https://www.pureglobal.com/de/glossary/anatel Brasilien ANATEL: Benötigt Ihr Produkt es? https://www.pureglobal.com/assets/video-posters/2kjDRrmC01o02EgPyoQIq01AWl3wjZamMzEKd00cpxiM8UY.jpg Erfahren Sie, wann ein vernetztes Medizinprodukt in Brasilien eine ANATEL-Funkhomologation benötigt und was das Verfahren umfasst. https://stream.mux.com/2kjDRrmC01o02EgPyoQIq01AWl3wjZamMzEKd00cpxiM8UY.m3u8 https://player.mux.com/2kjDRrmC01o02EgPyoQIq01AWl3wjZamMzEKd00cpxiM8UY?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F2kjDRrmC01o02EgPyoQIq01AWl3wjZamMzEKd00cpxiM8UY.jpg&accent-color=%232451c6 107 2026-10-16T04:57:36.091Z 2026-07-27 https://www.pureglobal.com/de/glossary/anmat 2026-07-24 https://www.pureglobal.com/de/glossary/anvisa ANVISA: Wichtiges für Medizinprodukte-Teams zu Brasilien https://www.pureglobal.com/assets/video-posters/9LUiHrqsf3101swh9xc00Xd01DYx1PMsqsd1qf02emGmFYI.jpg ANVISA ist die brasilianische Gesundheitsbehörde. https://stream.mux.com/9LUiHrqsf3101swh9xc00Xd01DYx1PMsqsd1qf02emGmFYI.m3u8 https://player.mux.com/9LUiHrqsf3101swh9xc00Xd01DYx1PMsqsd1qf02emGmFYI?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F9LUiHrqsf3101swh9xc00Xd01DYx1PMsqsd1qf02emGmFYI.jpg&accent-color=%232451c6 138 2026-09-11T19:46:35.405Z 2026-09-11 https://www.pureglobal.com/de/glossary/asean-csdt 2026-07-27 https://www.pureglobal.com/de/glossary/asean-medical-device-directive-amdd 2026-07-27 https://www.pureglobal.com/de/glossary/australia-tga 2026-07-24 https://www.pureglobal.com/de/glossary/bangladesh-dgda 2026-07-24 https://www.pureglobal.com/de/glossary/breakthrough-devices-program 2026-08-11 https://www.pureglobal.com/de/glossary/ce-marking 2026-08-11 https://www.pureglobal.com/de/glossary/certificate-of-free-sale 2026-07-27 https://www.pureglobal.com/de/glossary/china-nmpa 2026-07-24 https://www.pureglobal.com/de/glossary/clia-waiver 2026-08-11 https://www.pureglobal.com/de/glossary/cofepris COFEPRIS: Was Medizinprodukte-Teams für Mexiko prüfen sollten https://www.pureglobal.com/assets/video-posters/meDvpBSwWdiKdMdeuFnxOWACSqBUwFf5evmingAR1L4.jpg COFEPRIS ist Mexikos Bundesbehörde für gesundheitliche Risiken unter dem Gesundheitsministerium. https://stream.mux.com/meDvpBSwWdiKdMdeuFnxOWACSqBUwFf5evmingAR1L4.m3u8 https://player.mux.com/meDvpBSwWdiKdMdeuFnxOWACSqBUwFf5evmingAR1L4?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FmeDvpBSwWdiKdMdeuFnxOWACSqBUwFf5evmingAR1L4.jpg&accent-color=%232451c6 140 2026-09-11T19:52:40.760Z 2026-09-11 https://www.pureglobal.com/de/glossary/combination-product 2026-08-11 https://www.pureglobal.com/de/glossary/companion-diagnostics 2026-08-11 https://www.pureglobal.com/de/glossary/conformity-assessment 2026-07-27 https://www.pureglobal.com/de/glossary/corrective-and-preventive-action-capa 2026-08-11 https://www.pureglobal.com/de/glossary/costa-rica-ministry-of-health 2026-07-24 https://www.pureglobal.com/de/glossary/current-good-manufacturing-practice-cgmp 2026-08-11 https://www.pureglobal.com/de/glossary/de-novo-classification 2026-08-11 https://www.pureglobal.com/de/glossary/decree-3770-of-2004 2026-07-27 https://www.pureglobal.com/de/glossary/decree-4725-2005 Kolumbien – Dekret 4725: Produktanforderungen erfassen https://www.pureglobal.com/assets/video-posters/RhwjV3m01sYiVDNkGIwlSh4Qz4CIveI3JiP02chpQRUCE.jpg Das im Jahr zweitausendfünf erlassene Dekret regelt Medizinprodukte für die Anwendung am Menschen in Kolumbien. https://stream.mux.com/RhwjV3m01sYiVDNkGIwlSh4Qz4CIveI3JiP02chpQRUCE.m3u8 https://player.mux.com/RhwjV3m01sYiVDNkGIwlSh4Qz4CIveI3JiP02chpQRUCE?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FRhwjV3m01sYiVDNkGIwlSh4Qz4CIveI3JiP02chpQRUCE.jpg&accent-color=%232451c6 146 2026-09-11T19:56:48.515Z 2026-09-11 https://www.pureglobal.com/de/glossary/design-controls 2026-08-11 https://www.pureglobal.com/de/glossary/design-history-file-dhf 2026-08-11 https://www.pureglobal.com/de/glossary/egypt-eda 2026-07-24 https://www.pureglobal.com/de/glossary/electronic-instructions-for-use-eifu 2026-08-11 https://www.pureglobal.com/de/glossary/eu-declaration-of-conformity 2026-07-27 https://www.pureglobal.com/de/glossary/eu-mdcg MDCG: Leitfäden für EU-Medizinprodukte https://www.pureglobal.com/assets/video-posters/vFXhHIvNgSwdjUa7Pv00wjCvN514HND1ata2JxDqcm900.jpg Erfahren Sie, was die EU Medical Device Coordination Group tut und wie ihre Leitfäden die Umsetzung von MDR und IVDR unterstützen. https://stream.mux.com/vFXhHIvNgSwdjUa7Pv00wjCvN514HND1ata2JxDqcm900.m3u8 https://player.mux.com/vFXhHIvNgSwdjUa7Pv00wjCvN514HND1ata2JxDqcm900?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FvFXhHIvNgSwdjUa7Pv00wjCvN514HND1ata2JxDqcm900.jpg&accent-color=%232451c6 109 2026-10-16T04:58:05.790Z 2026-07-27 https://www.pureglobal.com/de/glossary/eu-mdr 2026-08-11 https://www.pureglobal.com/de/glossary/european-commission 2026-07-24 https://www.pureglobal.com/de/glossary/fda-21-cfr-part-11 2026-08-11 https://www.pureglobal.com/de/glossary/fda-510k-premarket-notification 2026-08-11 https://www.pureglobal.com/de/glossary/fda-form-483 2026-08-11 https://www.pureglobal.com/de/glossary/fda-product-code 2026-08-11 https://www.pureglobal.com/de/glossary/fda-recall-classes 2026-08-11 https://www.pureglobal.com/de/glossary/fda-warning-letter 2026-08-11 https://www.pureglobal.com/de/glossary/field-safety-corrective-action-fsca 2026-07-27 https://www.pureglobal.com/de/glossary/general-safety-and-performance-requirements-gspr 2026-07-27 https://www.pureglobal.com/de/glossary/gmdn 2026-07-27 https://www.pureglobal.com/de/glossary/gudid 2026-08-11 https://www.pureglobal.com/de/glossary/health-canada-hc Health Canada: MDEL und MDL erklärt https://www.pureglobal.com/assets/video-posters/Elr3pp02daZ3cHrUOfyy5s2nYlMc00xm9IywdsJB1pc8A.jpg Verstehen Sie MDEL und MDL, Kanadas Medizinproduktklassen und die in diesem Video behandelten Lizenzgebühren. https://stream.mux.com/Elr3pp02daZ3cHrUOfyy5s2nYlMc00xm9IywdsJB1pc8A.m3u8 https://player.mux.com/Elr3pp02daZ3cHrUOfyy5s2nYlMc00xm9IywdsJB1pc8A?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FElr3pp02daZ3cHrUOfyy5s2nYlMc00xm9IywdsJB1pc8A.jpg&accent-color=%232451c6 111 2026-10-16T04:57:20.641Z 2026-07-24 https://www.pureglobal.com/de/glossary/hong-kong-mdd 2026-07-24 https://www.pureglobal.com/de/glossary/iec-60601-1 2026-07-27 https://www.pureglobal.com/de/glossary/iec-60601-1-2 2026-08-11 https://www.pureglobal.com/de/glossary/iec-62304 2026-07-27 https://www.pureglobal.com/de/glossary/iec-62366-1 2026-07-27 https://www.pureglobal.com/de/glossary/iec-81001-5-1 2026-07-27 https://www.pureglobal.com/de/glossary/imda Vietnam IMDA: Produktklassen und Registrierung https://www.pureglobal.com/assets/video-posters/ZeTHNh2Kol01XXJq1OHedf7LxxsqvCMugJssLn2Q1Vr4.jpg Lernen Sie Vietnams IMDA kennen und entdecken Sie Medizinproduktklassen A–D, Registrierungswege und Gebühren. https://stream.mux.com/ZeTHNh2Kol01XXJq1OHedf7LxxsqvCMugJssLn2Q1Vr4.m3u8 https://player.mux.com/ZeTHNh2Kol01XXJq1OHedf7LxxsqvCMugJssLn2Q1Vr4?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FZeTHNh2Kol01XXJq1OHedf7LxxsqvCMugJssLn2Q1Vr4.jpg&accent-color=%232451c6 107 2026-10-16T04:57:54.771Z 2026-07-24 https://www.pureglobal.com/de/glossary/imdrf 2026-07-27 https://www.pureglobal.com/de/glossary/india-cdsco 2026-07-24 https://www.pureglobal.com/de/glossary/indonesia-moh 2026-07-27 https://www.pureglobal.com/de/glossary/inmetro 2026-07-27 https://www.pureglobal.com/de/glossary/investigational-device-exemption-ide FDA IDE: Befreiungen für Prüfprodukte https://www.pureglobal.com/assets/video-posters/6VHfOLqokbmjvm0157534U1CEumk4LhdnLXa00ZB87XJI.jpg Erfahren Sie, wie Investigational Device Exemptions für Produktstudien, Risikobestimmungen und die FDA-Zulassung gelten. https://stream.mux.com/6VHfOLqokbmjvm0157534U1CEumk4LhdnLXa00ZB87XJI.m3u8 https://player.mux.com/6VHfOLqokbmjvm0157534U1CEumk4LhdnLXa00ZB87XJI?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F6VHfOLqokbmjvm0157534U1CEumk4LhdnLXa00ZB87XJI.jpg&accent-color=%232451c6 107 2026-10-16T04:58:22.372Z 2026-08-11 https://www.pureglobal.com/de/glossary/invima INVIMA: Ihre Medizinprodukte-Roadmap für Kolumbien https://www.pureglobal.com/assets/video-posters/TaTVkzT00gZPweJRKLZrwuCg42MdJICChuGaOTxF01UHA.jpg INVIMA ist Kolumbiens nationale Regulierungsbehörde für Gesundheitsprodukte. https://stream.mux.com/TaTVkzT00gZPweJRKLZrwuCg42MdJICChuGaOTxF01UHA.m3u8 https://player.mux.com/TaTVkzT00gZPweJRKLZrwuCg42MdJICChuGaOTxF01UHA?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FTaTVkzT00gZPweJRKLZrwuCg42MdJICChuGaOTxF01UHA.jpg&accent-color=%232451c6 135 2026-09-11T19:44:36.008Z 2026-09-11 https://www.pureglobal.com/de/glossary/iso-10993 2026-07-27 https://www.pureglobal.com/de/glossary/iso-11135 2026-07-27 https://www.pureglobal.com/de/glossary/iso-11137 2026-07-27 https://www.pureglobal.com/de/glossary/iso-11607 2026-07-27 https://www.pureglobal.com/de/glossary/iso-13485 2026-07-27 https://www.pureglobal.com/de/glossary/iso-14155 2026-07-27 https://www.pureglobal.com/de/glossary/iso-14644 2026-08-11 https://www.pureglobal.com/de/glossary/iso-14971 2026-07-27 https://www.pureglobal.com/de/glossary/iso-15223-1 ISO 15223-1: Was Kennzeichnungen aussagen müssen https://www.pureglobal.com/assets/video-posters/gsWaTYCoYM1QMfHS01wNKIG7DxPSQu7jyXcsu5wPg02tc.jpg Die Norm legt Symbole für die mit Medizinprodukten bereitzustellenden Informationen fest. https://stream.mux.com/gsWaTYCoYM1QMfHS01wNKIG7DxPSQu7jyXcsu5wPg02tc.m3u8 https://player.mux.com/gsWaTYCoYM1QMfHS01wNKIG7DxPSQu7jyXcsu5wPg02tc?