeCw02sjh1VPM.m3u8 https://player.mux.com/PgJluzdF01VY00Yazash8pKwFUhg8w02jyHeCw02sjh1VPM?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FPgJluzdF01VY00Yazash8pKwFUhg8w02jyHeCw02sjh1VPM.jpg&accent-color=%232451c6 109 2026-10-16T05:00:08.644Z 2026-10-15 https://www.pureglobal.com/ja/markets/philippines フィリピンFDA：CMDNかCMDRか https://www.pureglobal.com/assets/video-posters/Hfkt6CXufVLkbOFBferCDgsxd0101j3BPO5R5ZQhxIdhU.jpg フィリピンFDAのCMDNおよびCMDR申請ルートと、本動画で取り上げる登録制度の変更点を解説します。 https://stream.mux.com/Hfkt6CXufVLkbOFBferCDgsxd0101j3BPO5R5ZQhxIdhU.m3u8 https://player.mux.com/Hfkt6CXufVLkbOFBferCDgsxd0101j3BPO5R5ZQhxIdhU?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FHfkt6CXufVLkbOFBferCDgsxd0101j3BPO5R5ZQhxIdhU.jpg&accent-color=%232451c6 114 2026-10-16T04:59:00.292Z 2026-10-15 https://www.pureglobal.com/ja/markets/saudi-arabia 2026-10-15 https://www.pureglobal.com/ja/markets/singapore 2026-10-15 https://www.pureglobal.com/ja/markets/singapore/hsa-medical-device-classification 2026-10-15 https://www.pureglobal.com/ja/markets/singapore/hsa-medical-device-labeling 2026-10-15 https://www.pureglobal.com/ja/markets/singapore/hsa-medical-device-postmarket-surveillance 2026-10-15 https://www.pureglobal.com/ja/markets/singapore/hsa-medical-device-regulations 2026-10-15 https://www.pureglobal.com/ja/markets/south-korea 韓国MFDS：医療機器登録 https://www.pureglobal.com/assets/video-posters/tRBfiLaVikYUQunZna7jnZgQOb81jfyeEhsQO78haX8.jpg 韓国の医療機器クラス分類、MFDSの登録ルート、審査期間、および5年ごとの更新手続きについて解説します。 https://stream.mux.com/tRBfiLaVikYUQunZna7jnZgQOb81jfyeEhsQO78haX8.m3u8 https://player.mux.com/tRBfiLaVikYUQunZna7jnZgQOb81jfyeEhsQO78haX8?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FtRBfiLaVikYUQunZna7jnZgQOb81jfyeEhsQO78haX8.jpg&accent-color=%232451c6 104 2026-10-16T04:59:57.021Z 2026-10-15 https://www.pureglobal.com/ja/markets/switzerland 2026-10-15 https://www.pureglobal.com/ja/markets/taiwan 2026-10-15 https://www.pureglobal.com/ja/markets/thailand 2026-10-15 https://www.pureglobal.com/ja/markets/thailand/thailand-medical-device-and-ivd-classification 2026-10-15 https://www.pureglobal.com/ja/markets/thailand/thailand-medical-device-and-ivd-labeling-requirements 2026-10-15 https://www.pureglobal.com/ja/markets/thailand/thailand-medical-device-and-ivd-regulations 2026-10-15 https://www.pureglobal.com/ja/markets/thailand/thailand-medical-device-post-market-requirements 2026-10-15 https://www.pureglobal.com/ja/markets/uae 2026-10-15 https://www.pureglobal.com/ja/markets/united-kingdom 2026-10-15 https://www.pureglobal.com/ja/markets/united-kingdom/uk-responsible-person-medical-devices 2026-10-15 https://www.pureglobal.com/ja/markets/united-states 2026-10-15 https://www.pureglobal.com/ja/markets/united-states/fda-21-cfr-part-801-medical-device-labeling-and-iso-15223-symbols 2026-10-15 https://www.pureglobal.com/ja/markets/united-states/fda-483-and-warning-letter-response-and-consulting FDA Form 483：回答と警告書 https://www.pureglobal.com/assets/video-posters/binE4h84L7wmSv6V9M9p75OaUNQkD8H6oRA2pfQ4YYM.jpg Form 483の指摘事項、回答期限、警告書、およびFDAの査察結果について解説します。 https://stream.mux.com/binE4h84L7wmSv6V9M9p75OaUNQkD8H6oRA2pfQ4YYM.m3u8 https://player.mux.com/binE4h84L7wmSv6V9M9p75OaUNQkD8H6oRA2pfQ4YYM?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FbinE4h84L7wmSv6V9M9p75OaUNQkD8H6oRA2pfQ4YYM.jpg&accent-color=%232451c6 108 2026-10-16T04:57:51.770Z 2026-10-15 https://www.pureglobal.com/ja/markets/united-states/fda-biocompatibility-iso-10993-evaluation-guide 2026-10-15 https://www.pureglobal.com/ja/markets/united-states/fda-certificate-to-foreign-government-cfg-for-medical-devices FDA CFG：医療機器輸出証明書 https://www.pureglobal.com/assets/video-posters/fS276ccoWXokDxwtDforbRhDHmMWdtaxx67gerBBBeE.jpg FDAの外国政府向け証明書（CFG）の対象範囲、輸出者に必要となる状況、および申請手順について解説します。 https://stream.mux.com/fS276ccoWXokDxwtDforbRhDHmMWdtaxx67gerBBBeE.m3u8 https://player.mux.com/fS276ccoWXokDxwtDforbRhDHmMWdtaxx67gerBBBeE?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FfS276ccoWXokDxwtDforbRhDHmMWdtaxx67gerBBBeE.jpg&accent-color=%232451c6 107 2026-10-16T04:58:42.168Z 2026-10-15 https://www.pureglobal.com/ja/markets/united-states/fda-de-novo-classification-request 2026-10-15 https://www.pureglobal.com/ja/markets/united-states/fda-estar-submission-template-guide 2026-10-15 https://www.pureglobal.com/ja/markets/united-states/fda-ide-and-breakthrough-device-designation-guide 2026-10-15 https://www.pureglobal.com/ja/markets/united-states/fda-medical-device-reporting-mdr-consulting FDA MDR：医療機器報告制度 https://www.pureglobal.com/assets/video-posters/AkU7r439f004ndRky18ENwIzhgrzkb28GCKrfrReVjYM.jpg 21 CFR 803の概要、医療機器報告の提出期限、5日報告、および電子MDR（eMDR）申請について解説します。 https://stream.mux.com/AkU7r439f004ndRky18ENwIzhgrzkb28GCKrfrReVjYM.m3u8 https://player.mux.com/AkU7r439f004ndRky18ENwIzhgrzkb28GCKrfrReVjYM?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FAkU7r439f004ndRky18ENwIzhgrzkb28GCKrfrReVjYM.jpg&accent-color=%232451c6 109 2026-10-16T04:58:11.613Z 2026-10-15 https://www.pureglobal.com/ja/markets/united-states/fda-pre-sub-guidance-and-q-sub-guidance-for-medical-devices FDA Pre-Sub：Q-Sub申請 https://www.pureglobal.com/assets/video-posters/be1w25SmygP8Eg02Vh3JuxdRmF8LXQyxZRgtgWwy01YUI.jpg FDAのPre-Sub面談、Q-Submissionの種類、タイムライン、および的を絞った質問事項の準備方法について解説します。 https://stream.mux.com/be1w25SmygP8Eg02Vh3JuxdRmF8LXQyxZRgtgWwy01YUI.m3u8 https://player.mux.com/be1w25SmygP8Eg02Vh3JuxdRmF8LXQyxZRgtgWwy01YUI?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2Fbe1w25SmygP8Eg02Vh3JuxdRmF8LXQyxZRgtgWwy01YUI.jpg&accent-color=%232451c6 105 2026-10-16T04:58:29.478Z 2026-10-15 https://www.pureglobal.com/ja/markets/united-states/fda-premarket-approval-pma-submission-consulting-for-medical-devices FDA PMA：市販前承認の解説 https://www.pureglobal.com/assets/video-posters/WEZQpF8YhdddbBNLteXLBkpxiekr4EqDJD39okgMqKg.jpg 医療機器にFDAの市販前承認（PMA）が必要となる条件と、提出データ、手数料、審査期間の関連性を解説します。 https://stream.mux.com/WEZQpF8YhdddbBNLteXLBkpxiekr4EqDJD39okgMqKg.m3u8 https://player.mux.com/WEZQpF8YhdddbBNLteXLBkpxiekr4EqDJD39okgMqKg?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FWEZQpF8YhdddbBNLteXLBkpxiekr4EqDJD39okgMqKg.jpg&accent-color=%232451c6 105 2026-10-16T04:59:06.512Z 2026-10-15 https://www.pureglobal.com/ja/markets/united-states/fda-recognized-consensus-standards-and-doc-guide 2026-10-15 https://www.pureglobal.com/ja/markets/united-states/fda-udi-and-gudid-database-submission-guide 2026-10-15 https://www.pureglobal.com/ja/markets/united-states/us-fda-510k-clearance-submission-consulting FDA 510(k)：認可と申請 https://www.pureglobal.com/assets/video-posters/9eLZMqKyqjKGI02yLiOYiSg9QwaewYbYkd2NVn00ZZJxg.jpg 本動画で取り上げる実質的同等性、対照機器（プレディケート）、eSTAR、およびFDA 510(k)の申請手数料について解説します。 https://stream.mux.com/9eLZMqKyqjKGI02yLiOYiSg9QwaewYbYkd2NVn00ZZJxg.m3u8 https://player.mux.com/9eLZMqKyqjKGI02yLiOYiSg9QwaewYbYkd2NVn00ZZJxg?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F9eLZMqKyqjKGI02yLiOYiSg9QwaewYbYkd2NVn00ZZJxg.jpg&accent-color=%232451c6 111 2026-10-16T04:58:34.086Z 2026-10-15 https://www.pureglobal.com/ja/markets/united-states/us-fda-agent-for-medical-devices-companies 2026-10-15 https://www.pureglobal.com/ja/markets/united-states/us-fda-medical-device-and-ivd-classification-consulting 2026-10-15 https://www.pureglobal.com/ja/markets/united-states/us-fda-medical-device-establishment-registration-and-device-listing 2026-10-15 https://www.pureglobal.com/ja/markets/united-states/us-fda-qmsr-consulting-for-medical-devices 2026-10-15 https://www.pureglobal.com/ja/markets/vietnam 2026-10-15 https://www.pureglobal.com/ja/markets/vietnam/vietnam-medical-device-and-ivd-classification-and-grouping 2026-10-15 https://www.pureglobal.com/ja/markets/vietnam/vietnam-medical-device-and-ivd-post-market-requirements 2026-10-15 https://www.pureglobal.com/ja/markets/vietnam/vietnam-medical-device-and-ivd-regulations 2026-10-15 https://www.pureglobal.com/ja/markets/vietnam/vietnam-medical-device-labeling-requirements 2026-10-15 https://www.pureglobal.com/ko/markets 2026-06-30 https://www.pureglobal.com/ko/markets/argentina 2026-10-15 https://www.pureglobal.com/ko/markets/australia 2026-10-15 https://www.pureglobal.com/ko/markets/australia/artg-sponsor-manufacturer-evidence 2026-10-15 https://www.pureglobal.com/ko/markets/bangladesh 2026-10-15 https://www.pureglobal.com/ko/markets/brazil 2026-10-15 https://www.pureglobal.com/ko/markets/brazil/ai-brazil-anvisa-submissions 2026-10-15 https://www.pureglobal.com/ko/markets/brazil/anvisa-medical-device-classification 2026-10-15 https://www.pureglobal.com/ko/markets/brazil/anvisa-medical-device-labeling 2026-10-15 https://www.pureglobal.com/ko/markets/brazil/anvisa-medical-device-postmarket-surveillance 2026-10-15 https://www.pureglobal.com/ko/markets/brazil/anvisa-medical-device-regulations 2026-10-15 https://www.pureglobal.com/ko/markets/brazil/inmetro-anatel-medical-device-certification 2026-10-15 https://www.pureglobal.com/ko/markets/canada 2026-10-15 https://www.pureglobal.com/ko/markets/canada/medical-device-licence-mdl-vs-mdel 2026-10-15 https://www.pureglobal.com/ko/markets/china 중국 NMPA: 의료기기 등록 경로 https://www.pureglobal.com/assets/video-posters/Py5Uz9dIR02qXfIy7796D02yWaXwfVtG023CqZO2CL02gE00.jpg NMPA 의료기기 등급, 등록 경로, 심사 기간 및 중국의 의료기기 GMP 프레임워크를 안내하는 동영상 가이드입니다. https://stream.mux.com/Py5Uz9dIR02qXfIy7796D02yWaXwfVtG023CqZO2CL02gE00.m3u8 https://player.mux.com/Py5Uz9dIR02qXfIy7796D02yWaXwfVtG023CqZO2CL02gE00?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FPy5Uz9dIR02qXfIy7796D02yWaXwfVtG023CqZO2CL02gE00.jpg&accent-color=%232451c6 115 2026-10-16T04:59:21.203Z 2026-10-15 https://www.pureglobal.com/ko/markets/colombia 2026-10-15 https://www.pureglobal.com/ko/markets/colombia/invima-medical-device-classification 2026-10-15 https://www.pureglobal.com/ko/markets/colombia/invima-medical-device-labeling 2026-10-15 https://www.pureglobal.com/ko/markets/colombia/invima-medical-device-postmarket-compliance 2026-10-15 https://www.pureglobal.com/ko/markets/colombia/invima-medical-device-regulations 2026-10-15 https://www.pureglobal.com/ko/markets/costa-rica 2026-10-15 https://www.pureglobal.com/ko/markets/egypt 2026-10-15 https://www.pureglobal.com/ko/markets/european-union 2026-10-15 https://www.pureglobal.com/ko/markets/european-union/ce-mark-notified-body-search EU MDR: 인증기관 선정 https://www.pureglobal.com/assets/video-posters/hm5Pl53mUXV00dpBZdTCSQ02AnNlLWYnTs2PIbnOEbGO00.jpg EU MDR에 따라 NANDO를 활용하여 인증기관(Notified Body)의 지정 여부와 보유 기기에 대한 심사 범위를 확인하는 방법을 알아봅니다. https://stream.mux.com/hm5Pl53mUXV00dpBZdTCSQ02AnNlLWYnTs2PIbnOEbGO00.m3u8 https://player.mux.com/hm5Pl53mUXV00dpBZdTCSQ02AnNlLWYnTs2PIbnOEbGO00?