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FgsWaTYCoYM1QMfHS01wNKIG7DxPSQu7jyXcsu5wPg02tc.jpg&accent-color=%232451c6 142 2026-09-11T19:54:43.189Z 2026-09-11 https://www.pureglobal.com/de/glossary/iso-17665 2026-07-27 https://www.pureglobal.com/de/glossary/iso-20417 2026-07-27 https://www.pureglobal.com/de/glossary/israel-amar 2026-07-24 https://www.pureglobal.com/de/glossary/japan-mhlw Japan: MHLW und PMDA: Wer macht was? https://www.pureglobal.com/assets/video-posters/3gAeUlzNCF201K8KXsLXA73tTeBuaFWlwjrm6upjO02sg.jpg MHLW ist Japans Ministerium für Gesundheit, Arbeit und Soziales. https://stream.mux.com/3gAeUlzNCF201K8KXsLXA73tTeBuaFWlwjrm6upjO02sg.m3u8 https://player.mux.com/3gAeUlzNCF201K8KXsLXA73tTeBuaFWlwjrm6upjO02sg?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F3gAeUlzNCF201K8KXsLXA73tTeBuaFWlwjrm6upjO02sg.jpg&accent-color=%232451c6 151 2026-09-11T19:48:37.119Z 2026-09-11 https://www.pureglobal.com/de/glossary/japan-pmda Japan PMDA: Zulassungswege & Prüffristen https://www.pureglobal.com/assets/video-posters/dKRTxxT02r8v9kMX6ns5rG3dmEE9ap73mU5cX36R25Hw.jpg Ein Videoleitfaden zu Japans PMDA, Produktklassen, Meldung, Zertifizierung, Ministeriumszulassung und Prüffristen. https://stream.mux.com/dKRTxxT02r8v9kMX6ns5rG3dmEE9ap73mU5cX36R25Hw.m3u8 https://player.mux.com/dKRTxxT02r8v9kMX6ns5rG3dmEE9ap73mU5cX36R25Hw?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FdKRTxxT02r8v9kMX6ns5rG3dmEE9ap73mU5cX36R25Hw.jpg&accent-color=%232451c6 103 2026-10-16T04:56:46.728Z 2026-07-24 https://www.pureglobal.com/de/glossary/laboratory-developed-test-ldt 2026-08-11 https://www.pureglobal.com/de/glossary/macau-isaf 2026-07-24 https://www.pureglobal.com/de/glossary/malaysia-mda Malaysia MDA: Regulierung von Medizinprodukten https://www.pureglobal.com/assets/video-posters/11KfReMlINv12OFt8uFn4qlyx300rCqE02ukcSqql4XFI.jpg Ein Überblick über Malaysias Medical Device Authority, Produktregistrierung, lokale Vertretung und Gebühren für Klasse A. https://stream.mux.com/11KfReMlINv12OFt8uFn4qlyx300rCqE02ukcSqql4XFI.m3u8 https://player.mux.com/11KfReMlINv12OFt8uFn4qlyx300rCqE02ukcSqql4XFI?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F11KfReMlINv12OFt8uFn4qlyx300rCqE02ukcSqql4XFI.jpg&accent-color=%232451c6 110 2026-10-16T04:56:46.830Z 2026-07-24 https://www.pureglobal.com/de/glossary/maude-database 2026-08-11 https://www.pureglobal.com/de/glossary/mdall 2026-08-11 https://www.pureglobal.com/de/glossary/mdsap 2026-07-27 https://www.pureglobal.com/de/glossary/medical-device-classification 2026-07-27 https://www.pureglobal.com/de/glossary/medical-device-reporting-mdr 2026-08-11 https://www.pureglobal.com/de/glossary/medical-device-technical-file 2026-07-27 https://www.pureglobal.com/de/glossary/medsafe 2026-07-24 https://www.pureglobal.com/de/glossary/medwatch 2026-08-11 https://www.pureglobal.com/de/glossary/mexico-general-health-law Mexikos Allgemeines Gesundheitsgesetz, erklärt https://www.pureglobal.com/assets/video-posters/juRER2YvYRoh7UezJr00SztWaEGKMA1KTFbmib00WlgXs.jpg Praktische Einführung für Medizinprodukte-Teams: der Rechtsrahmen, die Rolle von COFEPRIS und drei Prüfpunkte vor der Planung einer Einreichung. https://stream.mux.com/juRER2YvYRoh7UezJr00SztWaEGKMA1KTFbmib00WlgXs.m3u8 https://player.mux.com/juRER2YvYRoh7UezJr00SztWaEGKMA1KTFbmib00WlgXs?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FjuRER2YvYRoh7UezJr00SztWaEGKMA1KTFbmib00WlgXs.jpg&accent-color=%232451c6 127 2026-09-11T05:25:47.919Z 2026-09-11 https://www.pureglobal.com/de/glossary/mhra MHRA: UK-Regeln für Medizinprodukte https://www.pureglobal.com/assets/video-posters/PiCcyO02oZcLiqy7n3tHnXD2lZRah9m01cMKWrB67HxIY.jpg Ein Leitfaden zu MHRA, der UK-Medizinprodukteregulierung und den im Video besprochenen CE- und UKCA-Kennzeichnungswegen. https://stream.mux.com/PiCcyO02oZcLiqy7n3tHnXD2lZRah9m01cMKWrB67HxIY.m3u8 https://player.mux.com/PiCcyO02oZcLiqy7n3tHnXD2lZRah9m01cMKWrB67HxIY?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FPiCcyO02oZcLiqy7n3tHnXD2lZRah9m01cMKWrB67HxIY.jpg&accent-color=%232451c6 107 2026-10-16T04:57:38.088Z 2026-07-24 https://www.pureglobal.com/de/glossary/notified-body 2026-08-11 https://www.pureglobal.com/de/glossary/pakistan-drap 2026-07-24 https://www.pureglobal.com/de/glossary/periodic-safety-update-report-psur 2026-07-27 https://www.pureglobal.com/de/glossary/peru-digemid 2026-07-24 https://www.pureglobal.com/de/glossary/philippines-fda 2026-07-24 https://www.pureglobal.com/de/glossary/post-market-surveillance-pms 2026-08-11 https://www.pureglobal.com/de/glossary/predicate-device 2026-08-11 https://www.pureglobal.com/de/glossary/premarket-approval-pma 2026-08-11 https://www.pureglobal.com/de/glossary/qmsr 2026-07-24 https://www.pureglobal.com/de/glossary/quality-management-system-qms 2026-08-11 https://www.pureglobal.com/de/glossary/rdc-751-2022 Brasilien RDC 751: Einstufung, Dossier und Kennzeichnung https://www.pureglobal.com/assets/video-posters/UXWzkzXjSBUzZZwjenE2smIzhnUwR3m7qTxGPrCv9xA.jpg Die Resolution trat im März zweitausenddreiundzwanzig in Kraft. https://stream.mux.com/UXWzkzXjSBUzZZwjenE2smIzhnUwR3m7qTxGPrCv9xA.m3u8 https://player.mux.com/UXWzkzXjSBUzZZwjenE2smIzhnUwR3m7qTxGPrCv9xA?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FUXWzkzXjSBUzZZwjenE2smIzhnUwR3m7qTxGPrCv9xA.jpg&accent-color=%232451c6 146 2026-09-11T20:03:12.313Z 2026-09-11 https://www.pureglobal.com/de/glossary/rdc-830-2023 2026-07-27 https://www.pureglobal.com/de/glossary/saudi-sfda Saudi-SFDA: Produktzulassung und lokale Rollen https://www.pureglobal.com/assets/video-posters/yl007jmwEoO4b9cU00ZSL3ENE8K6hvdoBd4XvbIBpQxCo.jpg Die Saudi Food and Drug Authority reguliert Medizinprodukte und In-vitro-Diagnostika. https://stream.mux.com/yl007jmwEoO4b9cU00ZSL3ENE8K6hvdoBd4XvbIBpQxCo.m3u8 https://player.mux.com/yl007jmwEoO4b9cU00ZSL3ENE8K6hvdoBd4XvbIBpQxCo?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2Fyl007jmwEoO4b9cU00ZSL3ENE8K6hvdoBd4XvbIBpQxCo.jpg&accent-color=%232451c6 140 2026-09-11T20:01:03.080Z 2026-09-11 https://www.pureglobal.com/de/glossary/singapore-hsa Singapur HSA: Den Zulassungsweg wählen https://www.pureglobal.com/assets/video-posters/8eG4qcrJLOV00oW3uAKwdreXY029RG5JjNCB01n6SwE3Qc.jpg HSA ist die Health Sciences Authority von Singapur. https://stream.mux.com/8eG4qcrJLOV00oW3uAKwdreXY029RG5JjNCB01n6SwE3Qc.m3u8 https://player.mux.com/8eG4qcrJLOV00oW3uAKwdreXY029RG5JjNCB01n6SwE3Qc?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F8eG4qcrJLOV00oW3uAKwdreXY029RG5JjNCB01n6SwE3Qc.jpg&accent-color=%232451c6 146 2026-09-11T19:59:03.589Z 2026-09-11 https://www.pureglobal.com/de/glossary/south-korea-mfds 2026-07-24 https://www.pureglobal.com/de/glossary/swissmedic 2026-07-24 https://www.pureglobal.com/de/glossary/taiwan-tfda 2026-07-24 https://www.pureglobal.com/de/glossary/thailand-fda Thai FDA: Praktische Checkliste zur Markteinführung https://www.pureglobal.com/assets/video-posters/43cFWQXgdZ3hIddRQ500Spg7KaoyBpR02JN3pXs00QRUyo.jpg Die thailändische FDA reguliert Gesundheitsprodukte unter dem Ministerium für öffentliche Gesundheit. https://stream.mux.com/43cFWQXgdZ3hIddRQ500Spg7KaoyBpR02JN3pXs00QRUyo.m3u8 https://player.mux.com/43cFWQXgdZ3hIddRQ500Spg7KaoyBpR02JN3pXs00QRUyo?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F43cFWQXgdZ3hIddRQ500Spg7KaoyBpR02JN3pXs00QRUyo.jpg&accent-color=%232451c6 135 2026-09-11T19:50:38.679Z 2026-09-11 https://www.pureglobal.com/de/glossary/uae-ede 2026-07-24 https://www.pureglobal.com/de/glossary/ukca-marking 2026-08-11 https://www.pureglobal.com/de/glossary/unique-device-identification-udi 2026-07-27 https://www.pureglobal.com/de/glossary/us-fda US-FDA: Medizinprodukteregulierung https://www.pureglobal.com/assets/video-posters/J7lElt7fst3xxIh2KjnM81YMqzOVealMu7YBI5ypv1c.jpg Eine Einführung in FDA und CDRH, Risikoklassen von Medizinprodukten, Einreichungswege und Nutzergebühren. https://stream.mux.com/J7lElt7fst3xxIh2KjnM81YMqzOVealMu7YBI5ypv1c.m3u8 https://player.mux.com/J7lElt7fst3xxIh2KjnM81YMqzOVealMu7YBI5ypv1c?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FJ7lElt7fst3xxIh2KjnM81YMqzOVealMu7YBI5ypv1c.jpg&accent-color=%232451c6 118 2026-10-16T04:57:21.163Z 2026-07-24 https://www.pureglobal.com/de/glossary/vietnam-moh 2026-07-24 https://www.pureglobal.com/de/glossary/what-is-eudamed 2026-07-24 https://www.pureglobal.com/de/glossary/what-is-swissdamed 2026-10-15 https://www.pureglobal.com/de/glossary/what-is-the-artg Australien ARTG: Sponsoren, TGA-Gebühren https://www.pureglobal.com/assets/video-posters/ctdHI00Tr9g6pU1RmSJtpiyysaG7vvsZeEA02y01TOsHhg.jpg Erfahren Sie, was Australiens ARTG abdeckt und wie Produktsponsoren, Registrierung und TGA-Gebühren zusammenhängen. https://stream.mux.com/ctdHI00Tr9g6pU1RmSJtpiyysaG7vvsZeEA02y01TOsHhg.m3u8 https://player.mux.com/ctdHI00Tr9g6pU1RmSJtpiyysaG7vvsZeEA02y01TOsHhg?