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2Fhm5Pl53mUXV00dpBZdTCSQ02AnNlLWYnTs2PIbnOEbGO00.jpg&accent-color=%232451c6 104 2026-10-16T04:58:47.608Z 2026-10-15 https://www.pureglobal.com/ko/markets/european-union/ec-european-authorized-representative EU 공인대리인: 제11조 https://www.pureglobal.com/assets/video-posters/8f2diZEFPEGBYwbxgEpcIL81gUNdow1kmcCTRB00WES4.jpg EU 공인대리인이 필요한 시점과 MDR 및 IVDR 제11조의 요구사항을 알아봅니다. https://stream.mux.com/8f2diZEFPEGBYwbxgEpcIL81gUNdow1kmcCTRB00WES4.m3u8 https://player.mux.com/8f2diZEFPEGBYwbxgEpcIL81gUNdow1kmcCTRB00WES4?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F8f2diZEFPEGBYwbxgEpcIL81gUNdow1kmcCTRB00WES4.jpg&accent-color=%232451c6 100 2026-10-16T04:59:45.925Z 2026-10-15 https://www.pureglobal.com/ko/markets/european-union/eu-ivdr-consulting 2026-10-15 https://www.pureglobal.com/ko/markets/european-union/eu-ivdr-consulting/ce-marking-approval-for-ivds 2026-10-15 https://www.pureglobal.com/ko/markets/european-union/eu-ivdr-consulting/ivdr-classification IVDR: A–D 등급 및 전환 유예 기한 https://www.pureglobal.com/assets/video-posters/xFfNtUAJbK9nQD6IlZ41k13i47i2GVxwTtp2JBBYoVA.jpg 본 영상에서 다루는 IVDR 분류 체계, Annex VIII 규칙 및 기존(레거시) IVD의 전환 유예 기한을 살펴봅니다. https://stream.mux.com/xFfNtUAJbK9nQD6IlZ41k13i47i2GVxwTtp2JBBYoVA.m3u8 https://player.mux.com/xFfNtUAJbK9nQD6IlZ41k13i47i2GVxwTtp2JBBYoVA?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FxFfNtUAJbK9nQD6IlZ41k13i47i2GVxwTtp2JBBYoVA.jpg&accent-color=%232451c6 117 2026-10-16T04:59:40.284Z 2026-10-15 https://www.pureglobal.com/ko/markets/european-union/eu-ivdr-consulting/ivdr-per-performance-evaluation-report 2026-10-15 https://www.pureglobal.com/ko/markets/european-union/eu-ivdr-consulting/pmpf-postmarket-performance 2026-10-15 https://www.pureglobal.com/ko/markets/european-union/eu-mdr-consulting 2026-10-15 https://www.pureglobal.com/ko/markets/european-union/eu-mdr-consulting/eu-mdr-ce-marking-approval-for-medical-devices 2026-10-15 https://www.pureglobal.com/ko/markets/european-union/eu-mdr-consulting/eu-mdr-classification-for-medical-devices EU MDR: 의료기기 품목 분류 규칙 https://www.pureglobal.com/assets/video-posters/E67JA1rg012v0002bCwrk6gZzbkcuT8EyFB19PUTqDzJMQ.jpg 22개의 Annex VIII 규칙이 EU MDR 의료기기 등급을 결정하는 방식과 가장 엄격한 관련 규칙을 적용하는 방법을 알아봅니다. https://stream.mux.com/E67JA1rg012v0002bCwrk6gZzbkcuT8EyFB19PUTqDzJMQ.m3u8 https://player.mux.com/E67JA1rg012v0002bCwrk6gZzbkcuT8EyFB19PUTqDzJMQ?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FE67JA1rg012v0002bCwrk6gZzbkcuT8EyFB19PUTqDzJMQ.jpg&accent-color=%232451c6 108 2026-10-16T04:59:27.006Z 2026-10-15 https://www.pureglobal.com/ko/markets/european-union/eu-mdr-consulting/eu-mdr-clinical-evaluation-reports-cer-for-medical-devices EU MDR: 임상평가보고서(CER) https://www.pureglobal.com/assets/video-posters/teVFqOlFbuce01lKbdwr2d013lyRTQYKcsR7apvEpQMTI.jpg EU MDR 임상평가보고서(CER), 임상적 근거 요건 및 CER 최신 상태 유지 방법에 대해 소개합니다. https://stream.mux.com/teVFqOlFbuce01lKbdwr2d013lyRTQYKcsR7apvEpQMTI.m3u8 https://player.mux.com/teVFqOlFbuce01lKbdwr2d013lyRTQYKcsR7apvEpQMTI?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FteVFqOlFbuce01lKbdwr2d013lyRTQYKcsR7apvEpQMTI.jpg&accent-color=%232451c6 110 2026-10-16T04:59:53.863Z 2026-10-15 https://www.pureglobal.com/ko/markets/european-union/eu-mdr-consulting/eu-pmcf-post-market-clinical-follow-up-for-medical-devices EU MDR PMCF: 계획서, 보고서 및 일정 https://www.pureglobal.com/assets/video-posters/MeeXg9C003BX00JkwSbbc1wtufRkp7btq3ZAbd1NDSxlo.jpg PMCF 계획서, 평가 보고서 및 진행 일정을 포함한 EU MDR 기반 시판 후 임상 추적관찰(PMCF) 가이드입니다. https://stream.mux.com/MeeXg9C003BX00JkwSbbc1wtufRkp7btq3ZAbd1NDSxlo.m3u8 https://player.mux.com/MeeXg9C003BX00JkwSbbc1wtufRkp7btq3ZAbd1NDSxlo?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FMeeXg9C003BX00JkwSbbc1wtufRkp7btq3ZAbd1NDSxlo.jpg&accent-color=%232451c6 108 2026-10-16T04:58:54.123Z 2026-10-15 https://www.pureglobal.com/ko/markets/european-union/eu-mdr-gspr-checklist-annex-i 2026-10-15 https://www.pureglobal.com/ko/markets/european-union/eu-mdr-ivdr-person-responsible-for-regulatory-compliance-prrc EU PRRC: 제15조 요건 https://www.pureglobal.com/assets/video-posters/NcCR00V8nB5wmFTN7C1kJTBAa7Kmlmfi02ee7XwsMyuQM.jpg 자격 요건과 책임을 포함하여 EU MDR 및 IVDR 제15조에 따른 규제준수책임자(PRRC)의 역할을 알아봅니다. https://stream.mux.com/NcCR00V8nB5wmFTN7C1kJTBAa7Kmlmfi02ee7XwsMyuQM.m3u8 https://player.mux.com/NcCR00V8nB5wmFTN7C1kJTBAa7Kmlmfi02ee7XwsMyuQM?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FNcCR00V8nB5wmFTN7C1kJTBAa7Kmlmfi02ee7XwsMyuQM.jpg&accent-color=%232451c6 108 2026-10-16T04:59:34.224Z 2026-10-15 https://www.pureglobal.com/ko/markets/european-union/eu-mdr-psur-periodic-safety-update-report 2026-10-15 https://www.pureglobal.com/ko/markets/european-union/eudamed-medical-device-ivd-registration 2026-10-15 https://www.pureglobal.com/ko/markets/european-union/mdr-and-ivdr-postmarket-surveillance 2026-10-15 https://www.pureglobal.com/ko/markets/hong-kong 홍콩 MDACS: 자발적 등재 제도 https://www.pureglobal.com/assets/video-posters/01g3xtsRTru7Ig7A01vNe023Nr38jopQLEqTx6KLhqJ8RQ.jpg 홍콩의 MDACS 등재 프레임워크, CMPR 및 본 영상에서 다루는 주요 변경 사항을 살펴봅니다. https://stream.mux.com/01g3xtsRTru7Ig7A01vNe023Nr38jopQLEqTx6KLhqJ8RQ.m3u8 https://player.mux.com/01g3xtsRTru7Ig7A01vNe023Nr38jopQLEqTx6KLhqJ8RQ?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F01g3xtsRTru7Ig7A01vNe023Nr38jopQLEqTx6KLhqJ8RQ.jpg&accent-color=%232451c6 101 2026-10-16T04:59:15.866Z 2026-10-15 https://www.pureglobal.com/ko/markets/india 2026-10-15 https://www.pureglobal.com/ko/markets/indonesia 2026-10-15 https://www.pureglobal.com/ko/markets/indonesia/medical-device-classification 2026-10-15 https://www.pureglobal.com/ko/markets/indonesia/medical-device-labeling 2026-10-15 https://www.pureglobal.com/ko/markets/indonesia/medical-device-postmarket-requirements 2026-10-15 https://www.pureglobal.com/ko/markets/indonesia/medical-device-regulations 2026-10-15 https://www.pureglobal.com/ko/markets/israel 2026-10-15 https://www.pureglobal.com/ko/markets/japan 2026-10-15 https://www.pureglobal.com/ko/markets/japan/marketing-authorization-holder-mah-dmah 2026-10-15 https://www.pureglobal.com/ko/markets/macau 2026-10-15 https://www.pureglobal.com/ko/markets/malaysia 2026-10-15 https://www.pureglobal.com/ko/markets/malaysia/mda-medical-device-classification 2026-10-15 https://www.pureglobal.com/ko/markets/malaysia/mda-medical-device-labeling 2026-10-15 https://www.pureglobal.com/ko/markets/malaysia/mda-medical-device-postmarket-requirements 2026-10-15 https://www.pureglobal.com/ko/markets/malaysia/mda-medical-device-regulations 2026-10-15 https://www.pureglobal.com/ko/markets/mexico 2026-10-15 https://www.pureglobal.com/ko/markets/mexico/cofepris-medical-device-and-ivd-classification 2026-10-15 https://www.pureglobal.com/ko/markets/mexico/cofepris-medical-device-labeling 2026-10-15 https://www.pureglobal.com/ko/markets/mexico/cofepris-medical-device-postmarket-compliance 2026-10-15 https://www.pureglobal.com/ko/markets/mexico/cofepris-medical-device-regulations 2026-10-15 https://www.pureglobal.com/ko/markets/new-zealand 2026-10-15 https://www.pureglobal.com/ko/markets/pakistan 2026-10-15 https://www.pureglobal.com/ko/markets/peru 페루 DIGEMID: 등록 기간 및 수수료 https://www.pureglobal.com/assets/video-posters/PgJluzdF01VY00Yazash8pKwFUhg8w02jyHeCw02sjh1VPM.jpg 본 영상에서 다루는 페루의 의료기기 등록 경로와 DIGEMID 심사 기간 및 수수료에 대해 알아봅니다. https://stream.mux.com/PgJluzdF01VY00Yazash8pKwFUhg8w02jyHeCw02sjh1VPM.m3u8 https://player.mux.com/PgJluzdF01VY00Yazash8pKwFUhg8w02jyHeCw02sjh1VPM?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FPgJluzdF01VY00Yazash8pKwFUhg8w02jyHeCw02sjh1VPM.jpg&accent-color=%232451c6 109 2026-10-16T05:00:08.644Z 2026-10-15 https://www.pureglobal.com/ko/markets/philippines 필리핀 FDA: CMDN 또는 CMDR? https://www.pureglobal.com/assets/video-posters/Hfkt6CXufVLkbOFBferCDgsxd0101j3BPO5R5ZQhxIdhU.jpg 필리핀 FDA의 CMDN 및 CMDR 경로와 본 영상에서 다루는 등록 변경 사항을 알아봅니다. https://stream.mux.com/Hfkt6CXufVLkbOFBferCDgsxd0101j3BPO5R5ZQhxIdhU.m3u8 https://player.mux.com/Hfkt6CXufVLkbOFBferCDgsxd0101j3BPO5R5ZQhxIdhU?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FHfkt6CXufVLkbOFBferCDgsxd0101j3BPO5R5ZQhxIdhU.jpg&accent-color=%232451c6 114 2026-10-16T04:59:00.292Z 2026-10-15 https://www.pureglobal.com/ko/markets/saudi-arabia 2026-10-15 https://www.pureglobal.com/ko/markets/singapore 2026-10-15 https://www.pureglobal.com/ko/markets/singapore/hsa-medical-device-classification 2026-10-15 https://www.pureglobal.com/ko/markets/singapore/hsa-medical-device-labeling 2026-10-15 https://www.pureglobal.com/ko/markets/singapore/hsa-medical-device-postmarket-surveillance 2026-10-15 https://www.pureglobal.com/ko/markets/singapore/hsa-medical-device-regulations 2026-10-15 https://www.pureglobal.com/ko/markets/south-korea 한국 MFDS: 의료기기 등록 https://www.pureglobal.com/assets/video-posters/tRBfiLaVikYUQunZna7jnZgQOb81jfyeEhsQO78haX8.jpg 한국의 의료기기 등급, MFDS 등록 경로, 심사 기간 및 5년 주기 갱신 제도를 살펴봅니다. https://stream.mux.com/tRBfiLaVikYUQunZna7jnZgQOb81jfyeEhsQO78haX8.m3u8 https://player.mux.com/tRBfiLaVikYUQunZna7jnZgQOb81jfyeEhsQO78haX8?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FtRBfiLaVikYUQunZna7jnZgQOb81jfyeEhsQO78haX8.jpg&accent-color=%232451c6 104 2026-10-16T04:59:57.021Z 2026-10-15 https://www.pureglobal.com/ko/markets/switzerland 2026-10-15 https://www.pureglobal.com/ko/markets/taiwan 2026-10-15 https://www.pureglobal.com/ko/markets/thailand 2026-10-15 https://www.pureglobal.com/ko/markets/thailand/thailand-medical-device-and-ivd-classification 2026-10-15 https://www.pureglobal.com/ko/markets/thailand/thailand-medical-device-and-ivd-labeling-requirements 2026-10-15 https://www.pureglobal.com/ko/markets/thailand/thailand-medical-device-and-ivd-regulations 2026-10-15 https://www.pureglobal.com/ko/markets/thailand/thailand-medical-device-post-market-requirements 2026-10-15 https://www.pureglobal.com/ko/markets/uae 2026-10-15 https://www.pureglobal.com/ko/markets/united-kingdom 2026-10-15 https://www.pureglobal.com/ko/markets/united-kingdom/uk-responsible-person-medical-devices 2026-10-15 https://www.pureglobal.com/ko/markets/united-states 2026-10-15 https://www.pureglobal.com/ko/markets/united-states/fda-21-cfr-part-801-medical-device-labeling-and-iso-15223-symbols 2026-10-15 https://www.pureglobal.com/ko/markets/united-states/fda-483-and-warning-letter-response-and-consulting FDA Form 483: 답변 및 경고 서한 https://www.pureglobal.com/assets/video-posters/binE4h84L7wmSv6V9M9p75OaUNQkD8H6oRA2pfQ4YYM.jpg Form 483 지적 사항, 답변 기한, 경고 서한 및 FDA 실사 결과에 대해 알아봅니다. https://stream.mux.com/binE4h84L7wmSv6V9M9p75OaUNQkD8H6oRA2pfQ4YYM.m3u8 https://player.mux.com/binE4h84L7wmSv6V9M9p75OaUNQkD8H6oRA2pfQ4YYM?