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FctdHI00Tr9g6pU1RmSJtpiyysaG7vvsZeEA02y01TOsHhg.jpg&accent-color=%232451c6 115 2026-10-16T04:57:03.866Z 2026-07-24 https://www.pureglobal.com/de/glossary/what-is-the-therapeutic-goods-act-1989-australia 2026-07-27 https://www.pureglobal.com/es/glossary/anatel Brasil: ¿su dispositivo requiere ANATEL? https://www.pureglobal.com/assets/video-posters/2kjDRrmC01o02EgPyoQIq01AWl3wjZamMzEKd00cpxiM8UY.jpg Sepa cuándo un dispositivo médico conectado necesita homologación de radio ANATEL en Brasil y qué implica el proceso. https://stream.mux.com/2kjDRrmC01o02EgPyoQIq01AWl3wjZamMzEKd00cpxiM8UY.m3u8 https://player.mux.com/2kjDRrmC01o02EgPyoQIq01AWl3wjZamMzEKd00cpxiM8UY?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F2kjDRrmC01o02EgPyoQIq01AWl3wjZamMzEKd00cpxiM8UY.jpg&accent-color=%232451c6 107 2026-10-16T04:57:36.091Z 2026-07-27 https://www.pureglobal.com/es/glossary/anmat 2026-07-24 https://www.pureglobal.com/es/glossary/anvisa ANVISA: Lo esencial para equipos de dispositivos en Brasil https://www.pureglobal.com/assets/video-posters/6Zt01d7iZ400KQDY1BFxGU3Uto41DO2vaQv1ratQhknCQ.jpg ANVISA es la agencia reguladora sanitaria de Brasil. https://stream.mux.com/6Zt01d7iZ400KQDY1BFxGU3Uto41DO2vaQv1ratQhknCQ.m3u8 https://player.mux.com/6Zt01d7iZ400KQDY1BFxGU3Uto41DO2vaQv1ratQhknCQ?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F6Zt01d7iZ400KQDY1BFxGU3Uto41DO2vaQv1ratQhknCQ.jpg&accent-color=%232451c6 129 2026-09-11T19:47:16.590Z 2026-09-11 https://www.pureglobal.com/es/glossary/asean-csdt 2026-07-27 https://www.pureglobal.com/es/glossary/asean-medical-device-directive-amdd 2026-07-27 https://www.pureglobal.com/es/glossary/australia-tga 2026-07-24 https://www.pureglobal.com/es/glossary/bangladesh-dgda 2026-07-24 https://www.pureglobal.com/es/glossary/breakthrough-devices-program 2026-08-11 https://www.pureglobal.com/es/glossary/ce-marking 2026-08-11 https://www.pureglobal.com/es/glossary/certificate-of-free-sale 2026-07-27 https://www.pureglobal.com/es/glossary/china-nmpa 2026-07-24 https://www.pureglobal.com/es/glossary/clia-waiver 2026-08-11 https://www.pureglobal.com/es/glossary/cofepris COFEPRIS: Qué deben verificar los equipos en México https://www.pureglobal.com/assets/video-posters/0101bxCPxBmEJ4DMi014VhY4ZAgKQ9Mn3KnCpDCKSGsyMI.jpg COFEPRIS es el regulador federal de riesgos sanitarios de México, dependiente de la Secretaría de Salud. https://stream.mux.com/0101bxCPxBmEJ4DMi014VhY4ZAgKQ9Mn3KnCpDCKSGsyMI.m3u8 https://player.mux.com/0101bxCPxBmEJ4DMi014VhY4ZAgKQ9Mn3KnCpDCKSGsyMI?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F0101bxCPxBmEJ4DMi014VhY4ZAgKQ9Mn3KnCpDCKSGsyMI.jpg&accent-color=%232451c6 134 2026-09-11T19:53:21.964Z 2026-09-11 https://www.pureglobal.com/es/glossary/combination-product 2026-08-11 https://www.pureglobal.com/es/glossary/companion-diagnostics 2026-08-11 https://www.pureglobal.com/es/glossary/conformity-assessment 2026-07-27 https://www.pureglobal.com/es/glossary/corrective-and-preventive-action-capa 2026-08-11 https://www.pureglobal.com/es/glossary/costa-rica-ministry-of-health 2026-07-24 https://www.pureglobal.com/es/glossary/current-good-manufacturing-practice-cgmp 2026-08-11 https://www.pureglobal.com/es/glossary/de-novo-classification 2026-08-11 https://www.pureglobal.com/es/glossary/decree-3770-of-2004 2026-07-27 https://www.pureglobal.com/es/glossary/decree-4725-2005 Decreto 4725 de Colombia: requisitos de dispositivos https://www.pureglobal.com/assets/video-posters/oTN0012q02H7c4uRnzcq9xbVSFZk7sCQTfbAg01JTu9Ou00.jpg Expedido en dos mil cinco, el decreto regula los dispositivos médicos para uso humano en Colombia. https://stream.mux.com/oTN0012q02H7c4uRnzcq9xbVSFZk7sCQTfbAg01JTu9Ou00.m3u8 https://player.mux.com/oTN0012q02H7c4uRnzcq9xbVSFZk7sCQTfbAg01JTu9Ou00?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FoTN0012q02H7c4uRnzcq9xbVSFZk7sCQTfbAg01JTu9Ou00.jpg&accent-color=%232451c6 140 2026-09-11T19:57:32.686Z 2026-09-11 https://www.pureglobal.com/es/glossary/design-controls 2026-08-11 https://www.pureglobal.com/es/glossary/design-history-file-dhf 2026-08-11 https://www.pureglobal.com/es/glossary/egypt-eda 2026-07-24 https://www.pureglobal.com/es/glossary/electronic-instructions-for-use-eifu 2026-08-11 https://www.pureglobal.com/es/glossary/eu-declaration-of-conformity 2026-07-27 https://www.pureglobal.com/es/glossary/eu-mdcg MDCG: guías de dispositivos médicos de la UE https://www.pureglobal.com/assets/video-posters/vFXhHIvNgSwdjUa7Pv00wjCvN514HND1ata2JxDqcm900.jpg Conozca qué hace el Grupo de Coordinación de Dispositivos Médicos de la UE y cómo sus guías apoyan la aplicación del MDR y del IVDR. https://stream.mux.com/vFXhHIvNgSwdjUa7Pv00wjCvN514HND1ata2JxDqcm900.m3u8 https://player.mux.com/vFXhHIvNgSwdjUa7Pv00wjCvN514HND1ata2JxDqcm900?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FvFXhHIvNgSwdjUa7Pv00wjCvN514HND1ata2JxDqcm900.jpg&accent-color=%232451c6 109 2026-10-16T04:58:05.790Z 2026-07-27 https://www.pureglobal.com/es/glossary/eu-mdr 2026-08-11 https://www.pureglobal.com/es/glossary/european-commission 2026-07-24 https://www.pureglobal.com/es/glossary/fda-21-cfr-part-11 2026-08-11 https://www.pureglobal.com/es/glossary/fda-510k-premarket-notification 2026-08-11 https://www.pureglobal.com/es/glossary/fda-form-483 2026-08-11 https://www.pureglobal.com/es/glossary/fda-product-code 2026-08-11 https://www.pureglobal.com/es/glossary/fda-recall-classes 2026-08-11 https://www.pureglobal.com/es/glossary/fda-warning-letter 2026-08-11 https://www.pureglobal.com/es/glossary/field-safety-corrective-action-fsca 2026-07-27 https://www.pureglobal.com/es/glossary/general-safety-and-performance-requirements-gspr 2026-07-27 https://www.pureglobal.com/es/glossary/gmdn 2026-07-27 https://www.pureglobal.com/es/glossary/gudid 2026-08-11 https://www.pureglobal.com/es/glossary/health-canada-hc Health Canada: explicación de MDEL y MDL https://www.pureglobal.com/assets/video-posters/Elr3pp02daZ3cHrUOfyy5s2nYlMc00xm9IywdsJB1pc8A.jpg Comprenda la MDEL y la MDL, las clases de dispositivos médicos de Canadá y las tarifas de licencias tratadas en este video. https://stream.mux.com/Elr3pp02daZ3cHrUOfyy5s2nYlMc00xm9IywdsJB1pc8A.m3u8 https://player.mux.com/Elr3pp02daZ3cHrUOfyy5s2nYlMc00xm9IywdsJB1pc8A?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FElr3pp02daZ3cHrUOfyy5s2nYlMc00xm9IywdsJB1pc8A.jpg&accent-color=%232451c6 111 2026-10-16T04:57:20.641Z 2026-07-24 https://www.pureglobal.com/es/glossary/hong-kong-mdd 2026-07-24 https://www.pureglobal.com/es/glossary/iec-60601-1 2026-07-27 https://www.pureglobal.com/es/glossary/iec-60601-1-2 2026-08-11 https://www.pureglobal.com/es/glossary/iec-62304 2026-07-27 https://www.pureglobal.com/es/glossary/iec-62366-1 2026-07-27 https://www.pureglobal.com/es/glossary/iec-81001-5-1 2026-07-27 https://www.pureglobal.com/es/glossary/imda IMDA de Vietnam: clases de dispositivos y registro https://www.pureglobal.com/assets/video-posters/ZeTHNh2Kol01XXJq1OHedf7LxxsqvCMugJssLn2Q1Vr4.jpg Conozca la IMDA de Vietnam y explore las clases de dispositivos médicos A–D, las vías de registro y las tarifas. https://stream.mux.com/ZeTHNh2Kol01XXJq1OHedf7LxxsqvCMugJssLn2Q1Vr4.m3u8 https://player.mux.com/ZeTHNh2Kol01XXJq1OHedf7LxxsqvCMugJssLn2Q1Vr4?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FZeTHNh2Kol01XXJq1OHedf7LxxsqvCMugJssLn2Q1Vr4.jpg&accent-color=%232451c6 107 2026-10-16T04:57:54.771Z 2026-07-24 https://www.pureglobal.com/es/glossary/imdrf 2026-07-27 https://www.pureglobal.com/es/glossary/india-cdsco 2026-07-24 https://www.pureglobal.com/es/glossary/indonesia-moh 2026-07-27 https://www.pureglobal.com/es/glossary/inmetro 2026-07-27 https://www.pureglobal.com/es/glossary/investigational-device-exemption-ide FDA IDE: exenciones de investigación https://www.pureglobal.com/assets/video-posters/6VHfOLqokbmjvm0157534U1CEumk4LhdnLXa00ZB87XJI.jpg Conozca cómo aplican las exenciones de dispositivos de investigación a estudios clínicos, determinación de riesgos y aprobación de FDA. https://stream.mux.com/6VHfOLqokbmjvm0157534U1CEumk4LhdnLXa00ZB87XJI.m3u8 https://player.mux.com/6VHfOLqokbmjvm0157534U1CEumk4LhdnLXa00ZB87XJI?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F6VHfOLqokbmjvm0157534U1CEumk4LhdnLXa00ZB87XJI.jpg&accent-color=%232451c6 107 2026-10-16T04:58:22.372Z 2026-08-11 https://www.pureglobal.com/es/glossary/invima INVIMA: su hoja de ruta de dispositivos en Colombia https://www.pureglobal.com/assets/video-posters/S10002AiwgfUmgWa1aPJCVxrpaTS4XGV9z2IqzewbpQA4.jpg INVIMA es la autoridad sanitaria nacional de productos para la salud en Colombia. https://stream.mux.com/S10002AiwgfUmgWa1aPJCVxrpaTS4XGV9z2IqzewbpQA4.m3u8 https://player.mux.com/S10002AiwgfUmgWa1aPJCVxrpaTS4XGV9z2IqzewbpQA4?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FS10002AiwgfUmgWa1aPJCVxrpaTS4XGV9z2IqzewbpQA4.jpg&accent-color=%232451c6 131 2026-09-11T19:45:15.246Z 2026-09-11 https://www.pureglobal.com/es/glossary/iso-10993 2026-07-27 https://www.pureglobal.com/es/glossary/iso-11135 2026-07-27 https://www.pureglobal.com/es/glossary/iso-11137 2026-07-27 https://www.pureglobal.com/es/glossary/iso-11607 2026-07-27 https://www.pureglobal.com/es/glossary/iso-13485 2026-07-27 https://www.pureglobal.com/es/glossary/iso-14155 2026-07-27 https://www.pureglobal.com/es/glossary/iso-14644 2026-08-11 https://www.pureglobal.com/es/glossary/iso-14971 2026-07-27 https://www.pureglobal.com/es/glossary/iso-15223-1 ISO 15223-1: Qué deben indicar las etiquetas https://www.pureglobal.com/assets/video-posters/gw1ty3rtEI2EvwE1hiCq1cwYblvjz7tLDjAjU4lkhzQ.jpg La norma especifica símbolos para la información suministrada con los dispositivos médicos. https://stream.mux.com/gw1ty3rtEI2EvwE1hiCq1cwYblvjz7tLDjAjU4lkhzQ.m3u8 https://player.mux.com/gw1ty3rtEI2EvwE1hiCq1cwYblvjz7tLDjAjU4lkhzQ?