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FbinE4h84L7wmSv6V9M9p75OaUNQkD8H6oRA2pfQ4YYM.jpg&accent-color=%232451c6 108 2026-10-16T04:57:51.770Z 2026-10-15 https://www.pureglobal.com/ko/markets/united-states/fda-biocompatibility-iso-10993-evaluation-guide 2026-10-15 https://www.pureglobal.com/ko/markets/united-states/fda-certificate-to-foreign-government-cfg-for-medical-devices FDA CFG: 의료기기 수출 증명서 https://www.pureglobal.com/assets/video-posters/fS276ccoWXokDxwtDforbRhDHmMWdtaxx67gerBBBeE.jpg FDA 외국정부발행 수출증명서(CFG)의 대상 범위, 수출업체에 필요한 시점 및 신청 절차를 알아봅니다. https://stream.mux.com/fS276ccoWXokDxwtDforbRhDHmMWdtaxx67gerBBBeE.m3u8 https://player.mux.com/fS276ccoWXokDxwtDforbRhDHmMWdtaxx67gerBBBeE?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FfS276ccoWXokDxwtDforbRhDHmMWdtaxx67gerBBBeE.jpg&accent-color=%232451c6 107 2026-10-16T04:58:42.168Z 2026-10-15 https://www.pureglobal.com/ko/markets/united-states/fda-de-novo-classification-request 2026-10-15 https://www.pureglobal.com/ko/markets/united-states/fda-estar-submission-template-guide 2026-10-15 https://www.pureglobal.com/ko/markets/united-states/fda-ide-and-breakthrough-device-designation-guide 2026-10-15 https://www.pureglobal.com/ko/markets/united-states/fda-medical-device-reporting-mdr-consulting FDA MDR: 의료기기 보고 제도 https://www.pureglobal.com/assets/video-posters/AkU7r439f004ndRky18ENwIzhgrzkb28GCKrfrReVjYM.jpg 21 CFR 803, 의료기기 보고 기한, 5일 보고 및 전자 MDR 제출에 대한 개요를 제공합니다. https://stream.mux.com/AkU7r439f004ndRky18ENwIzhgrzkb28GCKrfrReVjYM.m3u8 https://player.mux.com/AkU7r439f004ndRky18ENwIzhgrzkb28GCKrfrReVjYM?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FAkU7r439f004ndRky18ENwIzhgrzkb28GCKrfrReVjYM.jpg&accent-color=%232451c6 109 2026-10-16T04:58:11.613Z 2026-10-15 https://www.pureglobal.com/ko/markets/united-states/fda-pre-sub-guidance-and-q-sub-guidance-for-medical-devices FDA Pre-Sub: Q-Sub 절차 https://www.pureglobal.com/assets/video-posters/be1w25SmygP8Eg02Vh3JuxdRmF8LXQyxZRgtgWwy01YUI.jpg FDA Pre-Sub 회의, Q-Submission 유형, 일정 및 핵심 질문을 준비하는 방법을 알아봅니다. https://stream.mux.com/be1w25SmygP8Eg02Vh3JuxdRmF8LXQyxZRgtgWwy01YUI.m3u8 https://player.mux.com/be1w25SmygP8Eg02Vh3JuxdRmF8LXQyxZRgtgWwy01YUI?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2Fbe1w25SmygP8Eg02Vh3JuxdRmF8LXQyxZRgtgWwy01YUI.jpg&accent-color=%232451c6 105 2026-10-16T04:58:29.478Z 2026-10-15 https://www.pureglobal.com/ko/markets/united-states/fda-premarket-approval-pma-submission-consulting-for-medical-devices FDA PMA: 시판 전 승인 해설 https://www.pureglobal.com/assets/video-posters/WEZQpF8YhdddbBNLteXLBkpxiekr4EqDJD39okgMqKg.jpg 의료기기에 FDA 시판 전 승인(PMA)이 필요한 시점과 PMA 근거 자료, 수수료 및 심사 기간이 어떻게 연계되는지 알아봅니다. https://stream.mux.com/WEZQpF8YhdddbBNLteXLBkpxiekr4EqDJD39okgMqKg.m3u8 https://player.mux.com/WEZQpF8YhdddbBNLteXLBkpxiekr4EqDJD39okgMqKg?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FWEZQpF8YhdddbBNLteXLBkpxiekr4EqDJD39okgMqKg.jpg&accent-color=%232451c6 105 2026-10-16T04:59:06.512Z 2026-10-15 https://www.pureglobal.com/ko/markets/united-states/fda-recognized-consensus-standards-and-doc-guide 2026-10-15 https://www.pureglobal.com/ko/markets/united-states/fda-udi-and-gudid-database-submission-guide 2026-10-15 https://www.pureglobal.com/ko/markets/united-states/us-fda-510k-clearance-submission-consulting FDA 510(k): 허가 및 제출 https://www.pureglobal.com/assets/video-posters/9eLZMqKyqjKGI02yLiOYiSg9QwaewYbYkd2NVn00ZZJxg.jpg 본 영상에서 다루는 실질적 동등성, 비교 제품(predicate), eSTAR 및 FDA 510(k) 제출 수수료를 살펴봅니다. https://stream.mux.com/9eLZMqKyqjKGI02yLiOYiSg9QwaewYbYkd2NVn00ZZJxg.m3u8 https://player.mux.com/9eLZMqKyqjKGI02yLiOYiSg9QwaewYbYkd2NVn00ZZJxg?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F9eLZMqKyqjKGI02yLiOYiSg9QwaewYbYkd2NVn00ZZJxg.jpg&accent-color=%232451c6 111 2026-10-16T04:58:34.086Z 2026-10-15 https://www.pureglobal.com/ko/markets/united-states/us-fda-agent-for-medical-devices-companies 2026-10-15 https://www.pureglobal.com/ko/markets/united-states/us-fda-medical-device-and-ivd-classification-consulting 2026-10-15 https://www.pureglobal.com/ko/markets/united-states/us-fda-medical-device-establishment-registration-and-device-listing 2026-10-15 https://www.pureglobal.com/ko/markets/united-states/us-fda-qmsr-consulting-for-medical-devices 2026-10-15 https://www.pureglobal.com/ko/markets/vietnam 2026-10-15 https://www.pureglobal.com/ko/markets/vietnam/vietnam-medical-device-and-ivd-classification-and-grouping 2026-10-15 https://www.pureglobal.com/ko/markets/vietnam/vietnam-medical-device-and-ivd-post-market-requirements 2026-10-15 https://www.pureglobal.com/ko/markets/vietnam/vietnam-medical-device-and-ivd-regulations 2026-10-15 https://www.pureglobal.com/ko/markets/vietnam/vietnam-medical-device-labeling-requirements 2026-10-15 https://www.pureglobal.com/markets 2026-06-17 https://www.pureglobal.com/markets/argentina 2026-10-15 https://www.pureglobal.com/markets/australia 2026-10-15 https://www.pureglobal.com/markets/australia/artg-sponsor-manufacturer-evidence 2026-10-15 https://www.pureglobal.com/markets/bangladesh 2026-10-15 https://www.pureglobal.com/markets/brazil 2026-10-15 https://www.pureglobal.com/markets/brazil/ai-brazil-anvisa-submissions 2026-10-15 https://www.pureglobal.com/markets/brazil/anvisa-medical-device-classification 2026-10-15 https://www.pureglobal.com/markets/brazil/anvisa-medical-device-labeling 2026-10-15 https://www.pureglobal.com/markets/brazil/anvisa-medical-device-postmarket-surveillance 2026-10-15 https://www.pureglobal.com/markets/brazil/anvisa-medical-device-regulations 2026-10-15 https://www.pureglobal.com/markets/brazil/inmetro-anatel-medical-device-certification 2026-10-15 https://www.pureglobal.com/markets/canada 2026-10-15 https://www.pureglobal.com/markets/canada/medical-device-licence-mdl-vs-mdel 2026-10-15 https://www.pureglobal.com/markets/china China NMPA: Device Registration Routes https://www.pureglobal.com/assets/video-posters/Py5Uz9dIR02qXfIy7796D02yWaXwfVtG023CqZO2CL02gE00.jpg A video guide to NMPA device classes, registration routes, review clocks and China's medical device GMP framework. https://stream.mux.com/Py5Uz9dIR02qXfIy7796D02yWaXwfVtG023CqZO2CL02gE00.m3u8 https://player.mux.com/Py5Uz9dIR02qXfIy7796D02yWaXwfVtG023CqZO2CL02gE00?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FPy5Uz9dIR02qXfIy7796D02yWaXwfVtG023CqZO2CL02gE00.jpg&accent-color=%232451c6 115 2026-10-16T04:59:21.203Z 2026-10-15 https://www.pureglobal.com/markets/colombia 2026-10-15 https://www.pureglobal.com/markets/colombia/invima-medical-device-classification 2026-10-15 https://www.pureglobal.com/markets/colombia/invima-medical-device-labeling 2026-10-15 https://www.pureglobal.com/markets/colombia/invima-medical-device-postmarket-compliance 2026-10-15 https://www.pureglobal.com/markets/colombia/invima-medical-device-regulations 2026-10-15 https://www.pureglobal.com/markets/costa-rica 2026-10-15 https://www.pureglobal.com/markets/egypt 2026-10-15 https://www.pureglobal.com/markets/european-union 2026-10-15 https://www.pureglobal.com/markets/european-union/ce-mark-notified-body-search EU MDR: Choosing a Notified Body https://www.pureglobal.com/assets/video-posters/hm5Pl53mUXV00dpBZdTCSQ02AnNlLWYnTs2PIbnOEbGO00.jpg Learn how to use NANDO to check a notified body's designation and scope for your device under the EU MDR. https://stream.mux.com/hm5Pl53mUXV00dpBZdTCSQ02AnNlLWYnTs2PIbnOEbGO00.m3u8 https://player.mux.com/hm5Pl53mUXV00dpBZdTCSQ02AnNlLWYnTs2PIbnOEbGO00?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2Fhm5Pl53mUXV00dpBZdTCSQ02AnNlLWYnTs2PIbnOEbGO00.jpg&accent-color=%232451c6 104 2026-10-16T04:58:47.608Z 2026-10-15 https://www.pureglobal.com/markets/european-union/ec-european-authorized-representative EU Authorized Representatives: Article 11 https://www.pureglobal.com/assets/video-posters/8f2diZEFPEGBYwbxgEpcIL81gUNdow1kmcCTRB00WES4.jpg Learn when an EU authorized representative is needed and what MDR and IVDR Article 11 require. https://stream.mux.com/8f2diZEFPEGBYwbxgEpcIL81gUNdow1kmcCTRB00WES4.m3u8 https://player.mux.com/8f2diZEFPEGBYwbxgEpcIL81gUNdow1kmcCTRB00WES4?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F8f2diZEFPEGBYwbxgEpcIL81gUNdow1kmcCTRB00WES4.jpg&accent-color=%232451c6 100 2026-10-16T04:59:45.925Z 2026-10-15 https://www.pureglobal.com/markets/european-union/eu-ivdr-consulting 2026-10-15 https://www.pureglobal.com/markets/european-union/eu-ivdr-consulting/ce-marking-approval-for-ivds 2026-10-15 https://www.pureglobal.com/markets/european-union/eu-ivdr-consulting/ivdr-classification IVDR: Classes A–D and Transition Deadlines https://www.pureglobal.com/assets/video-posters/xFfNtUAJbK9nQD6IlZ41k13i47i2GVxwTtp2JBBYoVA.jpg Explore IVDR classification, Annex VIII rules and the legacy IVD transition deadlines covered in this video. https://stream.mux.com/xFfNtUAJbK9nQD6IlZ41k13i47i2GVxwTtp2JBBYoVA.m3u8 https://player.mux.com/xFfNtUAJbK9nQD6IlZ41k13i47i2GVxwTtp2JBBYoVA?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FxFfNtUAJbK9nQD6IlZ41k13i47i2GVxwTtp2JBBYoVA.jpg&accent-color=%232451c6 117 2026-10-16T04:59:40.284Z 2026-10-15 https://www.pureglobal.com/markets/european-union/eu-ivdr-consulting/ivdr-per-performance-evaluation-report 2026-10-15 https://www.pureglobal.com/markets/european-union/eu-ivdr-consulting/pmpf-postmarket-performance 2026-10-15 https://www.pureglobal.com/markets/european-union/eu-mdr-consulting 2026-10-15 https://www.pureglobal.com/markets/european-union/eu-mdr-consulting/eu-mdr-ce-marking-approval-for-medical-devices 2026-10-15 https://www.pureglobal.com/markets/european-union/eu-mdr-consulting/eu-mdr-classification-for-medical-devices EU MDR: Device Classification Rules https://www.pureglobal.com/assets/video-posters/E67JA1rg012v0002bCwrk6gZzbkcuT8EyFB19PUTqDzJMQ.jpg Learn how the 22 Annex VIII rules determine EU MDR device classes and how to apply the strictest relevant rule. https://stream.mux.com/E67JA1rg012v0002bCwrk6gZzbkcuT8EyFB19PUTqDzJMQ.m3u8 https://player.mux.com/E67JA1rg012v0002bCwrk6gZzbkcuT8EyFB19PUTqDzJMQ?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FE67JA1rg012v0002bCwrk6gZzbkcuT8EyFB19PUTqDzJMQ.jpg&accent-color=%232451c6 108 2026-10-16T04:59:27.006Z 2026-10-15 https://www.pureglobal.com/markets/european-union/eu-mdr-consulting/eu-mdr-clinical-evaluation-reports-cer-for-medical-devices EU MDR: Clinical Evaluation Reports https://www.pureglobal.com/assets/video-posters/teVFqOlFbuce01lKbdwr2d013lyRTQYKcsR7apvEpQMTI.jpg An introduction to the EU MDR clinical evaluation report, evidence requirements and keeping the CER up to date. https://stream.mux.com/teVFqOlFbuce01lKbdwr2d013lyRTQYKcsR7apvEpQMTI.m3u8 https://player.mux.com/teVFqOlFbuce01lKbdwr2d013lyRTQYKcsR7apvEpQMTI?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FteVFqOlFbuce01lKbdwr2d013lyRTQYKcsR7apvEpQMTI.jpg&accent-color=%232451c6 110 2026-10-16T04:59:53.863Z 2026-10-15 https://www.pureglobal.com/markets/european-union/eu-mdr-consulting/eu-pmcf-post-market-clinical-follow-up-for-medical-devices EU MDR PMCF: Plans, Reports and Timing https://www.pureglobal.com/assets/video-posters/MeeXg9C003BX00JkwSbbc1wtufRkp7btq3ZAbd1NDSxlo.jpg A guide to post-market clinical follow-up under the EU MDR, including PMCF plans, evaluation reports and timing. https://stream.mux.com/MeeXg9C003BX00JkwSbbc1wtufRkp7btq3ZAbd1NDSxlo.m3u8 https://player.mux.com/MeeXg9C003BX00JkwSbbc1wtufRkp7btq3ZAbd1NDSxlo?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FMeeXg9C003BX00JkwSbbc1wtufRkp7btq3ZAbd1NDSxlo.jpg&accent-color=%232451c6 108 2026-10-16T04:58:54.123Z 2026-10-15 https://www.pureglobal.com/markets/european-union/eu-mdr-gspr-checklist-annex-i 2026-10-15 https://www.pureglobal.com/markets/european-union/eu-mdr-ivdr-person-responsible-for-regulatory-compliance-prrc EU PRRC: Article 15 Requirements https://www.pureglobal.com/assets/video-posters/NcCR00V8nB5wmFTN7C1kJTBAa7Kmlmfi02ee7XwsMyuQM.jpg Understand the PRRC role under EU MDR and IVDR Article 15, including qualifications and responsibilities. https://stream.mux.com/NcCR00V8nB5wmFTN7C1kJTBAa7Kmlmfi02ee7XwsMyuQM.m3u8 https://player.mux.com/NcCR00V8nB5wmFTN7C1kJTBAa7Kmlmfi02ee7XwsMyuQM?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FNcCR00V8nB5wmFTN7C1kJTBAa7Kmlmfi02ee7XwsMyuQM.jpg&accent-color=%232451c6 108 2026-10-16T04:59:34.224Z 2026-10-15 https://www.pureglobal.com/markets/european-union/eu-mdr-psur-periodic-safety-update-report 2026-10-15 https://www.pureglobal.com/markets/european-union/eudamed-medical-device-ivd-registration 2026-10-15 https://www.pureglobal.com/markets/european-union/mdr-and-ivdr-postmarket-surveillance 2026-10-15 https://www.pureglobal.com/markets/hong-kong Hong Kong MDACS: Voluntary Listing https://www.pureglobal.com/assets/video-posters/01g3xtsRTru7Ig7A01vNe023Nr38jopQLEqTx6KLhqJ8RQ.jpg Explore Hong Kong's MDACS listing framework, the CMPR and the changes covered in this video. https://stream.mux.com/01g3xtsRTru7Ig7A01vNe023Nr38jopQLEqTx6KLhqJ8RQ.m3u8 https://player.mux.com/01g3xtsRTru7Ig7A01vNe023Nr38jopQLEqTx6KLhqJ8RQ?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F01g3xtsRTru7Ig7A01vNe023Nr38jopQLEqTx6KLhqJ8RQ.jpg&accent-color=%232451c6 101 2026-10-16T04:59:15.866Z 2026-10-15 https://www.pureglobal.com/markets/india 2026-10-15 https://www.pureglobal.com/markets/indonesia 2026-10-15 https://www.pureglobal.com/markets/indonesia/medical-device-classification 2026-10-15 https://www.pureglobal.com/markets/indonesia/medical-device-labeling 2026-10-15 https://www.pureglobal.com/markets/indonesia/medical-device-postmarket-requirements 2026-10-15 https://www.pureglobal.com/markets/indonesia/medical-device-regulations 2026-10-15 https://www.pureglobal.com/markets/israel 2026-10-15 https://www.pureglobal.com/markets/japan 2026-10-15 https://www.pureglobal.com/markets/japan/marketing-authorization-holder-mah-dmah 2026-10-15 https://www.pureglobal.com/markets/macau 2026-10-15 https://www.pureglobal.com/markets/malaysia 2026-10-15 https://www.pureglobal.com/markets/malaysia/mda-medical-device-classification 2026-10-15 https://www.pureglobal.com/markets/malaysia/mda-medical-device-labeling 2026-10-15 https://www.pureglobal.com/markets/malaysia/mda-medical-device-postmarket-requirements 2026-10-15 https://www.pureglobal.com/markets/malaysia/mda-medical-device-regulations 2026-10-15 https://www.pureglobal.com/markets/mexico 2026-10-15 https://www.pureglobal.com/markets/mexico/cofepris-medical-device-and-ivd-classification 2026-10-15 https://www.pureglobal.com/markets/mexico/cofepris-medical-device-labeling 2026-10-15 https://www.pureglobal.com/markets/mexico/cofepris-medical-device-postmarket-compliance 2026-10-15 https://www.pureglobal.com/markets/mexico/cofepris-medical-device-regulations 2026-10-15 https://www.pureglobal.com/markets/new-zealand 2026-10-15 https://www.pureglobal.com/markets/pakistan 2026-10-15 https://www.pureglobal.com/markets/peru Peru DIGEMID: Registration Times and Fees https://www.pureglobal.com/assets/video-posters/PgJluzdF01VY00Yazash8pKwFUhg8w02jyHeCw02sjh1VPM.jpg Learn about Peru's medical device registration routes and the DIGEMID review times and fees covered in this video. https://stream.mux.com/PgJluzdF01VY00Yazash8pKwFUhg8w02jyHeCw02sjh1VPM.m3u8 https://player.mux.com/PgJluzdF01VY00Yazash8pKwFUhg8w02jyHeCw02sjh1VPM?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FPgJluzdF01VY00Yazash8pKwFUhg8w02jyHeCw02sjh1VPM.jpg&accent-color=%232451c6 109 2026-10-16T05:00:08.644Z 2026-10-15 https://www.pureglobal.com/markets/philippines Philippines FDA: CMDN or CMDR? https://www.pureglobal.com/assets/video-posters/Hfkt6CXufVLkbOFBferCDgsxd0101j3BPO5R5ZQhxIdhU.jpg Understand the Philippine FDA's CMDN and CMDR pathways and the registration changes discussed in this video. https://stream.mux.com/Hfkt6CXufVLkbOFBferCDgsxd0101j3BPO5R5ZQhxIdhU.m3u8 https://player.mux.com/Hfkt6CXufVLkbOFBferCDgsxd0101j3BPO5R5ZQhxIdhU?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FHfkt6CXufVLkbOFBferCDgsxd0101j3BPO5R5ZQhxIdhU.jpg&accent-color=%232451c6 114 2026-10-16T04:59:00.292Z 2026-10-15 https://www.pureglobal.com/markets/saudi-arabia 2026-10-15 https://www.pureglobal.com/markets/singapore 2026-10-15 https://www.pureglobal.com/markets/singapore/hsa-medical-device-classification 2026-10-15 https://www.pureglobal.com/markets/singapore/hsa-medical-device-labeling 2026-10-15 https://www.pureglobal.com/markets/singapore/hsa-medical-device-postmarket-surveillance 2026-10-15 https://www.pureglobal.com/markets/singapore/hsa-medical-device-regulations 2026-10-15 https://www.pureglobal.com/markets/south-korea South Korea MFDS: Device Registration https://www.pureglobal.com/assets/video-posters/tRBfiLaVikYUQunZna7jnZgQOb81jfyeEhsQO78haX8.jpg Explore South Korea's device classes, MFDS registration routes, review clocks and five-year renewal. https://stream.mux.com/tRBfiLaVikYUQunZna7jnZgQOb81jfyeEhsQO78haX8.m3u8 https://player.mux.com/tRBfiLaVikYUQunZna7jnZgQOb81jfyeEhsQO78haX8?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FtRBfiLaVikYUQunZna7jnZgQOb81jfyeEhsQO78haX8.jpg&accent-color=%232451c6 104 2026-10-16T04:59:57.021Z 2026-10-15 https://www.pureglobal.com/markets/switzerland 2026-10-15 https://www.pureglobal.com/markets/taiwan 2026-10-15 https://www.pureglobal.com/markets/thailand 2026-10-15 https://www.pureglobal.com/markets/thailand/thailand-medical-device-and-ivd-classification 2026-10-15 https://www.pureglobal.com/markets/thailand/thailand-medical-device-and-ivd-labeling-requirements 2026-10-15 https://www.pureglobal.com/markets/thailand/thailand-medical-device-and-ivd-regulations 2026-10-15 https://www.pureglobal.com/markets/thailand/thailand-medical-device-post-market-requirements 2026-10-15 https://www.pureglobal.com/markets/uae 2026-10-15 https://www.pureglobal.com/markets/united-kingdom 2026-10-15 https://www.pureglobal.com/markets/united-kingdom/uk-responsible-person-medical-devices 2026-10-15 https://www.pureglobal.com/markets/united-states 2026-10-15 https://www.pureglobal.com/markets/united-states/fda-21-cfr-part-801-medical-device-labeling-and-iso-15223-symbols 2026-10-15 https://www.pureglobal.com/markets/united-states/fda-483-and-warning-letter-response-and-consulting FDA Form 483: Responses and Warning Letters https://www.pureglobal.com/assets/video-posters/binE4h84L7wmSv6V9M9p75OaUNQkD8H6oRA2pfQ4YYM.jpg Understand Form 483 observations, response timing, warning letters and FDA inspection outcomes. https://stream.mux.com/binE4h84L7wmSv6V9M9p75OaUNQkD8H6oRA2pfQ4YYM.m3u8 https://player.mux.com/binE4h84L7wmSv6V9M9p75OaUNQkD8H6oRA2pfQ4YYM?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FbinE4h84L7wmSv6V9M9p75OaUNQkD8H6oRA2pfQ4YYM.jpg&accent-color=%232451c6 108 2026-10-16T04:57:51.770Z 2026-10-15 https://www.pureglobal.com/markets/united-states/fda-biocompatibility-iso-10993-evaluation-guide 2026-10-15 https://www.pureglobal.com/markets/united-states/fda-certificate-to-foreign-government-cfg-for-medical-devices FDA CFG: Certificates for Device Exports https://www.pureglobal.com/assets/video-posters/fS276ccoWXokDxwtDforbRhDHmMWdtaxx67gerBBBeE.jpg Find out what an FDA Certificate to Foreign Government covers, when exporters may need it and how requests work. https://stream.mux.com/fS276ccoWXokDxwtDforbRhDHmMWdtaxx67gerBBBeE.m3u8 https://player.mux.com/fS276ccoWXokDxwtDforbRhDHmMWdtaxx67gerBBBeE?