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2Fgw1ty3rtEI2EvwE1hiCq1cwYblvjz7tLDjAjU4lkhzQ.jpg&accent-color=%232451c6 133 2026-09-11T19:55:24.734Z 2026-09-11 https://www.pureglobal.com/es/glossary/iso-17665 2026-07-27 https://www.pureglobal.com/es/glossary/iso-20417 2026-07-27 https://www.pureglobal.com/es/glossary/israel-amar 2026-07-24 https://www.pureglobal.com/es/glossary/japan-mhlw MHLW y PMDA en Japón: ¿quién hace qué? https://www.pureglobal.com/assets/video-posters/pSNZ00suAIbZ9jZyNQ016Xw2oLBfI3CwPuxO9Qyyyztm00.jpg eme hache ele doble u es el Ministerio de Salud, Trabajo y Bienestar de Japón. https://stream.mux.com/pSNZ00suAIbZ9jZyNQ016Xw2oLBfI3CwPuxO9Qyyyztm00.m3u8 https://player.mux.com/pSNZ00suAIbZ9jZyNQ016Xw2oLBfI3CwPuxO9Qyyyztm00?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FpSNZ00suAIbZ9jZyNQ016Xw2oLBfI3CwPuxO9Qyyyztm00.jpg&accent-color=%232451c6 148 2026-09-11T19:49:19.044Z 2026-09-11 https://www.pureglobal.com/es/glossary/japan-pmda Japón PMDA: vías y plazos de revisión https://www.pureglobal.com/assets/video-posters/dKRTxxT02r8v9kMX6ns5rG3dmEE9ap73mU5cX36R25Hw.jpg Guía en video sobre PMDA en Japón, clases de dispositivos, notificación, certificación, aprobación ministerial y plazos de revisión. https://stream.mux.com/dKRTxxT02r8v9kMX6ns5rG3dmEE9ap73mU5cX36R25Hw.m3u8 https://player.mux.com/dKRTxxT02r8v9kMX6ns5rG3dmEE9ap73mU5cX36R25Hw?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FdKRTxxT02r8v9kMX6ns5rG3dmEE9ap73mU5cX36R25Hw.jpg&accent-color=%232451c6 103 2026-10-16T04:56:46.728Z 2026-07-24 https://www.pureglobal.com/es/glossary/laboratory-developed-test-ldt 2026-08-11 https://www.pureglobal.com/es/glossary/macau-isaf 2026-07-24 https://www.pureglobal.com/es/glossary/malaysia-mda MDA de Malasia: regulación de dispositivos médicos https://www.pureglobal.com/assets/video-posters/11KfReMlINv12OFt8uFn4qlyx300rCqE02ukcSqql4XFI.jpg Panorama de la Autoridad de Dispositivos Médicos de Malasia, registro de dispositivos, representación local y tarifas de Clase A. https://stream.mux.com/11KfReMlINv12OFt8uFn4qlyx300rCqE02ukcSqql4XFI.m3u8 https://player.mux.com/11KfReMlINv12OFt8uFn4qlyx300rCqE02ukcSqql4XFI?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F11KfReMlINv12OFt8uFn4qlyx300rCqE02ukcSqql4XFI.jpg&accent-color=%232451c6 110 2026-10-16T04:56:46.830Z 2026-07-24 https://www.pureglobal.com/es/glossary/maude-database 2026-08-11 https://www.pureglobal.com/es/glossary/mdall 2026-08-11 https://www.pureglobal.com/es/glossary/mdsap 2026-07-27 https://www.pureglobal.com/es/glossary/medical-device-classification 2026-07-27 https://www.pureglobal.com/es/glossary/medical-device-reporting-mdr 2026-08-11 https://www.pureglobal.com/es/glossary/medical-device-technical-file 2026-07-27 https://www.pureglobal.com/es/glossary/medsafe 2026-07-24 https://www.pureglobal.com/es/glossary/medwatch 2026-08-11 https://www.pureglobal.com/es/glossary/mexico-general-health-law La Ley General de Salud de México, explicada https://www.pureglobal.com/assets/video-posters/Slva6uB6lemVTWiE00LzwJos1jEsQHKuhvRExmFpU9dI.jpg Una introducción práctica para equipos de dispositivos médicos: marco legal, rol de COFEPRIS y tres verificaciones antes de planificar una solicitud. https://stream.mux.com/Slva6uB6lemVTWiE00LzwJos1jEsQHKuhvRExmFpU9dI.m3u8 https://player.mux.com/Slva6uB6lemVTWiE00LzwJos1jEsQHKuhvRExmFpU9dI?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FSlva6uB6lemVTWiE00LzwJos1jEsQHKuhvRExmFpU9dI.jpg&accent-color=%232451c6 121 2026-09-11T05:27:06.999Z 2026-09-11 https://www.pureglobal.com/es/glossary/mhra MHRA: normas británicas de dispositivos https://www.pureglobal.com/assets/video-posters/PiCcyO02oZcLiqy7n3tHnXD2lZRah9m01cMKWrB67HxIY.jpg Guía sobre la MHRA, la regulación de dispositivos del Reino Unido y las vías de marcado CE y UKCA tratadas en este video. https://stream.mux.com/PiCcyO02oZcLiqy7n3tHnXD2lZRah9m01cMKWrB67HxIY.m3u8 https://player.mux.com/PiCcyO02oZcLiqy7n3tHnXD2lZRah9m01cMKWrB67HxIY?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FPiCcyO02oZcLiqy7n3tHnXD2lZRah9m01cMKWrB67HxIY.jpg&accent-color=%232451c6 107 2026-10-16T04:57:38.088Z 2026-07-24 https://www.pureglobal.com/es/glossary/notified-body 2026-08-11 https://www.pureglobal.com/es/glossary/pakistan-drap 2026-07-24 https://www.pureglobal.com/es/glossary/periodic-safety-update-report-psur 2026-07-27 https://www.pureglobal.com/es/glossary/peru-digemid 2026-07-24 https://www.pureglobal.com/es/glossary/philippines-fda 2026-07-24 https://www.pureglobal.com/es/glossary/post-market-surveillance-pms 2026-08-11 https://www.pureglobal.com/es/glossary/predicate-device 2026-08-11 https://www.pureglobal.com/es/glossary/premarket-approval-pma 2026-08-11 https://www.pureglobal.com/es/glossary/qmsr 2026-07-24 https://www.pureglobal.com/es/glossary/quality-management-system-qms 2026-08-11 https://www.pureglobal.com/es/glossary/rdc-751-2022 Brasil RDC 751: clasificación, dosier y etiquetado https://www.pureglobal.com/assets/video-posters/GMgoSuaIdgu8GkhLGR02d02T2yNXAYuavEWHQfgkXOJYU.jpg La resolución entró en vigor en marzo de dos mil veintitrés. https://stream.mux.com/GMgoSuaIdgu8GkhLGR02d02T2yNXAYuavEWHQfgkXOJYU.m3u8 https://player.mux.com/GMgoSuaIdgu8GkhLGR02d02T2yNXAYuavEWHQfgkXOJYU?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FGMgoSuaIdgu8GkhLGR02d02T2yNXAYuavEWHQfgkXOJYU.jpg&accent-color=%232451c6 142 2026-09-11T20:03:58.271Z 2026-09-11 https://www.pureglobal.com/es/glossary/rdc-830-2023 2026-07-27 https://www.pureglobal.com/es/glossary/saudi-sfda SFDA de Arabia Saudita: autorización de dispositivos y roles locales https://www.pureglobal.com/assets/video-posters/A02fPtWUzR2IUEX69FrwFUxQdY9gEP81cz1pVdjBGNAY.jpg La Saudi Food and Drug Authority regula los dispositivos médicos y los productos de diagnóstico in vitro. https://stream.mux.com/A02fPtWUzR2IUEX69FrwFUxQdY9gEP81cz1pVdjBGNAY.m3u8 https://player.mux.com/A02fPtWUzR2IUEX69FrwFUxQdY9gEP81cz1pVdjBGNAY?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FA02fPtWUzR2IUEX69FrwFUxQdY9gEP81cz1pVdjBGNAY.jpg&accent-color=%232451c6 142 2026-09-11T20:01:46.743Z 2026-09-11 https://www.pureglobal.com/es/glossary/singapore-hsa Singapur HSA: cómo elegir la vía del dispositivo https://www.pureglobal.com/assets/video-posters/i7SECjgxMeQ1M61vhR9ZzjYVVVAWT2RQwkxNVi2Wgew.jpg HSA es la Health Sciences Authority de Singapur. https://stream.mux.com/i7SECjgxMeQ1M61vhR9ZzjYVVVAWT2RQwkxNVi2Wgew.m3u8 https://player.mux.com/i7SECjgxMeQ1M61vhR9ZzjYVVVAWT2RQwkxNVi2Wgew?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2Fi7SECjgxMeQ1M61vhR9ZzjYVVVAWT2RQwkxNVi2Wgew.jpg&accent-color=%232451c6 142 2026-09-11T19:59:43.754Z 2026-09-11 https://www.pureglobal.com/es/glossary/south-korea-mfds 2026-07-24 https://www.pureglobal.com/es/glossary/swissmedic 2026-07-24 https://www.pureglobal.com/es/glossary/taiwan-tfda 2026-07-24 https://www.pureglobal.com/es/glossary/thailand-fda FDA en Tailandia: lista práctica de lanzamiento https://www.pureglobal.com/assets/video-posters/Po01H5Go801SpqNx726J02ELROFxEiKRUE5PgPo8enYFdQ.jpg La FDA de Tailandia regula los productos para la salud bajo el Ministerio de Salud Pública. https://stream.mux.com/Po01H5Go801SpqNx726J02ELROFxEiKRUE5PgPo8enYFdQ.m3u8 https://player.mux.com/Po01H5Go801SpqNx726J02ELROFxEiKRUE5PgPo8enYFdQ?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FPo01H5Go801SpqNx726J02ELROFxEiKRUE5PgPo8enYFdQ.jpg&accent-color=%232451c6 137 2026-09-11T19:51:22.939Z 2026-09-11 https://www.pureglobal.com/es/glossary/uae-ede 2026-07-24 https://www.pureglobal.com/es/glossary/ukca-marking 2026-08-11 https://www.pureglobal.com/es/glossary/unique-device-identification-udi 2026-07-27 https://www.pureglobal.com/es/glossary/us-fda EE. UU. FDA: regulación de dispositivos https://www.pureglobal.com/assets/video-posters/J7lElt7fst3xxIh2KjnM81YMqzOVealMu7YBI5ypv1c.jpg Una introducción a FDA y CDRH, clases de riesgo de dispositivos médicos, vías de presentación y tarifas de usuario. https://stream.mux.com/J7lElt7fst3xxIh2KjnM81YMqzOVealMu7YBI5ypv1c.m3u8 https://player.mux.com/J7lElt7fst3xxIh2KjnM81YMqzOVealMu7YBI5ypv1c?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FJ7lElt7fst3xxIh2KjnM81YMqzOVealMu7YBI5ypv1c.jpg&accent-color=%232451c6 118 2026-10-16T04:57:21.163Z 2026-07-24 https://www.pureglobal.com/es/glossary/vietnam-moh 2026-07-24 https://www.pureglobal.com/es/glossary/what-is-eudamed 2026-07-24 https://www.pureglobal.com/es/glossary/what-is-swissdamed 2026-10-15 https://www.pureglobal.com/es/glossary/what-is-the-artg Australia ARTG: sponsors y tarifas TGA https://www.pureglobal.com/assets/video-posters/ctdHI00Tr9g6pU1RmSJtpiyysaG7vvsZeEA02y01TOsHhg.jpg Conozca qué cubre el ARTG de Australia y cómo se articulan los patrocinadores, el registro de dispositivos y las tarifas TGA. https://stream.mux.com/ctdHI00Tr9g6pU1RmSJtpiyysaG7vvsZeEA02y01TOsHhg.m3u8 https://player.mux.com/ctdHI00Tr9g6pU1RmSJtpiyysaG7vvsZeEA02y01TOsHhg?