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FfS276ccoWXokDxwtDforbRhDHmMWdtaxx67gerBBBeE.jpg&accent-color=%232451c6 107 2026-10-16T04:58:42.168Z 2026-10-15 https://www.pureglobal.com/markets/united-states/fda-de-novo-classification-request 2026-10-15 https://www.pureglobal.com/markets/united-states/fda-estar-submission-template-guide 2026-10-15 https://www.pureglobal.com/markets/united-states/fda-ide-and-breakthrough-device-designation-guide 2026-10-15 https://www.pureglobal.com/markets/united-states/fda-medical-device-reporting-mdr-consulting FDA MDR: Medical Device Reporting https://www.pureglobal.com/assets/video-posters/AkU7r439f004ndRky18ENwIzhgrzkb28GCKrfrReVjYM.jpg An overview of 21 CFR 803, medical device reporting deadlines, five-day reports and electronic MDR submissions. https://stream.mux.com/AkU7r439f004ndRky18ENwIzhgrzkb28GCKrfrReVjYM.m3u8 https://player.mux.com/AkU7r439f004ndRky18ENwIzhgrzkb28GCKrfrReVjYM?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FAkU7r439f004ndRky18ENwIzhgrzkb28GCKrfrReVjYM.jpg&accent-color=%232451c6 109 2026-10-16T04:58:11.613Z 2026-10-15 https://www.pureglobal.com/markets/united-states/fda-pre-sub-guidance-and-q-sub-guidance-for-medical-devices FDA Pre-Sub: The Q-Submission Process https://www.pureglobal.com/assets/video-posters/be1w25SmygP8Eg02Vh3JuxdRmF8LXQyxZRgtgWwy01YUI.jpg Understand FDA Pre-Sub meetings, Q-Submission types, timelines and how to prepare focused questions. https://stream.mux.com/be1w25SmygP8Eg02Vh3JuxdRmF8LXQyxZRgtgWwy01YUI.m3u8 https://player.mux.com/be1w25SmygP8Eg02Vh3JuxdRmF8LXQyxZRgtgWwy01YUI?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2Fbe1w25SmygP8Eg02Vh3JuxdRmF8LXQyxZRgtgWwy01YUI.jpg&accent-color=%232451c6 105 2026-10-16T04:58:29.478Z 2026-10-15 https://www.pureglobal.com/markets/united-states/fda-premarket-approval-pma-submission-consulting-for-medical-devices FDA PMA: Premarket Approval Explained https://www.pureglobal.com/assets/video-posters/WEZQpF8YhdddbBNLteXLBkpxiekr4EqDJD39okgMqKg.jpg Learn when a device may need FDA premarket approval and how PMA evidence, fees and review clocks fit together. https://stream.mux.com/WEZQpF8YhdddbBNLteXLBkpxiekr4EqDJD39okgMqKg.m3u8 https://player.mux.com/WEZQpF8YhdddbBNLteXLBkpxiekr4EqDJD39okgMqKg?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FWEZQpF8YhdddbBNLteXLBkpxiekr4EqDJD39okgMqKg.jpg&accent-color=%232451c6 105 2026-10-16T04:59:06.512Z 2026-10-15 https://www.pureglobal.com/markets/united-states/fda-recognized-consensus-standards-and-doc-guide 2026-10-15 https://www.pureglobal.com/markets/united-states/fda-udi-and-gudid-database-submission-guide 2026-10-15 https://www.pureglobal.com/markets/united-states/us-fda-510k-clearance-submission-consulting FDA 510(k): Clearance and Submission https://www.pureglobal.com/assets/video-posters/9eLZMqKyqjKGI02yLiOYiSg9QwaewYbYkd2NVn00ZZJxg.jpg Explore substantial equivalence, predicates, eSTAR and the FDA 510(k) submission fees discussed in this video. https://stream.mux.com/9eLZMqKyqjKGI02yLiOYiSg9QwaewYbYkd2NVn00ZZJxg.m3u8 https://player.mux.com/9eLZMqKyqjKGI02yLiOYiSg9QwaewYbYkd2NVn00ZZJxg?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F9eLZMqKyqjKGI02yLiOYiSg9QwaewYbYkd2NVn00ZZJxg.jpg&accent-color=%232451c6 111 2026-10-16T04:58:34.086Z 2026-10-15 https://www.pureglobal.com/markets/united-states/us-fda-agent-for-medical-devices-companies 2026-10-15 https://www.pureglobal.com/markets/united-states/us-fda-medical-device-and-ivd-classification-consulting 2026-10-15 https://www.pureglobal.com/markets/united-states/us-fda-medical-device-establishment-registration-and-device-listing 2026-10-15 https://www.pureglobal.com/markets/united-states/us-fda-qmsr-consulting-for-medical-devices 2026-10-15 https://www.pureglobal.com/markets/vietnam 2026-10-15 https://www.pureglobal.com/markets/vietnam/vietnam-medical-device-and-ivd-classification-and-grouping 2026-10-15 https://www.pureglobal.com/markets/vietnam/vietnam-medical-device-and-ivd-post-market-requirements 2026-10-15 https://www.pureglobal.com/markets/vietnam/vietnam-medical-device-and-ivd-regulations 2026-10-15 https://www.pureglobal.com/markets/vietnam/vietnam-medical-device-labeling-requirements 2026-10-15 https://www.pureglobal.com/pt/markets 2026-06-17 https://www.pureglobal.com/pt/markets/argentina 2026-10-15 https://www.pureglobal.com/pt/markets/australia 2026-10-15 https://www.pureglobal.com/pt/markets/australia/artg-sponsor-manufacturer-evidence 2026-10-15 https://www.pureglobal.com/pt/markets/bangladesh 2026-10-15 https://www.pureglobal.com/pt/markets/brazil 2026-10-15 https://www.pureglobal.com/pt/markets/brazil/ai-brazil-anvisa-submissions 2026-10-15 https://www.pureglobal.com/pt/markets/brazil/anvisa-medical-device-classification 2026-10-15 https://www.pureglobal.com/pt/markets/brazil/anvisa-medical-device-labeling 2026-10-15 https://www.pureglobal.com/pt/markets/brazil/anvisa-medical-device-postmarket-surveillance 2026-10-15 https://www.pureglobal.com/pt/markets/brazil/anvisa-medical-device-regulations 2026-10-15 https://www.pureglobal.com/pt/markets/brazil/inmetro-anatel-medical-device-certification 2026-10-15 https://www.pureglobal.com/pt/markets/canada 2026-10-15 https://www.pureglobal.com/pt/markets/canada/medical-device-licence-mdl-vs-mdel 2026-10-15 https://www.pureglobal.com/pt/markets/china China e NMPA: Vias de Registro de Dispositivos https://www.pureglobal.com/assets/video-posters/Py5Uz9dIR02qXfIy7796D02yWaXwfVtG023CqZO2CL02gE00.jpg Guia em vídeo sobre classes de dispositivos da NMPA, vias de registro, prazos de análise e a estrutura de BPF da China. https://stream.mux.com/Py5Uz9dIR02qXfIy7796D02yWaXwfVtG023CqZO2CL02gE00.m3u8 https://player.mux.com/Py5Uz9dIR02qXfIy7796D02yWaXwfVtG023CqZO2CL02gE00?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FPy5Uz9dIR02qXfIy7796D02yWaXwfVtG023CqZO2CL02gE00.jpg&accent-color=%232451c6 115 2026-10-16T04:59:21.203Z 2026-10-15 https://www.pureglobal.com/pt/markets/colombia 2026-10-15 https://www.pureglobal.com/pt/markets/colombia/invima-medical-device-classification 2026-10-15 https://www.pureglobal.com/pt/markets/colombia/invima-medical-device-labeling 2026-10-15 https://www.pureglobal.com/pt/markets/colombia/invima-medical-device-postmarket-compliance 2026-10-15 https://www.pureglobal.com/pt/markets/colombia/invima-medical-device-regulations 2026-10-15 https://www.pureglobal.com/pt/markets/costa-rica 2026-10-15 https://www.pureglobal.com/pt/markets/egypt 2026-10-15 https://www.pureglobal.com/pt/markets/european-union 2026-10-15 https://www.pureglobal.com/pt/markets/european-union/ce-mark-notified-body-search MDR da UE: Escolhendo um Organismo Notificado https://www.pureglobal.com/assets/video-posters/hm5Pl53mUXV00dpBZdTCSQ02AnNlLWYnTs2PIbnOEbGO00.jpg Saiba como usar o NANDO para verificar a designação e o escopo de um organismo notificado para seu dispositivo sob o MDR da UE. https://stream.mux.com/hm5Pl53mUXV00dpBZdTCSQ02AnNlLWYnTs2PIbnOEbGO00.m3u8 https://player.mux.com/hm5Pl53mUXV00dpBZdTCSQ02AnNlLWYnTs2PIbnOEbGO00?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2Fhm5Pl53mUXV00dpBZdTCSQ02AnNlLWYnTs2PIbnOEbGO00.jpg&accent-color=%232451c6 104 2026-10-16T04:58:47.608Z 2026-10-15 https://www.pureglobal.com/pt/markets/european-union/ec-european-authorized-representative Representantes Autorizados da UE: Artigo 11 https://www.pureglobal.com/assets/video-posters/8f2diZEFPEGBYwbxgEpcIL81gUNdow1kmcCTRB00WES4.jpg Saiba quando um representante autorizado na UE é necessário e o que o Artigo 11 do MDR e do IVDR exige. https://stream.mux.com/8f2diZEFPEGBYwbxgEpcIL81gUNdow1kmcCTRB00WES4.m3u8 https://player.mux.com/8f2diZEFPEGBYwbxgEpcIL81gUNdow1kmcCTRB00WES4?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F8f2diZEFPEGBYwbxgEpcIL81gUNdow1kmcCTRB00WES4.jpg&accent-color=%232451c6 100 2026-10-16T04:59:45.925Z 2026-10-15 https://www.pureglobal.com/pt/markets/european-union/eu-ivdr-consulting 2026-10-15 https://www.pureglobal.com/pt/markets/european-union/eu-ivdr-consulting/ce-marking-approval-for-ivds 2026-10-15 https://www.pureglobal.com/pt/markets/european-union/eu-ivdr-consulting/ivdr-classification IVDR: Classes A–D e Prazos de Transição https://www.pureglobal.com/assets/video-posters/xFfNtUAJbK9nQD6IlZ41k13i47i2GVxwTtp2JBBYoVA.jpg Explore a classificação do IVDR, regras do Anexo VIII e os prazos de transição de IVDs legados abordados neste vídeo. https://stream.mux.com/xFfNtUAJbK9nQD6IlZ41k13i47i2GVxwTtp2JBBYoVA.m3u8 https://player.mux.com/xFfNtUAJbK9nQD6IlZ41k13i47i2GVxwTtp2JBBYoVA?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FxFfNtUAJbK9nQD6IlZ41k13i47i2GVxwTtp2JBBYoVA.jpg&accent-color=%232451c6 117 2026-10-16T04:59:40.284Z 2026-10-15 https://www.pureglobal.com/pt/markets/european-union/eu-ivdr-consulting/ivdr-per-performance-evaluation-report 2026-10-15 https://www.pureglobal.com/pt/markets/european-union/eu-ivdr-consulting/pmpf-postmarket-performance 2026-10-15 https://www.pureglobal.com/pt/markets/european-union/eu-mdr-consulting 2026-10-15 https://www.pureglobal.com/pt/markets/european-union/eu-mdr-consulting/eu-mdr-ce-marking-approval-for-medical-devices 2026-10-15 https://www.pureglobal.com/pt/markets/european-union/eu-mdr-consulting/eu-mdr-classification-for-medical-devices MDR da UE: Regras de Classificação de Dispositivos https://www.pureglobal.com/assets/video-posters/E67JA1rg012v0002bCwrk6gZzbkcuT8EyFB19PUTqDzJMQ.jpg Saiba como as 22 regras do Anexo VIII determinam as classes no MDR da UE e como aplicar a regra relevante mais restrita. https://stream.mux.com/E67JA1rg012v0002bCwrk6gZzbkcuT8EyFB19PUTqDzJMQ.m3u8 https://player.mux.com/E67JA1rg012v0002bCwrk6gZzbkcuT8EyFB19PUTqDzJMQ?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FE67JA1rg012v0002bCwrk6gZzbkcuT8EyFB19PUTqDzJMQ.jpg&accent-color=%232451c6 108 2026-10-16T04:59:27.006Z 2026-10-15 https://www.pureglobal.com/pt/markets/european-union/eu-mdr-consulting/eu-mdr-clinical-evaluation-reports-cer-for-medical-devices MDR da UE: Relatórios de Avaliação Clínica https://www.pureglobal.com/assets/video-posters/teVFqOlFbuce01lKbdwr2d013lyRTQYKcsR7apvEpQMTI.jpg Uma introdução ao relatório de avaliação clínica do MDR da UE, requisitos de evidência e como manter o CER atualizado. https://stream.mux.com/teVFqOlFbuce01lKbdwr2d013lyRTQYKcsR7apvEpQMTI.m3u8 https://player.mux.com/teVFqOlFbuce01lKbdwr2d013lyRTQYKcsR7apvEpQMTI?