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FctdHI00Tr9g6pU1RmSJtpiyysaG7vvsZeEA02y01TOsHhg.jpg&accent-color=%232451c6 115 2026-10-16T04:57:03.866Z 2026-07-24 https://www.pureglobal.com/es/glossary/what-is-the-therapeutic-goods-act-1989-australia 2026-07-27 https://www.pureglobal.com/fr/glossary/anatel Brésil ANATEL : votre DM est-il concerné ? https://www.pureglobal.com/assets/video-posters/2kjDRrmC01o02EgPyoQIq01AWl3wjZamMzEKd00cpxiM8UY.jpg Découvrez quand un dispositif médical connecté requiert l'homologation radio ANATEL au Brésil et les étapes du processus. https://stream.mux.com/2kjDRrmC01o02EgPyoQIq01AWl3wjZamMzEKd00cpxiM8UY.m3u8 https://player.mux.com/2kjDRrmC01o02EgPyoQIq01AWl3wjZamMzEKd00cpxiM8UY?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F2kjDRrmC01o02EgPyoQIq01AWl3wjZamMzEKd00cpxiM8UY.jpg&accent-color=%232451c6 107 2026-10-16T04:57:36.091Z 2026-07-27 https://www.pureglobal.com/fr/glossary/anmat 2026-07-24 https://www.pureglobal.com/fr/glossary/anvisa ANVISA : ce que doivent savoir les équipes dispositifs https://www.pureglobal.com/assets/video-posters/8QTyFwBcapGJo43rBprh15d4bGVZP3rlaY91hI00yY1U.jpg ANVISA est l'agence de réglementation sanitaire du Brésil. https://stream.mux.com/8QTyFwBcapGJo43rBprh15d4bGVZP3rlaY91hI00yY1U.m3u8 https://player.mux.com/8QTyFwBcapGJo43rBprh15d4bGVZP3rlaY91hI00yY1U?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F8QTyFwBcapGJo43rBprh15d4bGVZP3rlaY91hI00yY1U.jpg&accent-color=%232451c6 133 2026-09-11T19:47:41.913Z 2026-09-11 https://www.pureglobal.com/fr/glossary/asean-csdt 2026-07-27 https://www.pureglobal.com/fr/glossary/asean-medical-device-directive-amdd 2026-07-27 https://www.pureglobal.com/fr/glossary/australia-tga 2026-07-24 https://www.pureglobal.com/fr/glossary/bangladesh-dgda 2026-07-24 https://www.pureglobal.com/fr/glossary/breakthrough-devices-program 2026-08-11 https://www.pureglobal.com/fr/glossary/ce-marking 2026-08-11 https://www.pureglobal.com/fr/glossary/certificate-of-free-sale 2026-07-27 https://www.pureglobal.com/fr/glossary/china-nmpa 2026-07-24 https://www.pureglobal.com/fr/glossary/clia-waiver 2026-08-11 https://www.pureglobal.com/fr/glossary/cofepris COFEPRIS : ce qu'il faut vérifier au Mexique https://www.pureglobal.com/assets/video-posters/PNKw018xJI6xgi3hFN6W2pwDSbBwnca6ABw59hH8Tpfk.jpg COFEPRIS est l'autorité fédérale mexicaine chargée de la protection contre les risques sanitaires, rattachée au ministère de la Santé. https://stream.mux.com/PNKw018xJI6xgi3hFN6W2pwDSbBwnca6ABw59hH8Tpfk.m3u8 https://player.mux.com/PNKw018xJI6xgi3hFN6W2pwDSbBwnca6ABw59hH8Tpfk?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FPNKw018xJI6xgi3hFN6W2pwDSbBwnca6ABw59hH8Tpfk.jpg&accent-color=%232451c6 139 2026-09-11T19:53:47.555Z 2026-09-11 https://www.pureglobal.com/fr/glossary/combination-product 2026-08-11 https://www.pureglobal.com/fr/glossary/companion-diagnostics 2026-08-11 https://www.pureglobal.com/fr/glossary/conformity-assessment 2026-07-27 https://www.pureglobal.com/fr/glossary/corrective-and-preventive-action-capa 2026-08-11 https://www.pureglobal.com/fr/glossary/costa-rica-ministry-of-health 2026-07-24 https://www.pureglobal.com/fr/glossary/current-good-manufacturing-practice-cgmp 2026-08-11 https://www.pureglobal.com/fr/glossary/de-novo-classification 2026-08-11 https://www.pureglobal.com/fr/glossary/decree-3770-of-2004 2026-07-27 https://www.pureglobal.com/fr/glossary/decree-4725-2005 Décret colombien 4725 : cartographier les exigences https://www.pureglobal.com/assets/video-posters/WiIUc5oIwErJR3nYxksGcFuIYKGO7DPtI8T4HMdAj7o.jpg Promulgué en deux mille cinq, le décret régit les dispositifs médicaux à usage humain en Colombie. https://stream.mux.com/WiIUc5oIwErJR3nYxksGcFuIYKGO7DPtI8T4HMdAj7o.m3u8 https://player.mux.com/WiIUc5oIwErJR3nYxksGcFuIYKGO7DPtI8T4HMdAj7o?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FWiIUc5oIwErJR3nYxksGcFuIYKGO7DPtI8T4HMdAj7o.jpg&accent-color=%232451c6 139 2026-09-11T19:58:03.489Z 2026-09-11 https://www.pureglobal.com/fr/glossary/design-controls 2026-08-11 https://www.pureglobal.com/fr/glossary/design-history-file-dhf 2026-08-11 https://www.pureglobal.com/fr/glossary/egypt-eda 2026-07-24 https://www.pureglobal.com/fr/glossary/electronic-instructions-for-use-eifu 2026-08-11 https://www.pureglobal.com/fr/glossary/eu-declaration-of-conformity 2026-07-27 https://www.pureglobal.com/fr/glossary/eu-mdcg MDCG : guides de l'UE sur les dispositifs médicaux https://www.pureglobal.com/assets/video-posters/vFXhHIvNgSwdjUa7Pv00wjCvN514HND1ata2JxDqcm900.jpg Découvrez le rôle du MDCG de l'UE et comment ses guides soutiennent la mise en œuvre du MDR et de l'IVDR. https://stream.mux.com/vFXhHIvNgSwdjUa7Pv00wjCvN514HND1ata2JxDqcm900.m3u8 https://player.mux.com/vFXhHIvNgSwdjUa7Pv00wjCvN514HND1ata2JxDqcm900?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FvFXhHIvNgSwdjUa7Pv00wjCvN514HND1ata2JxDqcm900.jpg&accent-color=%232451c6 109 2026-10-16T04:58:05.790Z 2026-07-27 https://www.pureglobal.com/fr/glossary/eu-mdr 2026-08-11 https://www.pureglobal.com/fr/glossary/european-commission 2026-07-24 https://www.pureglobal.com/fr/glossary/fda-21-cfr-part-11 2026-08-11 https://www.pureglobal.com/fr/glossary/fda-510k-premarket-notification 2026-08-11 https://www.pureglobal.com/fr/glossary/fda-form-483 2026-08-11 https://www.pureglobal.com/fr/glossary/fda-product-code 2026-08-11 https://www.pureglobal.com/fr/glossary/fda-recall-classes 2026-08-11 https://www.pureglobal.com/fr/glossary/fda-warning-letter 2026-08-11 https://www.pureglobal.com/fr/glossary/field-safety-corrective-action-fsca 2026-07-27 https://www.pureglobal.com/fr/glossary/general-safety-and-performance-requirements-gspr 2026-07-27 https://www.pureglobal.com/fr/glossary/gmdn 2026-07-27 https://www.pureglobal.com/fr/glossary/gudid 2026-08-11 https://www.pureglobal.com/fr/glossary/health-canada-hc Santé Canada : MDEL et MDL expliqués https://www.pureglobal.com/assets/video-posters/Elr3pp02daZ3cHrUOfyy5s2nYlMc00xm9IywdsJB1pc8A.jpg Comprenez les MDEL et MDL, les classes de dispositifs médicaux au Canada et les frais de licence présentés dans cette vidéo. https://stream.mux.com/Elr3pp02daZ3cHrUOfyy5s2nYlMc00xm9IywdsJB1pc8A.m3u8 https://player.mux.com/Elr3pp02daZ3cHrUOfyy5s2nYlMc00xm9IywdsJB1pc8A?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FElr3pp02daZ3cHrUOfyy5s2nYlMc00xm9IywdsJB1pc8A.jpg&accent-color=%232451c6 111 2026-10-16T04:57:20.641Z 2026-07-24 https://www.pureglobal.com/fr/glossary/hong-kong-mdd 2026-07-24 https://www.pureglobal.com/fr/glossary/iec-60601-1 2026-07-27 https://www.pureglobal.com/fr/glossary/iec-60601-1-2 2026-08-11 https://www.pureglobal.com/fr/glossary/iec-62304 2026-07-27 https://www.pureglobal.com/fr/glossary/iec-62366-1 2026-07-27 https://www.pureglobal.com/fr/glossary/iec-81001-5-1 2026-07-27 https://www.pureglobal.com/fr/glossary/imda IMDA Vietnam : classes de DM et enregistrement https://www.pureglobal.com/assets/video-posters/ZeTHNh2Kol01XXJq1OHedf7LxxsqvCMugJssLn2Q1Vr4.jpg Découvrez l'IMDA au Vietnam et explorez les classes A–D de dispositifs médicaux, les voies d'enregistrement et les frais. https://stream.mux.com/ZeTHNh2Kol01XXJq1OHedf7LxxsqvCMugJssLn2Q1Vr4.m3u8 https://player.mux.com/ZeTHNh2Kol01XXJq1OHedf7LxxsqvCMugJssLn2Q1Vr4?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FZeTHNh2Kol01XXJq1OHedf7LxxsqvCMugJssLn2Q1Vr4.jpg&accent-color=%232451c6 107 2026-10-16T04:57:54.771Z 2026-07-24 https://www.pureglobal.com/fr/glossary/imdrf 2026-07-27 https://www.pureglobal.com/fr/glossary/india-cdsco 2026-07-24 https://www.pureglobal.com/fr/glossary/indonesia-moh 2026-07-27 https://www.pureglobal.com/fr/glossary/inmetro 2026-07-27 https://www.pureglobal.com/fr/glossary/investigational-device-exemption-ide FDA IDE : exemptions pour dispositifs https://www.pureglobal.com/assets/video-posters/6VHfOLqokbmjvm0157534U1CEumk4LhdnLXa00ZB87XJI.jpg Découvrez comment les exemptions pour dispositifs expérimentaux s'appliquent aux études, à l'évaluation des risques et à l'accord FDA. https://stream.mux.com/6VHfOLqokbmjvm0157534U1CEumk4LhdnLXa00ZB87XJI.m3u8 https://player.mux.com/6VHfOLqokbmjvm0157534U1CEumk4LhdnLXa00ZB87XJI?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F6VHfOLqokbmjvm0157534U1CEumk4LhdnLXa00ZB87XJI.jpg&accent-color=%232451c6 107 2026-10-16T04:58:22.372Z 2026-08-11 https://www.pureglobal.com/fr/glossary/invima INVIMA : votre feuille de route DM en Colombie https://www.pureglobal.com/assets/video-posters/ZosgebXIAgy02FfiEdi3WruvkQSL3B2U23x2o2ZqFowY.jpg INVIMA est l'autorité nationale colombienne de réglementation des produits de santé. https://stream.mux.com/ZosgebXIAgy02FfiEdi3WruvkQSL3B2U23x2o2ZqFowY.m3u8 https://player.mux.com/ZosgebXIAgy02FfiEdi3WruvkQSL3B2U23x2o2ZqFowY?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FZosgebXIAgy02FfiEdi3WruvkQSL3B2U23x2o2ZqFowY.jpg&accent-color=%232451c6 132 2026-09-11T19:45:40.048Z 2026-09-11 https://www.pureglobal.com/fr/glossary/iso-10993 2026-07-27 https://www.pureglobal.com/fr/glossary/iso-11135 2026-07-27 https://www.pureglobal.com/fr/glossary/iso-11137 2026-07-27 https://www.pureglobal.com/fr/glossary/iso-11607 2026-07-27 https://www.pureglobal.com/fr/glossary/iso-13485 2026-07-27 https://www.pureglobal.com/fr/glossary/iso-14155 2026-07-27 https://www.pureglobal.com/fr/glossary/iso-14644 2026-08-11 https://www.pureglobal.com/fr/glossary/iso-14971 2026-07-27 https://www.pureglobal.com/fr/glossary/iso-15223-1 ISO 15223-1 : ce que l'étiquetage doit indiquer https://www.pureglobal.com/assets/video-posters/9BxU3KJ7vzd2t3Q02o00J1VVAKxVxx5V7VS102hcOP8J88.jpg La norme spécifie des symboles pour les informations fournies avec les dispositifs médicaux. https://stream.mux.com/9BxU3KJ7vzd2t3Q02o00J1VVAKxVxx5V7VS102hcOP8J88.m3u8 https://player.mux.com/9BxU3KJ7vzd2t3Q02o00J1VVAKxVxx5V7VS102hcOP8J88?