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FteVFqOlFbuce01lKbdwr2d013lyRTQYKcsR7apvEpQMTI.jpg&accent-color=%232451c6 110 2026-10-16T04:59:53.863Z 2026-10-15 https://www.pureglobal.com/pt/markets/european-union/eu-mdr-consulting/eu-pmcf-post-market-clinical-follow-up-for-medical-devices PMCF do MDR da UE: Planos, Relatórios e Prazos https://www.pureglobal.com/assets/video-posters/MeeXg9C003BX00JkwSbbc1wtufRkp7btq3ZAbd1NDSxlo.jpg Guia de acompanhamento clínico pós-mercado sob o MDR da UE, incluindo planos de PMCF, relatórios de avaliação e prazos. https://stream.mux.com/MeeXg9C003BX00JkwSbbc1wtufRkp7btq3ZAbd1NDSxlo.m3u8 https://player.mux.com/MeeXg9C003BX00JkwSbbc1wtufRkp7btq3ZAbd1NDSxlo?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FMeeXg9C003BX00JkwSbbc1wtufRkp7btq3ZAbd1NDSxlo.jpg&accent-color=%232451c6 108 2026-10-16T04:58:54.123Z 2026-10-15 https://www.pureglobal.com/pt/markets/european-union/eu-mdr-gspr-checklist-annex-i 2026-10-15 https://www.pureglobal.com/pt/markets/european-union/eu-mdr-ivdr-person-responsible-for-regulatory-compliance-prrc PRRC na UE: Requisitos do Artigo 15 https://www.pureglobal.com/assets/video-posters/NcCR00V8nB5wmFTN7C1kJTBAa7Kmlmfi02ee7XwsMyuQM.jpg Entenda a função da PRRC sob o Artigo 15 do MDR e do IVDR da UE, incluindo qualificações e responsabilidades. https://stream.mux.com/NcCR00V8nB5wmFTN7C1kJTBAa7Kmlmfi02ee7XwsMyuQM.m3u8 https://player.mux.com/NcCR00V8nB5wmFTN7C1kJTBAa7Kmlmfi02ee7XwsMyuQM?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FNcCR00V8nB5wmFTN7C1kJTBAa7Kmlmfi02ee7XwsMyuQM.jpg&accent-color=%232451c6 108 2026-10-16T04:59:34.224Z 2026-10-15 https://www.pureglobal.com/pt/markets/european-union/eu-mdr-psur-periodic-safety-update-report 2026-10-15 https://www.pureglobal.com/pt/markets/european-union/eudamed-medical-device-ivd-registration 2026-10-15 https://www.pureglobal.com/pt/markets/european-union/mdr-and-ivdr-postmarket-surveillance 2026-10-15 https://www.pureglobal.com/pt/markets/hong-kong MDACS de Hong Kong: Listagem Voluntária https://www.pureglobal.com/assets/video-posters/01g3xtsRTru7Ig7A01vNe023Nr38jopQLEqTx6KLhqJ8RQ.jpg Explore a estrutura de listagem do MDACS de Hong Kong, o CMPR e as mudanças abordadas neste vídeo. https://stream.mux.com/01g3xtsRTru7Ig7A01vNe023Nr38jopQLEqTx6KLhqJ8RQ.m3u8 https://player.mux.com/01g3xtsRTru7Ig7A01vNe023Nr38jopQLEqTx6KLhqJ8RQ?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F01g3xtsRTru7Ig7A01vNe023Nr38jopQLEqTx6KLhqJ8RQ.jpg&accent-color=%232451c6 101 2026-10-16T04:59:15.866Z 2026-10-15 https://www.pureglobal.com/pt/markets/india 2026-10-15 https://www.pureglobal.com/pt/markets/indonesia 2026-10-15 https://www.pureglobal.com/pt/markets/indonesia/medical-device-classification 2026-10-15 https://www.pureglobal.com/pt/markets/indonesia/medical-device-labeling 2026-10-15 https://www.pureglobal.com/pt/markets/indonesia/medical-device-postmarket-requirements 2026-10-15 https://www.pureglobal.com/pt/markets/indonesia/medical-device-regulations 2026-10-15 https://www.pureglobal.com/pt/markets/israel 2026-10-15 https://www.pureglobal.com/pt/markets/japan 2026-10-15 https://www.pureglobal.com/pt/markets/japan/marketing-authorization-holder-mah-dmah 2026-10-15 https://www.pureglobal.com/pt/markets/macau 2026-10-15 https://www.pureglobal.com/pt/markets/malaysia 2026-10-15 https://www.pureglobal.com/pt/markets/malaysia/mda-medical-device-classification 2026-10-15 https://www.pureglobal.com/pt/markets/malaysia/mda-medical-device-labeling 2026-10-15 https://www.pureglobal.com/pt/markets/malaysia/mda-medical-device-postmarket-requirements 2026-10-15 https://www.pureglobal.com/pt/markets/malaysia/mda-medical-device-regulations 2026-10-15 https://www.pureglobal.com/pt/markets/mexico 2026-10-15 https://www.pureglobal.com/pt/markets/mexico/cofepris-medical-device-and-ivd-classification 2026-10-15 https://www.pureglobal.com/pt/markets/mexico/cofepris-medical-device-labeling 2026-10-15 https://www.pureglobal.com/pt/markets/mexico/cofepris-medical-device-postmarket-compliance 2026-10-15 https://www.pureglobal.com/pt/markets/mexico/cofepris-medical-device-regulations 2026-10-15 https://www.pureglobal.com/pt/markets/new-zealand 2026-10-15 https://www.pureglobal.com/pt/markets/pakistan 2026-10-15 https://www.pureglobal.com/pt/markets/peru DIGEMID do Peru: Prazos de Registro e Taxas https://www.pureglobal.com/assets/video-posters/PgJluzdF01VY00Yazash8pKwFUhg8w02jyHeCw02sjh1VPM.jpg Conheça as vias de registro de dispositivos médicos no Peru e os prazos de análise e taxas da DIGEMID abordados neste vídeo. https://stream.mux.com/PgJluzdF01VY00Yazash8pKwFUhg8w02jyHeCw02sjh1VPM.m3u8 https://player.mux.com/PgJluzdF01VY00Yazash8pKwFUhg8w02jyHeCw02sjh1VPM?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FPgJluzdF01VY00Yazash8pKwFUhg8w02jyHeCw02sjh1VPM.jpg&accent-color=%232451c6 109 2026-10-16T05:00:08.644Z 2026-10-15 https://www.pureglobal.com/pt/markets/philippines FDA das Filipinas: CMDN ou CMDR? https://www.pureglobal.com/assets/video-posters/Hfkt6CXufVLkbOFBferCDgsxd0101j3BPO5R5ZQhxIdhU.jpg Entenda as vias CMDN e CMDR da FDA das Filipinas e as mudanças no registro abordadas neste vídeo. https://stream.mux.com/Hfkt6CXufVLkbOFBferCDgsxd0101j3BPO5R5ZQhxIdhU.m3u8 https://player.mux.com/Hfkt6CXufVLkbOFBferCDgsxd0101j3BPO5R5ZQhxIdhU?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FHfkt6CXufVLkbOFBferCDgsxd0101j3BPO5R5ZQhxIdhU.jpg&accent-color=%232451c6 114 2026-10-16T04:59:00.292Z 2026-10-15 https://www.pureglobal.com/pt/markets/saudi-arabia 2026-10-15 https://www.pureglobal.com/pt/markets/singapore 2026-10-15 https://www.pureglobal.com/pt/markets/singapore/hsa-medical-device-classification 2026-10-15 https://www.pureglobal.com/pt/markets/singapore/hsa-medical-device-labeling 2026-10-15 https://www.pureglobal.com/pt/markets/singapore/hsa-medical-device-postmarket-surveillance 2026-10-15 https://www.pureglobal.com/pt/markets/singapore/hsa-medical-device-regulations 2026-10-15 https://www.pureglobal.com/pt/markets/south-korea MFDS da Coreia do Sul: Registro de Dispositivos https://www.pureglobal.com/assets/video-posters/tRBfiLaVikYUQunZna7jnZgQOb81jfyeEhsQO78haX8.jpg Explore as classes de dispositivos da Coreia do Sul, vias de registro da MFDS, prazos de análise e renovação de 5 anos. https://stream.mux.com/tRBfiLaVikYUQunZna7jnZgQOb81jfyeEhsQO78haX8.m3u8 https://player.mux.com/tRBfiLaVikYUQunZna7jnZgQOb81jfyeEhsQO78haX8?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FtRBfiLaVikYUQunZna7jnZgQOb81jfyeEhsQO78haX8.jpg&accent-color=%232451c6 104 2026-10-16T04:59:57.021Z 2026-10-15 https://www.pureglobal.com/pt/markets/switzerland 2026-10-15 https://www.pureglobal.com/pt/markets/taiwan 2026-10-15 https://www.pureglobal.com/pt/markets/thailand 2026-10-15 https://www.pureglobal.com/pt/markets/thailand/thailand-medical-device-and-ivd-classification 2026-10-15 https://www.pureglobal.com/pt/markets/thailand/thailand-medical-device-and-ivd-labeling-requirements 2026-10-15 https://www.pureglobal.com/pt/markets/thailand/thailand-medical-device-and-ivd-regulations 2026-10-15 https://www.pureglobal.com/pt/markets/thailand/thailand-medical-device-post-market-requirements 2026-10-15 https://www.pureglobal.com/pt/markets/uae 2026-10-15 https://www.pureglobal.com/pt/markets/united-kingdom 2026-10-15 https://www.pureglobal.com/pt/markets/united-kingdom/uk-responsible-person-medical-devices 2026-10-15 https://www.pureglobal.com/pt/markets/united-states 2026-10-15 https://www.pureglobal.com/pt/markets/united-states/fda-21-cfr-part-801-medical-device-labeling-and-iso-15223-symbols 2026-10-15 https://www.pureglobal.com/pt/markets/united-states/fda-483-and-warning-letter-response-and-consulting FDA Form 483: Respostas e Warning Letters https://www.pureglobal.com/assets/video-posters/binE4h84L7wmSv6V9M9p75OaUNQkD8H6oRA2pfQ4YYM.jpg Entenda as observações do Form 483, prazos de resposta, warning letters e os resultados de inspeção da FDA. https://stream.mux.com/binE4h84L7wmSv6V9M9p75OaUNQkD8H6oRA2pfQ4YYM.m3u8 https://player.mux.com/binE4h84L7wmSv6V9M9p75OaUNQkD8H6oRA2pfQ4YYM?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FbinE4h84L7wmSv6V9M9p75OaUNQkD8H6oRA2pfQ4YYM.jpg&accent-color=%232451c6 108 2026-10-16T04:57:51.770Z 2026-10-15 https://www.pureglobal.com/pt/markets/united-states/fda-biocompatibility-iso-10993-evaluation-guide 2026-10-15 https://www.pureglobal.com/pt/markets/united-states/fda-certificate-to-foreign-government-cfg-for-medical-devices FDA CFG: Certificados de Exportação https://www.pureglobal.com/assets/video-posters/fS276ccoWXokDxwtDforbRhDHmMWdtaxx67gerBBBeE.jpg Saiba o que cobre o Certificate to Foreign Government da FDA, quando exportadores podem precisar dele e como funcionam as solicitações. https://stream.mux.com/fS276ccoWXokDxwtDforbRhDHmMWdtaxx67gerBBBeE.m3u8 https://player.mux.com/fS276ccoWXokDxwtDforbRhDHmMWdtaxx67gerBBBeE?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FfS276ccoWXokDxwtDforbRhDHmMWdtaxx67gerBBBeE.jpg&accent-color=%232451c6 107 2026-10-16T04:58:42.168Z 2026-10-15 https://www.pureglobal.com/pt/markets/united-states/fda-de-novo-classification-request 2026-10-15 https://www.pureglobal.com/pt/markets/united-states/fda-estar-submission-template-guide 2026-10-15 https://www.pureglobal.com/pt/markets/united-states/fda-ide-and-breakthrough-device-designation-guide 2026-10-15 https://www.pureglobal.com/pt/markets/united-states/fda-medical-device-reporting-mdr-consulting FDA MDR: Notificação de Dispositivos https://www.pureglobal.com/assets/video-posters/AkU7r439f004ndRky18ENwIzhgrzkb28GCKrfrReVjYM.jpg Visão geral de 21 CFR 803, prazos de notificação de dispositivos, relatórios de cinco dias e submissões eletrônicas de MDR. https://stream.mux.com/AkU7r439f004ndRky18ENwIzhgrzkb28GCKrfrReVjYM.m3u8 https://player.mux.com/AkU7r439f004ndRky18ENwIzhgrzkb28GCKrfrReVjYM?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FAkU7r439f004ndRky18ENwIzhgrzkb28GCKrfrReVjYM.jpg&accent-color=%232451c6 109 2026-10-16T04:58:11.613Z 2026-10-15 https://www.pureglobal.com/pt/markets/united-states/fda-pre-sub-guidance-and-q-sub-guidance-for-medical-devices FDA Pre-Sub: Processo de Q-Submission https://www.pureglobal.com/assets/video-posters/be1w25SmygP8Eg02Vh3JuxdRmF8LXQyxZRgtgWwy01YUI.jpg Entenda as reuniões de Pre-Sub da FDA, tipos de Q-Submission, prazos e como elaborar perguntas direcionadas. https://stream.mux.com/be1w25SmygP8Eg02Vh3JuxdRmF8LXQyxZRgtgWwy01YUI.m3u8 https://player.mux.com/be1w25SmygP8Eg02Vh3JuxdRmF8LXQyxZRgtgWwy01YUI?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2Fbe1w25SmygP8Eg02Vh3JuxdRmF8LXQyxZRgtgWwy01YUI.jpg&accent-color=%232451c6 105 2026-10-16T04:58:29.478Z 2026-10-15 https://www.pureglobal.com/pt/markets/united-states/fda-premarket-approval-pma-submission-consulting-for-medical-devices PMA da FDA: Aprovação Pré-Mercado https://www.pureglobal.com/assets/video-posters/WEZQpF8YhdddbBNLteXLBkpxiekr4EqDJD39okgMqKg.jpg Saiba quando um dispositivo pode precisar de aprovação pré-mercado da FDA e como evidências de PMA, taxas e prazos de análise se articulam. https://stream.mux.com/WEZQpF8YhdddbBNLteXLBkpxiekr4EqDJD39okgMqKg.m3u8 https://player.mux.com/WEZQpF8YhdddbBNLteXLBkpxiekr4EqDJD39okgMqKg?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FWEZQpF8YhdddbBNLteXLBkpxiekr4EqDJD39okgMqKg.jpg&accent-color=%232451c6 105 2026-10-16T04:59:06.512Z 2026-10-15 https://www.pureglobal.com/pt/markets/united-states/fda-recognized-consensus-standards-and-doc-guide 2026-10-15 https://www.pureglobal.com/pt/markets/united-states/fda-udi-and-gudid-database-submission-guide 2026-10-15 https://www.pureglobal.com/pt/markets/united-states/us-fda-510k-clearance-submission-consulting FDA 510(k): Liberação e Submissão https://www.pureglobal.com/assets/video-posters/9eLZMqKyqjKGI02yLiOYiSg9QwaewYbYkd2NVn00ZZJxg.jpg Explore equivalência substancial, predicados, eSTAR e as taxas de submissão do FDA 510(k) abordadas neste vídeo. https://stream.mux.com/9eLZMqKyqjKGI02yLiOYiSg9QwaewYbYkd2NVn00ZZJxg.m3u8 https://player.mux.com/9eLZMqKyqjKGI02yLiOYiSg9QwaewYbYkd2NVn00ZZJxg?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F9eLZMqKyqjKGI02yLiOYiSg9QwaewYbYkd2NVn00ZZJxg.jpg&accent-color=%232451c6 111 2026-10-16T04:58:34.086Z 2026-10-15 https://www.pureglobal.com/pt/markets/united-states/us-fda-agent-for-medical-devices-companies 2026-10-15 https://www.pureglobal.com/pt/markets/united-states/us-fda-medical-device-and-ivd-classification-consulting 2026-10-15 https://www.pureglobal.com/pt/markets/united-states/us-fda-medical-device-establishment-registration-and-device-listing 2026-10-15 https://www.pureglobal.com/pt/markets/united-states/us-fda-qmsr-consulting-for-medical-devices 2026-10-15 https://www.pureglobal.com/pt/markets/vietnam 2026-10-15 https://www.pureglobal.com/pt/markets/vietnam/vietnam-medical-device-and-ivd-classification-and-grouping 2026-10-15 https://www.pureglobal.com/pt/markets/vietnam/vietnam-medical-device-and-ivd-post-market-requirements 2026-10-15 https://www.pureglobal.com/pt/markets/vietnam/vietnam-medical-device-and-ivd-regulations 2026-10-15 https://www.pureglobal.com/pt/markets/vietnam/vietnam-medical-device-labeling-requirements 2026-10-15 https://www.pureglobal.com/zh/markets 2026-06-17 https://www.pureglobal.com/zh/markets/argentina 2026-10-15 https://www.pureglobal.com/zh/markets/australia 2026-10-15 https://www.pureglobal.com/zh/markets/australia/artg-sponsor-manufacturer-evidence 2026-10-15 https://www.pureglobal.com/zh/markets/bangladesh 2026-10-15 https://www.pureglobal.com/zh/markets/brazil 2026-10-15 https://www.pureglobal.com/zh/markets/brazil/ai-brazil-anvisa-submissions 2026-10-15 https://www.pureglobal.com/zh/markets/brazil/anvisa-medical-device-classification 2026-10-15 https://www.pureglobal.com/zh/markets/brazil/anvisa-medical-device-labeling 2026-10-15 https://www.pureglobal.com/zh/markets/brazil/anvisa-medical-device-postmarket-surveillance 2026-10-15 https://www.pureglobal.com/zh/markets/brazil/anvisa-medical-device-regulations 2026-10-15 https://www.pureglobal.com/zh/markets/brazil/inmetro-anatel-medical-device-certification 2026-10-15 https://www.pureglobal.com/zh/markets/canada 2026-10-15 https://www.pureglobal.com/zh/markets/canada/medical-device-licence-mdl-vs-mdel 2026-10-15 https://www.pureglobal.com/zh/markets/china 中国NMPA：器械注册路径 https://www.pureglobal.com/assets/video-posters/Py5Uz9dIR02qXfIy7796D02yWaXwfVtG023CqZO2CL02gE00.jpg 关于NMPA器械分类、注册路径、审评时限及中国医疗器械GMP规范框架的视频指南。 https://stream.mux.com/Py5Uz9dIR02qXfIy7796D02yWaXwfVtG023CqZO2CL02gE00.m3u8 https://player.mux.com/Py5Uz9dIR02qXfIy7796D02yWaXwfVtG023CqZO2CL02gE00?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FPy5Uz9dIR02qXfIy7796D02yWaXwfVtG023CqZO2CL02gE00.jpg&accent-color=%232451c6 115 2026-10-16T04:59:21.203Z 2026-10-15 https://www.pureglobal.com/zh/markets/colombia 2026-10-15 https://www.pureglobal.com/zh/markets/colombia/invima-medical-device-classification 2026-10-15 https://www.pureglobal.com/zh/markets/colombia/invima-medical-device-labeling 2026-10-15 https://www.pureglobal.com/zh/markets/colombia/invima-medical-device-postmarket-compliance 2026-10-15 https://www.pureglobal.com/zh/markets/colombia/invima-medical-device-regulations 2026-10-15 https://www.pureglobal.com/zh/markets/costa-rica 2026-10-15 https://www.pureglobal.com/zh/markets/egypt 2026-10-15 https://www.pureglobal.com/zh/markets/european-union 2026-10-15 https://www.pureglobal.com/zh/markets/european-union/ce-mark-notified-body-search 欧盟MDR：选择公告机构 https://www.pureglobal.com/assets/video-posters/hm5Pl53mUXV00dpBZdTCSQ02AnNlLWYnTs2PIbnOEbGO00.jpg 了解如何使用NANDO查询欧盟MDR下公告机构的指定资格及针对您器械的业务范围。 https://stream.mux.com/hm5Pl53mUXV00dpBZdTCSQ02AnNlLWYnTs2PIbnOEbGO00.m3u8 https://player.mux.com/hm5Pl53mUXV00dpBZdTCSQ02AnNlLWYnTs2PIbnOEbGO00?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2Fhm5Pl53mUXV00dpBZdTCSQ02AnNlLWYnTs2PIbnOEbGO00.jpg&accent-color=%232451c6 104 2026-10-16T04:58:47.608Z 2026-10-15 https://www.pureglobal.com/zh/markets/european-union/ec-european-authorized-representative 欧盟授权代表：第11条 https://www.pureglobal.com/assets/video-posters/8f2diZEFPEGBYwbxgEpcIL81gUNdow1kmcCTRB00WES4.jpg 了解何时需要欧盟授权代表，以及MDR与IVDR第11条的具体要求。 https://stream.mux.com/8f2diZEFPEGBYwbxgEpcIL81gUNdow1kmcCTRB00WES4.m3u8 https://player.mux.com/8f2diZEFPEGBYwbxgEpcIL81gUNdow1kmcCTRB00WES4?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F8f2diZEFPEGBYwbxgEpcIL81gUNdow1kmcCTRB00WES4.jpg&accent-color=%232451c6 100 2026-10-16T04:59:45.925Z 2026-10-15 https://www.pureglobal.com/zh/markets/european-union/eu-ivdr-consulting 2026-10-15 https://www.pureglobal.com/zh/markets/european-union/eu-ivdr-consulting/ce-marking-approval-for-ivds 2026-10-15 https://www.pureglobal.com/zh/markets/european-union/eu-ivdr-consulting/ivdr-classification IVDR：A–D类分类与过渡期截止日 https://www.pureglobal.com/assets/video-posters/xFfNtUAJbK9nQD6IlZ41k13i47i2GVxwTtp2JBBYoVA.jpg 了解本视频涵盖的IVDR分类、附录VIII规则以及遗留IVD过渡期截止日期。 https://stream.mux.com/xFfNtUAJbK9nQD6IlZ41k13i47i2GVxwTtp2JBBYoVA.m3u8 https://player.mux.com/xFfNtUAJbK9nQD6IlZ41k13i47i2GVxwTtp2JBBYoVA?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FxFfNtUAJbK9nQD6IlZ41k13i47i2GVxwTtp2JBBYoVA.jpg&accent-color=%232451c6 117 2026-10-16T04:59:40.284Z 2026-10-15 https://www.pureglobal.com/zh/markets/european-union/eu-ivdr-consulting/ivdr-per-performance-evaluation-report 2026-10-15 https://www.pureglobal.com/zh/markets/european-union/eu-ivdr-consulting/pmpf-postmarket-performance 2026-10-15 https://www.pureglobal.com/zh/markets/european-union/eu-mdr-consulting 2026-10-15 https://www.pureglobal.com/zh/markets/european-union/eu-mdr-consulting/eu-mdr-ce-marking-approval-for-medical-devices 2026-10-15 https://www.pureglobal.com/zh/markets/european-union/eu-mdr-consulting/eu-mdr-classification-for-medical-devices 欧盟MDR：器械分类规则 https://www.pureglobal.com/assets/video-posters/E67JA1rg012v0002bCwrk6gZzbkcuT8EyFB19PUTqDzJMQ.jpg 了解附录VIII中的22条规则如何确定欧盟MDR器械分类，以及如何适用最严格的相关规则。 https://stream.mux.com/E67JA1rg012v0002bCwrk6gZzbkcuT8EyFB19PUTqDzJMQ.m3u8 https://player.mux.com/E67JA1rg012v0002bCwrk6gZzbkcuT8EyFB19PUTqDzJMQ?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FE67JA1rg012v0002bCwrk6gZzbkcuT8EyFB19PUTqDzJMQ.jpg&accent-color=%232451c6 108 2026-10-16T04:59:27.006Z 2026-10-15 https://www.pureglobal.com/zh/markets/european-union/eu-mdr-consulting/eu-mdr-clinical-evaluation-reports-cer-for-medical-devices 欧盟MDR：临床评价报告 https://www.pureglobal.com/assets/video-posters/teVFqOlFbuce01lKbdwr2d013lyRTQYKcsR7apvEpQMTI.jpg 介绍欧盟MDR临床评价报告、证据要求以及如何保持CER的持续更新。 https://stream.mux.com/teVFqOlFbuce01lKbdwr2d013lyRTQYKcsR7apvEpQMTI.m3u8 https://player.mux.com/teVFqOlFbuce01lKbdwr2d013lyRTQYKcsR7apvEpQMTI?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FteVFqOlFbuce01lKbdwr2d013lyRTQYKcsR7apvEpQMTI.jpg&accent-color=%232451c6 110 2026-10-16T04:59:53.863Z 2026-10-15 https://www.pureglobal.com/zh/markets/european-union/eu-mdr-consulting/eu-pmcf-post-market-clinical-follow-up-for-medical-devices 欧盟MDR PMCF：计划、报告与时限 https://www.pureglobal.com/assets/video-posters/MeeXg9C003BX00JkwSbbc1wtufRkp7btq3ZAbd1NDSxlo.jpg 欧盟MDR上市后临床跟踪指南，涵盖PMCF计划、评价报告及时间节点要求。 https://stream.mux.com/MeeXg9C003BX00JkwSbbc1wtufRkp7btq3ZAbd1NDSxlo.m3u8 https://player.mux.com/MeeXg9C003BX00JkwSbbc1wtufRkp7btq3ZAbd1NDSxlo?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FMeeXg9C003BX00JkwSbbc1wtufRkp7btq3ZAbd1NDSxlo.jpg&accent-color=%232451c6 108 2026-10-16T04:58:54.123Z 2026-10-15 https://www.pureglobal.com/zh/markets/european-union/eu-mdr-gspr-checklist-annex-i 2026-10-15 https://www.pureglobal.com/zh/markets/european-union/eu-mdr-ivdr-person-responsible-for-regulatory-compliance-prrc 欧盟PRRC：第15条要求 https://www.pureglobal.com/assets/video-posters/NcCR00V8nB5wmFTN7C1kJTBAa7Kmlmfi02ee7XwsMyuQM.jpg 了解欧盟MDR与IVDR第15条项下的PRRC角色，包括其资质要求与职责。 https://stream.mux.com/NcCR00V8nB5wmFTN7C1kJTBAa7Kmlmfi02ee7XwsMyuQM.m3u8 https://player.mux.com/NcCR00V8nB5wmFTN7C1kJTBAa7Kmlmfi02ee7XwsMyuQM?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FNcCR00V8nB5wmFTN7C1kJTBAa7Kmlmfi02ee7XwsMyuQM.jpg&accent-color=%232451c6 108 2026-10-16T04:59:34.224Z 2026-10-15 https://www.pureglobal.com/zh/markets/european-union/eu-mdr-psur-periodic-safety-update-report 2026-10-15 https://www.pureglobal.com/zh/markets/european-union/eudamed-medical-device-ivd-registration 2026-10-15 https://www.pureglobal.com/zh/markets/european-union/mdr-and-ivdr-postmarket-surveillance 2026-10-15 https://www.pureglobal.com/zh/markets/hong-kong 香港MDACS：自愿性表列 https://www.pureglobal.com/assets/video-posters/01g3xtsRTru7Ig7A01vNe023Nr38jopQLEqTx6KLhqJ8RQ.jpg 探讨香港MDACS表列制度框架、CMPR以及本视频涵盖的各项变更。 