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F9BxU3KJ7vzd2t3Q02o00J1VVAKxVxx5V7VS102hcOP8J88.jpg&accent-color=%232451c6 127 2026-09-11T19:55:53.993Z 2026-09-11 https://www.pureglobal.com/fr/glossary/iso-17665 2026-07-27 https://www.pureglobal.com/fr/glossary/iso-20417 2026-07-27 https://www.pureglobal.com/fr/glossary/israel-amar 2026-07-24 https://www.pureglobal.com/fr/glossary/japan-mhlw Japon : MHLW et PMDA, qui fait quoi ? https://www.pureglobal.com/assets/video-posters/Jjb9VNZgJ3M01cZf00g98m8kl4eGUatQoHCBlyIc00Np8s.jpg Le ministère japonais de la Santé, du Travail et des Affaires sociales détient l'autorité administrative pour l'approbation des dispositifs. https://stream.mux.com/Jjb9VNZgJ3M01cZf00g98m8kl4eGUatQoHCBlyIc00Np8s.m3u8 https://player.mux.com/Jjb9VNZgJ3M01cZf00g98m8kl4eGUatQoHCBlyIc00Np8s?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FJjb9VNZgJ3M01cZf00g98m8kl4eGUatQoHCBlyIc00Np8s.jpg&accent-color=%232451c6 138 2026-09-11T19:49:45.279Z 2026-09-11 https://www.pureglobal.com/fr/glossary/japan-pmda Japon PMDA : voies et délais d'examen https://www.pureglobal.com/assets/video-posters/dKRTxxT02r8v9kMX6ns5rG3dmEE9ap73mU5cX36R25Hw.jpg Guide vidéo : PMDA au Japon, classes de dispositifs, notification, certification, approbation ministérielle et délais d'examen. https://stream.mux.com/dKRTxxT02r8v9kMX6ns5rG3dmEE9ap73mU5cX36R25Hw.m3u8 https://player.mux.com/dKRTxxT02r8v9kMX6ns5rG3dmEE9ap73mU5cX36R25Hw?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FdKRTxxT02r8v9kMX6ns5rG3dmEE9ap73mU5cX36R25Hw.jpg&accent-color=%232451c6 103 2026-10-16T04:56:46.728Z 2026-07-24 https://www.pureglobal.com/fr/glossary/laboratory-developed-test-ldt 2026-08-11 https://www.pureglobal.com/fr/glossary/macau-isaf 2026-07-24 https://www.pureglobal.com/fr/glossary/malaysia-mda MDA Malaisie : réglementation des dispositifs médicaux https://www.pureglobal.com/assets/video-posters/11KfReMlINv12OFt8uFn4qlyx300rCqE02ukcSqql4XFI.jpg Aperçu de la Medical Device Authority de Malaisie, enregistrement des dispositifs, représentation locale et redevances de classe A. https://stream.mux.com/11KfReMlINv12OFt8uFn4qlyx300rCqE02ukcSqql4XFI.m3u8 https://player.mux.com/11KfReMlINv12OFt8uFn4qlyx300rCqE02ukcSqql4XFI?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F11KfReMlINv12OFt8uFn4qlyx300rCqE02ukcSqql4XFI.jpg&accent-color=%232451c6 110 2026-10-16T04:56:46.830Z 2026-07-24 https://www.pureglobal.com/fr/glossary/maude-database 2026-08-11 https://www.pureglobal.com/fr/glossary/mdall 2026-08-11 https://www.pureglobal.com/fr/glossary/mdsap 2026-07-27 https://www.pureglobal.com/fr/glossary/medical-device-classification 2026-07-27 https://www.pureglobal.com/fr/glossary/medical-device-reporting-mdr 2026-08-11 https://www.pureglobal.com/fr/glossary/medical-device-technical-file 2026-07-27 https://www.pureglobal.com/fr/glossary/medsafe 2026-07-24 https://www.pureglobal.com/fr/glossary/medwatch 2026-08-11 https://www.pureglobal.com/fr/glossary/mexico-general-health-law La Loi générale de santé du Mexique expliquée https://www.pureglobal.com/assets/video-posters/dgX01chIlN4oUiAVheidWYONE01Waje9IuAV6CvpVEA6Y.jpg Introduction pratique pour les équipes de dispositifs médicaux : cadre légal, rôle de COFEPRIS et trois contrôles avant de planifier une soumission. https://stream.mux.com/dgX01chIlN4oUiAVheidWYONE01Waje9IuAV6CvpVEA6Y.m3u8 https://player.mux.com/dgX01chIlN4oUiAVheidWYONE01Waje9IuAV6CvpVEA6Y?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FdgX01chIlN4oUiAVheidWYONE01Waje9IuAV6CvpVEA6Y.jpg&accent-color=%232451c6 123 2026-09-11T05:30:32.911Z 2026-09-11 https://www.pureglobal.com/fr/glossary/mhra MHRA : règles des DM au Royaume-Uni https://www.pureglobal.com/assets/video-posters/PiCcyO02oZcLiqy7n3tHnXD2lZRah9m01cMKWrB67HxIY.jpg Un guide sur MHRA, la réglementation des dispositifs médicaux au Royaume-Uni et les voies de marquage CE et UKCA abordées. https://stream.mux.com/PiCcyO02oZcLiqy7n3tHnXD2lZRah9m01cMKWrB67HxIY.m3u8 https://player.mux.com/PiCcyO02oZcLiqy7n3tHnXD2lZRah9m01cMKWrB67HxIY?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FPiCcyO02oZcLiqy7n3tHnXD2lZRah9m01cMKWrB67HxIY.jpg&accent-color=%232451c6 107 2026-10-16T04:57:38.088Z 2026-07-24 https://www.pureglobal.com/fr/glossary/notified-body 2026-08-11 https://www.pureglobal.com/fr/glossary/pakistan-drap 2026-07-24 https://www.pureglobal.com/fr/glossary/periodic-safety-update-report-psur 2026-07-27 https://www.pureglobal.com/fr/glossary/peru-digemid 2026-07-24 https://www.pureglobal.com/fr/glossary/philippines-fda 2026-07-24 https://www.pureglobal.com/fr/glossary/post-market-surveillance-pms 2026-08-11 https://www.pureglobal.com/fr/glossary/predicate-device 2026-08-11 https://www.pureglobal.com/fr/glossary/premarket-approval-pma 2026-08-11 https://www.pureglobal.com/fr/glossary/qmsr 2026-07-24 https://www.pureglobal.com/fr/glossary/quality-management-system-qms 2026-08-11 https://www.pureglobal.com/fr/glossary/rdc-751-2022 Brésil RDC 751 : classification, dossier et étiquetage https://www.pureglobal.com/assets/video-posters/dH82EpiGiKGSWVAvwVIWbgGpfg76bbM5gkKy02Nh7NAU.jpg La résolution est entrée en vigueur en mars deux mille vingt-trois. https://stream.mux.com/dH82EpiGiKGSWVAvwVIWbgGpfg76bbM5gkKy02Nh7NAU.m3u8 https://player.mux.com/dH82EpiGiKGSWVAvwVIWbgGpfg76bbM5gkKy02Nh7NAU?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FdH82EpiGiKGSWVAvwVIWbgGpfg76bbM5gkKy02Nh7NAU.jpg&accent-color=%232451c6 137 2026-09-11T20:04:25.891Z 2026-09-11 https://www.pureglobal.com/fr/glossary/rdc-830-2023 2026-07-27 https://www.pureglobal.com/fr/glossary/saudi-sfda SFDA saoudienne : autorisation des dispositifs et rôles locaux https://www.pureglobal.com/assets/video-posters/1fU01Arpp01DWi8qAJbWw02Z9zzP3866Uk02srYeRyRN00lA.jpg La Saudi Food and Drug Authority réglemente les dispositifs médicaux et les diagnostics in vitro. https://stream.mux.com/1fU01Arpp01DWi8qAJbWw02Z9zzP3866Uk02srYeRyRN00lA.m3u8 https://player.mux.com/1fU01Arpp01DWi8qAJbWw02Z9zzP3866Uk02srYeRyRN00lA?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F1fU01Arpp01DWi8qAJbWw02Z9zzP3866Uk02srYeRyRN00lA.jpg&accent-color=%232451c6 136 2026-09-11T20:02:16.212Z 2026-09-11 https://www.pureglobal.com/fr/glossary/singapore-hsa Singapour HSA : choisir la voie du dispositif https://www.pureglobal.com/assets/video-posters/001rWy1Oi7PGVhrXlnlSVA5vVpRBqOrphRVYq3UfZD400.jpg HSA est la Health Sciences Authority de Singapour. https://stream.mux.com/001rWy1Oi7PGVhrXlnlSVA5vVpRBqOrphRVYq3UfZD400.m3u8 https://player.mux.com/001rWy1Oi7PGVhrXlnlSVA5vVpRBqOrphRVYq3UfZD400?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F001rWy1Oi7PGVhrXlnlSVA5vVpRBqOrphRVYq3UfZD400.jpg&accent-color=%232451c6 140 2026-09-11T20:00:08.754Z 2026-09-11 https://www.pureglobal.com/fr/glossary/south-korea-mfds 2026-07-24 https://www.pureglobal.com/fr/glossary/swissmedic 2026-07-24 https://www.pureglobal.com/fr/glossary/taiwan-tfda 2026-07-24 https://www.pureglobal.com/fr/glossary/thailand-fda FDA thaïlandaise : checklist pratique de lancement https://www.pureglobal.com/assets/video-posters/hseJ6HtJ5027kH1KsIp5pvuQRlhUwdgBkXM01Zp02evRSY.jpg La FDA thaïlandaise régule les produits de santé sous la tutelle du ministère de la Santé publique. https://stream.mux.com/hseJ6HtJ5027kH1KsIp5pvuQRlhUwdgBkXM01Zp02evRSY.m3u8 https://player.mux.com/hseJ6HtJ5027kH1KsIp5pvuQRlhUwdgBkXM01Zp02evRSY?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FhseJ6HtJ5027kH1KsIp5pvuQRlhUwdgBkXM01Zp02evRSY.jpg&accent-color=%232451c6 129 2026-09-11T19:51:47.092Z 2026-09-11 https://www.pureglobal.com/fr/glossary/uae-ede 2026-07-24 https://www.pureglobal.com/fr/glossary/ukca-marking 2026-08-11 https://www.pureglobal.com/fr/glossary/unique-device-identification-udi 2026-07-27 https://www.pureglobal.com/fr/glossary/us-fda US FDA : réglementation des dispositifs https://www.pureglobal.com/assets/video-posters/J7lElt7fst3xxIh2KjnM81YMqzOVealMu7YBI5ypv1c.jpg Introduction à FDA et au CDRH, classes de risque des dispositifs médicaux, voies de soumission et redevances utilisateurs. https://stream.mux.com/J7lElt7fst3xxIh2KjnM81YMqzOVealMu7YBI5ypv1c.m3u8 https://player.mux.com/J7lElt7fst3xxIh2KjnM81YMqzOVealMu7YBI5ypv1c?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FJ7lElt7fst3xxIh2KjnM81YMqzOVealMu7YBI5ypv1c.jpg&accent-color=%232451c6 118 2026-10-16T04:57:21.163Z 2026-07-24 https://www.pureglobal.com/fr/glossary/vietnam-moh 2026-07-24 https://www.pureglobal.com/fr/glossary/what-is-eudamed 2026-07-24 https://www.pureglobal.com/fr/glossary/what-is-swissdamed 2026-10-15 https://www.pureglobal.com/fr/glossary/what-is-the-artg ARTG Australie : sponsors et frais TGA https://www.pureglobal.com/assets/video-posters/ctdHI00Tr9g6pU1RmSJtpiyysaG7vvsZeEA02y01TOsHhg.jpg Découvrez ce que couvre l'ARTG en Australie et comment s'articulent sponsors, enregistrement des dispositifs et frais TGA. https://stream.mux.com/ctdHI00Tr9g6pU1RmSJtpiyysaG7vvsZeEA02y01TOsHhg.m3u8 https://player.mux.com/ctdHI00Tr9g6pU1RmSJtpiyysaG7vvsZeEA02y01TOsHhg?