https://stream.mux.com/01g3xtsRTru7Ig7A01vNe023Nr38jopQLEqTx6KLhqJ8RQ.m3u8 https://player.mux.com/01g3xtsRTru7Ig7A01vNe023Nr38jopQLEqTx6KLhqJ8RQ?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F01g3xtsRTru7Ig7A01vNe023Nr38jopQLEqTx6KLhqJ8RQ.jpg&accent-color=%232451c6 101 2026-10-16T04:59:15.866Z 2026-10-15 https://www.pureglobal.com/zh/markets/india 2026-10-15 https://www.pureglobal.com/zh/markets/indonesia 2026-10-15 https://www.pureglobal.com/zh/markets/indonesia/medical-device-classification 2026-10-15 https://www.pureglobal.com/zh/markets/indonesia/medical-device-labeling 2026-10-15 https://www.pureglobal.com/zh/markets/indonesia/medical-device-postmarket-requirements 2026-10-15 https://www.pureglobal.com/zh/markets/indonesia/medical-device-regulations 2026-10-15 https://www.pureglobal.com/zh/markets/israel 2026-10-15 https://www.pureglobal.com/zh/markets/japan 2026-10-15 https://www.pureglobal.com/zh/markets/japan/marketing-authorization-holder-mah-dmah 2026-10-15 https://www.pureglobal.com/zh/markets/macau 2026-10-15 https://www.pureglobal.com/zh/markets/malaysia 2026-10-15 https://www.pureglobal.com/zh/markets/malaysia/mda-medical-device-classification 2026-10-15 https://www.pureglobal.com/zh/markets/malaysia/mda-medical-device-labeling 2026-10-15 https://www.pureglobal.com/zh/markets/malaysia/mda-medical-device-postmarket-requirements 2026-10-15 https://www.pureglobal.com/zh/markets/malaysia/mda-medical-device-regulations 2026-10-15 https://www.pureglobal.com/zh/markets/mexico 2026-10-15 https://www.pureglobal.com/zh/markets/mexico/cofepris-medical-device-and-ivd-classification 2026-10-15 https://www.pureglobal.com/zh/markets/mexico/cofepris-medical-device-labeling 2026-10-15 https://www.pureglobal.com/zh/markets/mexico/cofepris-medical-device-postmarket-compliance 2026-10-15 https://www.pureglobal.com/zh/markets/mexico/cofepris-medical-device-regulations 2026-10-15 https://www.pureglobal.com/zh/markets/new-zealand 2026-10-15 https://www.pureglobal.com/zh/markets/pakistan 2026-10-15 https://www.pureglobal.com/zh/markets/peru 秘鲁DIGEMID：注册周期与费用 https://www.pureglobal.com/assets/video-posters/PgJluzdF01VY00Yazash8pKwFUhg8w02jyHeCw02sjh1VPM.jpg 了解秘鲁医疗器械注册路径，以及本视频涵盖的DIGEMID审评时限与费用。 https://stream.mux.com/PgJluzdF01VY00Yazash8pKwFUhg8w02jyHeCw02sjh1VPM.m3u8 https://player.mux.com/PgJluzdF01VY00Yazash8pKwFUhg8w02jyHeCw02sjh1VPM?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FPgJluzdF01VY00Yazash8pKwFUhg8w02jyHeCw02sjh1VPM.jpg&accent-color=%232451c6 109 2026-10-16T05:00:08.644Z 2026-10-15 https://www.pureglobal.com/zh/markets/philippines 菲律宾FDA：CMDN还是CMDR？ https://www.pureglobal.com/assets/video-posters/Hfkt6CXufVLkbOFBferCDgsxd0101j3BPO5R5ZQhxIdhU.jpg 了解菲律宾FDA的CMDN与CMDR路径，以及本视频讨论的注册变更。 https://stream.mux.com/Hfkt6CXufVLkbOFBferCDgsxd0101j3BPO5R5ZQhxIdhU.m3u8 https://player.mux.com/Hfkt6CXufVLkbOFBferCDgsxd0101j3BPO5R5ZQhxIdhU?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FHfkt6CXufVLkbOFBferCDgsxd0101j3BPO5R5ZQhxIdhU.jpg&accent-color=%232451c6 114 2026-10-16T04:59:00.292Z 2026-10-15 https://www.pureglobal.com/zh/markets/saudi-arabia 2026-10-15 https://www.pureglobal.com/zh/markets/singapore 2026-10-15 https://www.pureglobal.com/zh/markets/singapore/hsa-medical-device-classification 2026-10-15 https://www.pureglobal.com/zh/markets/singapore/hsa-medical-device-labeling 2026-10-15 https://www.pureglobal.com/zh/markets/singapore/hsa-medical-device-postmarket-surveillance 2026-10-15 https://www.pureglobal.com/zh/markets/singapore/hsa-medical-device-regulations 2026-10-15 https://www.pureglobal.com/zh/markets/south-korea 韩国MFDS：器械注册 https://www.pureglobal.com/assets/video-posters/tRBfiLaVikYUQunZna7jnZgQOb81jfyeEhsQO78haX8.jpg 了解韩国医疗器械分类、MFDS注册路径、审评时限及五年期延续注册。 https://stream.mux.com/tRBfiLaVikYUQunZna7jnZgQOb81jfyeEhsQO78haX8.m3u8 https://player.mux.com/tRBfiLaVikYUQunZna7jnZgQOb81jfyeEhsQO78haX8?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FtRBfiLaVikYUQunZna7jnZgQOb81jfyeEhsQO78haX8.jpg&accent-color=%232451c6 104 2026-10-16T04:59:57.021Z 2026-10-15 https://www.pureglobal.com/zh/markets/switzerland 2026-10-15 https://www.pureglobal.com/zh/markets/taiwan 2026-10-15 https://www.pureglobal.com/zh/markets/thailand 2026-10-15 https://www.pureglobal.com/zh/markets/thailand/thailand-medical-device-and-ivd-classification 2026-10-15 https://www.pureglobal.com/zh/markets/thailand/thailand-medical-device-and-ivd-labeling-requirements 2026-10-15 https://www.pureglobal.com/zh/markets/thailand/thailand-medical-device-and-ivd-regulations 2026-10-15 https://www.pureglobal.com/zh/markets/thailand/thailand-medical-device-post-market-requirements 2026-10-15 https://www.pureglobal.com/zh/markets/uae 2026-10-15 https://www.pureglobal.com/zh/markets/united-kingdom 2026-10-15 https://www.pureglobal.com/zh/markets/united-kingdom/uk-responsible-person-medical-devices 2026-10-15 https://www.pureglobal.com/zh/markets/united-states 2026-10-15 https://www.pureglobal.com/zh/markets/united-states/fda-21-cfr-part-801-medical-device-labeling-and-iso-15223-symbols 2026-10-15 https://www.pureglobal.com/zh/markets/united-states/fda-483-and-warning-letter-response-and-consulting FDA Form 483：回复与警告信 https://www.pureglobal.com/assets/video-posters/binE4h84L7wmSv6V9M9p75OaUNQkD8H6oRA2pfQ4YYM.jpg 了解Form 483观察项、回复时限、警告信以及FDA检查结果。 https://stream.mux.com/binE4h84L7wmSv6V9M9p75OaUNQkD8H6oRA2pfQ4YYM.m3u8 https://player.mux.com/binE4h84L7wmSv6V9M9p75OaUNQkD8H6oRA2pfQ4YYM?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FbinE4h84L7wmSv6V9M9p75OaUNQkD8H6oRA2pfQ4YYM.jpg&accent-color=%232451c6 108 2026-10-16T04:57:51.770Z 2026-10-15 https://www.pureglobal.com/zh/markets/united-states/fda-biocompatibility-iso-10993-evaluation-guide 2026-10-15 https://www.pureglobal.com/zh/markets/united-states/fda-certificate-to-foreign-government-cfg-for-medical-devices FDA CFG：器械出口证书 https://www.pureglobal.com/assets/video-posters/fS276ccoWXokDxwtDforbRhDHmMWdtaxx67gerBBBeE.jpg 了解FDA境外政府证书涵盖的内容、出口商何时可能需要该证书以及申请流程。 https://stream.mux.com/fS276ccoWXokDxwtDforbRhDHmMWdtaxx67gerBBBeE.m3u8 https://player.mux.com/fS276ccoWXokDxwtDforbRhDHmMWdtaxx67gerBBBeE?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FfS276ccoWXokDxwtDforbRhDHmMWdtaxx67gerBBBeE.jpg&accent-color=%232451c6 107 2026-10-16T04:58:42.168Z 2026-10-15 https://www.pureglobal.com/zh/markets/united-states/fda-de-novo-classification-request 2026-10-15 https://www.pureglobal.com/zh/markets/united-states/fda-estar-submission-template-guide 2026-10-15 https://www.pureglobal.com/zh/markets/united-states/fda-ide-and-breakthrough-device-designation-guide 2026-10-15 https://www.pureglobal.com/zh/markets/united-states/fda-medical-device-reporting-mdr-consulting FDA MDR：医疗器械不良事件报告 https://www.pureglobal.com/assets/video-posters/AkU7r439f004ndRky18ENwIzhgrzkb28GCKrfrReVjYM.jpg 概述21 CFR 803、医疗器械不良事件报告时限、5日报告及电子MDR递交。 https://stream.mux.com/AkU7r439f004ndRky18ENwIzhgrzkb28GCKrfrReVjYM.m3u8 https://player.mux.com/AkU7r439f004ndRky18ENwIzhgrzkb28GCKrfrReVjYM?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FAkU7r439f004ndRky18ENwIzhgrzkb28GCKrfrReVjYM.jpg&accent-color=%232451c6 109 2026-10-16T04:58:11.613Z 2026-10-15 https://www.pureglobal.com/zh/markets/united-states/fda-pre-sub-guidance-and-q-sub-guidance-for-medical-devices FDA Pre-Sub：Q-Submission流程 https://www.pureglobal.com/assets/video-posters/be1w25SmygP8Eg02Vh3JuxdRmF8LXQyxZRgtgWwy01YUI.jpg 了解FDA Pre-Sub会议、Q-Submission类型、时限要求以及如何准备针对性问题。 https://stream.mux.com/be1w25SmygP8Eg02Vh3JuxdRmF8LXQyxZRgtgWwy01YUI.m3u8 https://player.mux.com/be1w25SmygP8Eg02Vh3JuxdRmF8LXQyxZRgtgWwy01YUI?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2Fbe1w25SmygP8Eg02Vh3JuxdRmF8LXQyxZRgtgWwy01YUI.jpg&accent-color=%232451c6 105 2026-10-16T04:58:29.478Z 2026-10-15 https://www.pureglobal.com/zh/markets/united-states/fda-premarket-approval-pma-submission-consulting-for-medical-devices FDA PMA：上市前批准解析 https://www.pureglobal.com/assets/video-posters/WEZQpF8YhdddbBNLteXLBkpxiekr4EqDJD39okgMqKg.jpg 了解器械何时可能需要FDA上市前批准，以及PMA证据、费用与审评时限的相互关联。 https://stream.mux.com/WEZQpF8YhdddbBNLteXLBkpxiekr4EqDJD39okgMqKg.m3u8 https://player.mux.com/WEZQpF8YhdddbBNLteXLBkpxiekr4EqDJD39okgMqKg?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FWEZQpF8YhdddbBNLteXLBkpxiekr4EqDJD39okgMqKg.jpg&accent-color=%232451c6 105 2026-10-16T04:59:06.512Z 2026-10-15 https://www.pureglobal.com/zh/markets/united-states/fda-recognized-consensus-standards-and-doc-guide 2026-10-15 https://www.pureglobal.com/zh/markets/united-states/fda-udi-and-gudid-database-submission-guide 2026-10-15 https://www.pureglobal.com/zh/markets/united-states/us-fda-510k-clearance-submission-consulting FDA 510(k)：许可与申报 https://www.pureglobal.com/assets/video-posters/9eLZMqKyqjKGI02yLiOYiSg9QwaewYbYkd2NVn00ZZJxg.jpg 探讨本视频中讨论的实质等同性、对比器械、eSTAR以及FDA 510(k)申报费用。 https://stream.mux.com/9eLZMqKyqjKGI02yLiOYiSg9QwaewYbYkd2NVn00ZZJxg.m3u8 https://player.mux.com/9eLZMqKyqjKGI02yLiOYiSg9QwaewYbYkd2NVn00ZZJxg?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F9eLZMqKyqjKGI02yLiOYiSg9QwaewYbYkd2NVn00ZZJxg.jpg&accent-color=%232451c6 111 2026-10-16T04:58:34.086Z 2026-10-15 https://www.pureglobal.com/zh/markets/united-states/us-fda-agent-for-medical-devices-companies 2026-10-15 https://www.pureglobal.com/zh/markets/united-states/us-fda-medical-device-and-ivd-classification-consulting 2026-10-15 https://www.pureglobal.com/zh/markets/united-states/us-fda-medical-device-establishment-registration-and-device-listing 2026-10-15 https://www.pureglobal.com/zh/markets/united-states/us-fda-qmsr-consulting-for-medical-devices 2026-10-15 https://www.pureglobal.com/zh/markets/vietnam 2026-10-15 https://www.pureglobal.com/zh/markets/vietnam/vietnam-medical-device-and-ivd-classification-and-grouping 2026-10-15 https://www.pureglobal.com/zh/markets/vietnam/vietnam-medical-device-and-ivd-post-market-requirements 2026-10-15 https://www.pureglobal.com/zh/markets/vietnam/vietnam-medical-device-and-ivd-regulations 2026-10-15 https://www.pureglobal.com/zh/markets/vietnam/vietnam-medical-device-labeling-requirements 2026-10-15