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FctdHI00Tr9g6pU1RmSJtpiyysaG7vvsZeEA02y01TOsHhg.jpg&accent-color=%232451c6 115 2026-10-16T04:57:03.866Z 2026-07-24 https://www.pureglobal.com/fr/glossary/what-is-the-therapeutic-goods-act-1989-australia 2026-07-27 https://www.pureglobal.com/glossary/anatel Brazil ANATEL: Does Your Device Need It? https://www.pureglobal.com/assets/video-posters/2kjDRrmC01o02EgPyoQIq01AWl3wjZamMzEKd00cpxiM8UY.jpg Learn when a connected medical device may need ANATEL radio homologation in Brazil and what the process involves. https://stream.mux.com/2kjDRrmC01o02EgPyoQIq01AWl3wjZamMzEKd00cpxiM8UY.m3u8 https://player.mux.com/2kjDRrmC01o02EgPyoQIq01AWl3wjZamMzEKd00cpxiM8UY?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F2kjDRrmC01o02EgPyoQIq01AWl3wjZamMzEKd00cpxiM8UY.jpg&accent-color=%232451c6 107 2026-10-16T04:57:36.091Z 2026-07-27 https://www.pureglobal.com/glossary/anmat 2026-07-24 https://www.pureglobal.com/glossary/anvisa ANVISA: What Brazil Device Teams Need to Know https://www.pureglobal.com/assets/video-posters/hHl6hszm3En7VfYLPg1FTY6yJGo4aRB5wG6Pob018q02o.jpg ANVISA is Brazil’s health regulatory agency. https://stream.mux.com/hHl6hszm3En7VfYLPg1FTY6yJGo4aRB5wG6Pob018q02o.m3u8 https://player.mux.com/hHl6hszm3En7VfYLPg1FTY6yJGo4aRB5wG6Pob018q02o?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FhHl6hszm3En7VfYLPg1FTY6yJGo4aRB5wG6Pob018q02o.jpg&accent-color=%232451c6 123 2026-09-11T19:46:19.832Z 2026-09-11 https://www.pureglobal.com/glossary/asean-csdt 2026-07-27 https://www.pureglobal.com/glossary/asean-medical-device-directive-amdd 2026-07-27 https://www.pureglobal.com/glossary/australia-tga 2026-07-24 https://www.pureglobal.com/glossary/bangladesh-dgda 2026-07-24 https://www.pureglobal.com/glossary/breakthrough-devices-program 2026-08-11 https://www.pureglobal.com/glossary/ce-marking 2026-08-11 https://www.pureglobal.com/glossary/certificate-of-free-sale 2026-07-27 https://www.pureglobal.com/glossary/china-nmpa 2026-07-24 https://www.pureglobal.com/glossary/clia-waiver 2026-08-11 https://www.pureglobal.com/glossary/cofepris COFEPRIS: What Mexico Device Teams Should Check https://www.pureglobal.com/assets/video-posters/M02cIDpQS4XIg6nmjx9bUmnQp3YsVABamQYcCBXbhQaM.jpg COFEPRIS is Mexico’s federal health-risk regulator under the Ministry of Health. https://stream.mux.com/M02cIDpQS4XIg6nmjx9bUmnQp3YsVABamQYcCBXbhQaM.m3u8 https://player.mux.com/M02cIDpQS4XIg6nmjx9bUmnQp3YsVABamQYcCBXbhQaM?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FM02cIDpQS4XIg6nmjx9bUmnQp3YsVABamQYcCBXbhQaM.jpg&accent-color=%232451c6 126 2026-09-11T19:52:27.565Z 2026-09-11 https://www.pureglobal.com/glossary/combination-product 2026-08-11 https://www.pureglobal.com/glossary/companion-diagnostics 2026-08-11 https://www.pureglobal.com/glossary/conformity-assessment 2026-07-27 https://www.pureglobal.com/glossary/corrective-and-preventive-action-capa 2026-08-11 https://www.pureglobal.com/glossary/costa-rica-ministry-of-health 2026-07-24 https://www.pureglobal.com/glossary/current-good-manufacturing-practice-cgmp 2026-08-11 https://www.pureglobal.com/glossary/de-novo-classification 2026-08-11 https://www.pureglobal.com/glossary/decree-3770-of-2004 2026-07-27 https://www.pureglobal.com/glossary/decree-4725-2005 Colombia Decree 4725: Map the Device Requirements https://www.pureglobal.com/assets/video-posters/FV3S91Zw24mP00DEKdBTqWmyZ02N02NgMWUtAs02ypzKj500.jpg Issued in two thousand five, the decree governs medical devices for human use in Colombia. https://stream.mux.com/FV3S91Zw24mP00DEKdBTqWmyZ02N02NgMWUtAs02ypzKj500.m3u8 https://player.mux.com/FV3S91Zw24mP00DEKdBTqWmyZ02N02NgMWUtAs02ypzKj500?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FFV3S91Zw24mP00DEKdBTqWmyZ02N02NgMWUtAs02ypzKj500.jpg&accent-color=%232451c6 131 2026-09-11T19:56:34.188Z 2026-09-11 https://www.pureglobal.com/glossary/design-controls 2026-08-11 https://www.pureglobal.com/glossary/design-history-file-dhf 2026-08-11 https://www.pureglobal.com/glossary/egypt-eda 2026-07-24 https://www.pureglobal.com/glossary/electronic-instructions-for-use-eifu 2026-08-11 https://www.pureglobal.com/glossary/eu-declaration-of-conformity 2026-07-27 https://www.pureglobal.com/glossary/eu-mdcg MDCG: EU Medical Device Guidance https://www.pureglobal.com/assets/video-posters/vFXhHIvNgSwdjUa7Pv00wjCvN514HND1ata2JxDqcm900.jpg Learn what the EU Medical Device Coordination Group does and how its guidance supports MDR and IVDR implementation. https://stream.mux.com/vFXhHIvNgSwdjUa7Pv00wjCvN514HND1ata2JxDqcm900.m3u8 https://player.mux.com/vFXhHIvNgSwdjUa7Pv00wjCvN514HND1ata2JxDqcm900?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FvFXhHIvNgSwdjUa7Pv00wjCvN514HND1ata2JxDqcm900.jpg&accent-color=%232451c6 109 2026-10-16T04:58:05.790Z 2026-07-27 https://www.pureglobal.com/glossary/eu-mdr 2026-08-11 https://www.pureglobal.com/glossary/european-commission 2026-07-24 https://www.pureglobal.com/glossary/fda-21-cfr-part-11 2026-08-11 https://www.pureglobal.com/glossary/fda-510k-premarket-notification 2026-08-11 https://www.pureglobal.com/glossary/fda-form-483 2026-08-11 https://www.pureglobal.com/glossary/fda-product-code 2026-08-11 https://www.pureglobal.com/glossary/fda-recall-classes 2026-08-11 https://www.pureglobal.com/glossary/fda-warning-letter 2026-08-11 https://www.pureglobal.com/glossary/field-safety-corrective-action-fsca 2026-07-27 https://www.pureglobal.com/glossary/general-safety-and-performance-requirements-gspr 2026-07-27 https://www.pureglobal.com/glossary/gmdn 2026-07-27 https://www.pureglobal.com/glossary/gudid 2026-08-11 https://www.pureglobal.com/glossary/health-canada-hc Health Canada: MDEL and MDL Explained https://www.pureglobal.com/assets/video-posters/Elr3pp02daZ3cHrUOfyy5s2nYlMc00xm9IywdsJB1pc8A.jpg Understand MDEL and MDL, Canada's medical device classes and the licensing fees covered in this video. https://stream.mux.com/Elr3pp02daZ3cHrUOfyy5s2nYlMc00xm9IywdsJB1pc8A.m3u8 https://player.mux.com/Elr3pp02daZ3cHrUOfyy5s2nYlMc00xm9IywdsJB1pc8A?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FElr3pp02daZ3cHrUOfyy5s2nYlMc00xm9IywdsJB1pc8A.jpg&accent-color=%232451c6 111 2026-10-16T04:57:20.641Z 2026-07-24 https://www.pureglobal.com/glossary/hong-kong-mdd 2026-07-24 https://www.pureglobal.com/glossary/iec-60601-1 2026-07-27 https://www.pureglobal.com/glossary/iec-60601-1-2 2026-08-11 https://www.pureglobal.com/glossary/iec-62304 2026-07-27 https://www.pureglobal.com/glossary/iec-62366-1 2026-07-27 https://www.pureglobal.com/glossary/iec-81001-5-1 2026-07-27 https://www.pureglobal.com/glossary/imda Vietnam IMDA: Device Classes and Registration https://www.pureglobal.com/assets/video-posters/ZeTHNh2Kol01XXJq1OHedf7LxxsqvCMugJssLn2Q1Vr4.jpg Meet Vietnam's IMDA and explore medical device classes A–D, registration routes and fees. https://stream.mux.com/ZeTHNh2Kol01XXJq1OHedf7LxxsqvCMugJssLn2Q1Vr4.m3u8 https://player.mux.com/ZeTHNh2Kol01XXJq1OHedf7LxxsqvCMugJssLn2Q1Vr4?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FZeTHNh2Kol01XXJq1OHedf7LxxsqvCMugJssLn2Q1Vr4.jpg&accent-color=%232451c6 107 2026-10-16T04:57:54.771Z 2026-07-24 https://www.pureglobal.com/glossary/imdrf 2026-07-27 https://www.pureglobal.com/glossary/india-cdsco 2026-07-24 https://www.pureglobal.com/glossary/indonesia-moh 2026-07-27 https://www.pureglobal.com/glossary/inmetro 2026-07-27 https://www.pureglobal.com/glossary/investigational-device-exemption-ide FDA IDE: Investigational Device Exemptions https://www.pureglobal.com/assets/video-posters/6VHfOLqokbmjvm0157534U1CEumk4LhdnLXa00ZB87XJI.jpg Learn how investigational device exemptions apply to device studies, risk determinations and FDA approval. https://stream.mux.com/6VHfOLqokbmjvm0157534U1CEumk4LhdnLXa00ZB87XJI.m3u8 https://player.mux.com/6VHfOLqokbmjvm0157534U1CEumk4LhdnLXa00ZB87XJI?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F6VHfOLqokbmjvm0157534U1CEumk4LhdnLXa00ZB87XJI.jpg&accent-color=%232451c6 107 2026-10-16T04:58:22.372Z 2026-08-11 https://www.pureglobal.com/glossary/invima INVIMA: Your Colombia Device Roadmap https://www.pureglobal.com/assets/video-posters/Yi3FI27KMwiR02OJf01k3iDU00gET5iGSmXCVI7pZj02K02Q.jpg INVIMA is Colombia’s national health-product regulator. https://stream.mux.com/Yi3FI27KMwiR02OJf01k3iDU00gET5iGSmXCVI7pZj02K02Q.m3u8 https://player.mux.com/Yi3FI27KMwiR02OJf01k3iDU00gET5iGSmXCVI7pZj02K02Q?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FYi3FI27KMwiR02OJf01k3iDU00gET5iGSmXCVI7pZj02K02Q.jpg&accent-color=%232451c6 121 2026-09-11T19:44:23.331Z 2026-09-11 https://www.pureglobal.com/glossary/iso-10993 2026-07-27 https://www.pureglobal.com/glossary/iso-11135 2026-07-27 https://www.pureglobal.com/glossary/iso-11137 2026-07-27 https://www.pureglobal.com/glossary/iso-11607 2026-07-27 https://www.pureglobal.com/glossary/iso-13485 2026-07-27 https://www.pureglobal.com/glossary/iso-14155 2026-07-27 https://www.pureglobal.com/glossary/iso-14644 2026-08-11 https://www.pureglobal.com/glossary/iso-14971 2026-07-27 https://www.pureglobal.com/glossary/iso-15223-1 ISO 15223-1: What Device Labels Need to Say https://www.pureglobal.com/assets/video-posters/byrM4PgSt1BEXKujYTCE025OVUnzcUinMYMAqyt17IlU.jpg The standard specifies symbols for information supplied with medical devices. https://stream.mux.com/byrM4PgSt1BEXKujYTCE025OVUnzcUinMYMAqyt17IlU.m3u8 https://player.mux.com/byrM4PgSt1BEXKujYTCE025OVUnzcUinMYMAqyt17IlU?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FbyrM4PgSt1BEXKujYTCE025OVUnzcUinMYMAqyt17IlU.jpg&accent-color=%232451c6 129 2026-09-11T19:54:29.453Z 2026-09-11 https://www.pureglobal.com/glossary/iso-17665 2026-07-27 https://www.pureglobal.com/glossary/iso-20417 2026-07-27 https://www.pureglobal.com/glossary/israel-amar 2026-07-24 https://www.pureglobal.com/glossary/japan-mhlw Japan MHLW and PMDA: Who Does What? https://www.pureglobal.com/assets/video-posters/6PKOZyX1yGDF6tm9qcgr2G4IrTpal02M01tego4z5BKNw.jpg MHLW is Japan’s Ministry of Health, Labour and Welfare. https://stream.mux.com/6PKOZyX1yGDF6tm9qcgr2G4IrTpal02M01tego4z5BKNw.m3u8 https://player.mux.com/6PKOZyX1yGDF6tm9qcgr2G4IrTpal02M01tego4z5BKNw?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F6PKOZyX1yGDF6tm9qcgr2G4IrTpal02M01tego4z5BKNw.jpg&accent-color=%232451c6 131 2026-09-11T19:48:22.803Z 2026-09-11 https://www.pureglobal.com/glossary/japan-pmda Japan PMDA: Device Routes and Review Times https://www.pureglobal.com/assets/video-posters/dKRTxxT02r8v9kMX6ns5rG3dmEE9ap73mU5cX36R25Hw.jpg A video guide to Japan's PMDA, device classes, notification, certification, ministry approval and review timelines. https://stream.mux.com/dKRTxxT02r8v9kMX6ns5rG3dmEE9ap73mU5cX36R25Hw.m3u8 https://player.mux.com/dKRTxxT02r8v9kMX6ns5rG3dmEE9ap73mU5cX36R25Hw?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FdKRTxxT02r8v9kMX6ns5rG3dmEE9ap73mU5cX36R25Hw.jpg&accent-color=%232451c6 103 2026-10-16T04:56:46.728Z 2026-07-24 https://www.pureglobal.com/glossary/laboratory-developed-test-ldt 2026-08-11 https://www.pureglobal.com/glossary/macau-isaf 2026-07-24 https://www.pureglobal.com/glossary/malaysia-mda Malaysia MDA: Medical Device Regulation https://www.pureglobal.com/assets/video-posters/11KfReMlINv12OFt8uFn4qlyx300rCqE02ukcSqql4XFI.jpg An overview of Malaysia's Medical Device Authority, device registration, local representation and Class A fees. https://stream.mux.com/11KfReMlINv12OFt8uFn4qlyx300rCqE02ukcSqql4XFI.m3u8 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practical introduction for medical device teams: the legal framework, the role of COFEPRIS and three checks to make before planning a submission. https://stream.mux.com/i02ImEwSW02j4BZC8ftyYGnSd7YPg3AiLP01wn8SKwgYME.m3u8 https://player.mux.com/i02ImEwSW02j4BZC8ftyYGnSd7YPg3AiLP01wn8SKwgYME?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2Fi02ImEwSW02j4BZC8ftyYGnSd7YPg3AiLP01wn8SKwgYME.jpg&accent-color=%232451c6 115 2026-09-11T04:39:08.586Z 2026-09-11 https://www.pureglobal.com/glossary/mhra MHRA: UK Medical Device Rules https://www.pureglobal.com/assets/video-posters/PiCcyO02oZcLiqy7n3tHnXD2lZRah9m01cMKWrB67HxIY.jpg A guide to the MHRA, UK medical device regulation and the CE and UKCA marking pathways discussed in this video. https://stream.mux.com/PiCcyO02oZcLiqy7n3tHnXD2lZRah9m01cMKWrB67HxIY.m3u8 https://player.mux.com/PiCcyO02oZcLiqy7n3tHnXD2lZRah9m01cMKWrB67HxIY?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FPiCcyO02oZcLiqy7n3tHnXD2lZRah9m01cMKWrB67HxIY.jpg&accent-color=%232451c6 107 2026-10-16T04:57:38.088Z 2026-07-24 https://www.pureglobal.com/glossary/notified-body 2026-08-11 https://www.pureglobal.com/glossary/pakistan-drap 2026-07-24 https://www.pureglobal.com/glossary/periodic-safety-update-report-psur 2026-07-27 https://www.pureglobal.com/glossary/peru-digemid 2026-07-24 https://www.pureglobal.com/glossary/philippines-fda 2026-07-24 https://www.pureglobal.com/glossary/post-market-surveillance-pms 2026-08-11 https://www.pureglobal.com/glossary/predicate-device 2026-08-11 https://www.pureglobal.com/glossary/premarket-approval-pma 2026-08-11 https://www.pureglobal.com/glossary/qmsr 2026-07-24 https://www.pureglobal.com/glossary/quality-management-system-qms 2026-08-11 https://www.pureglobal.com/glossary/rdc-751-2022 Brazil RDC 751: Classification, Dossier and Labeling https://www.pureglobal.com/assets/video-posters/q01CkGj38ynaMdYLkUyhKQ01e86h01A9fVeWrcKJezd4j00.jpg The resolution took effect in March twenty twenty-three. https://stream.mux.com/q01CkGj38ynaMdYLkUyhKQ01e86h01A9fVeWrcKJezd4j00.m3u8 https://player.mux.com/q01CkGj38ynaMdYLkUyhKQ01e86h01A9fVeWrcKJezd4j00?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2Fq01CkGj38ynaMdYLkUyhKQ01e86h01A9fVeWrcKJezd4j00.jpg&accent-color=%232451c6 129 2026-09-11T20:02:58.293Z 2026-09-11 https://www.pureglobal.com/glossary/rdc-830-2023 2026-07-27 https://www.pureglobal.com/glossary/saudi-sfda Saudi SFDA: Device Authorization and Local Roles https://www.pureglobal.com/assets/video-posters/n6vRupniH1ses00Uwxn2dRYRXZbn63QX6u9qjXgB01hyw.jpg The Saudi Food and Drug Authority regulates medical devices and in vitro diagnostics. https://stream.mux.com/n6vRupniH1ses00Uwxn2dRYRXZbn63QX6u9qjXgB01hyw.m3u8 https://player.mux.com/n6vRupniH1ses00Uwxn2dRYRXZbn63QX6u9qjXgB01hyw?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2Fn6vRupniH1ses00Uwxn2dRYRXZbn63QX6u9qjXgB01hyw.jpg&accent-color=%232451c6 129 2026-09-11T20:00:48.176Z 2026-09-11 https://www.pureglobal.com/glossary/singapore-hsa Singapore HSA: How to Choose a Device Route https://www.pureglobal.com/assets/video-posters/1DcaerojjOYNUB5cSJ1vRz02AVrSKD3NeY4H8d7mNrxQ.jpg HSA is Singapore’s Health Sciences Authority. https://stream.mux.com/1DcaerojjOYNUB5cSJ1vRz02AVrSKD3NeY4H8d7mNrxQ.m3u8 https://player.mux.com/1DcaerojjOYNUB5cSJ1vRz02AVrSKD3NeY4H8d7mNrxQ?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F1DcaerojjOYNUB5cSJ1vRz02AVrSKD3NeY4H8d7mNrxQ.jpg&accent-color=%232451c6 126 2026-09-11T19:58:50.736Z 2026-09-11 https://www.pureglobal.com/glossary/south-korea-mfds 2026-07-24 https://www.pureglobal.com/glossary/swissmedic 2026-07-24 https://www.pureglobal.com/glossary/taiwan-tfda 2026-07-24 https://www.pureglobal.com/glossary/thailand-fda Thai FDA: A Practical Device Launch Checklist https://www.pureglobal.com/assets/video-posters/o64IciF3Zc6thitIcqQbFVwX5GMdfIhsOp99dOs015wQ.jpg The Thai FDA regulates health products under the Ministry of Public Health. https://stream.mux.com/o64IciF3Zc6thitIcqQbFVwX5GMdfIhsOp99dOs015wQ.m3u8 https://player.mux.com/o64IciF3Zc6thitIcqQbFVwX5GMdfIhsOp99dOs015wQ?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2Fo64IciF3Zc6thitIcqQbFVwX5GMdfIhsOp99dOs015wQ.jpg&accent-color=%232451c6 119 2026-09-11T19:50:25.336Z 2026-09-11 https://www.pureglobal.com/glossary/uae-ede 2026-07-24 https://www.pureglobal.com/glossary/ukca-marking 2026-08-11 https://www.pureglobal.com/glossary/unique-device-identification-udi 2026-07-27 https://www.pureglobal.com/glossary/us-fda US FDA: Medical Device Regulation https://www.pureglobal.com/assets/video-posters/J7lElt7fst3xxIh2KjnM81YMqzOVealMu7YBI5ypv1c.jpg An introduction to FDA and CDRH, medical device risk classes, submission routes and user fees. https://stream.mux.com/J7lElt7fst3xxIh2KjnM81YMqzOVealMu7YBI5ypv1c.m3u8 https://player.mux.com/J7lElt7fst3xxIh2KjnM81YMqzOVealMu7YBI5ypv1c?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FJ7lElt7fst3xxIh2KjnM81YMqzOVealMu7YBI5ypv1c.jpg&accent-color=%232451c6 118 2026-10-16T04:57:21.163Z 2026-07-24 https://www.pureglobal.com/glossary/vietnam-moh 2026-07-24 https://www.pureglobal.com/glossary/what-is-eudamed 2026-07-24 https://www.pureglobal.com/glossary/what-is-swissdamed 2026-10-15 https://www.pureglobal.com/glossary/what-is-the-artg Australia ARTG: Sponsors and TGA Fees https://www.pureglobal.com/assets/video-posters/ctdHI00Tr9g6pU1RmSJtpiyysaG7vvsZeEA02y01TOsHhg.jpg Learn what Australia's ARTG covers and how device sponsors, registration and TGA fees fit together. https://stream.mux.com/ctdHI00Tr9g6pU1RmSJtpiyysaG7vvsZeEA02y01TOsHhg.m3u8 https://player.mux.com/ctdHI00Tr9g6pU1RmSJtpiyysaG7vvsZeEA02y01TOsHhg?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FctdHI00Tr9g6pU1RmSJtpiyysaG7vvsZeEA02y01TOsHhg.jpg&accent-color=%232451c6 115 2026-10-16T04:57:03.866Z 2026-07-24 https://www.pureglobal.com/glossary/what-is-the-therapeutic-goods-act-1989-australia 2026-07-27 https://www.pureglobal.com/it/glossary/anatel Brasile ANATEL: serve al tuo dispositivo? https://www.pureglobal.com/assets/video-posters/2kjDRrmC01o02EgPyoQIq01AWl3wjZamMzEKd00cpxiM8UY.jpg Scopri quando un dispositivo medico connesso richiede l'omologazione radio ANATEL in Brasile e cosa prevede la procedura. https://stream.mux.com/2kjDRrmC01o02EgPyoQIq01AWl3wjZamMzEKd00cpxiM8UY.m3u8 https://player.mux.com/2kjDRrmC01o02EgPyoQIq01AWl3wjZamMzEKd00cpxiM8UY?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F2kjDRrmC01o02EgPyoQIq01AWl3wjZamMzEKd00cpxiM8UY.jpg&accent-color=%232451c6 107 2026-10-16T04:57:36.091Z 2026-07-27 https://www.pureglobal.com/it/glossary/anmat 2026-07-24 https://www.pureglobal.com/it/glossary/anvisa ANVISA: cosa devono sapere i team di dispositivi in Brasile https://www.pureglobal.com/assets/video-posters/RUn7XPYtLcW5XGXkBGAZVz3KA76hbSWtw98hnMAgPPY.jpg ANVISA è l'agenzia regolatoria sanitaria del Brasile. https://stream.mux.com/RUn7XPYtLcW5XGXkBGAZVz3KA76hbSWtw98hnMAgPPY.m3u8 https://player.mux.com/RUn7XPYtLcW5XGXkBGAZVz3KA76hbSWtw98hnMAgPPY?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FRUn7XPYtLcW5XGXkBGAZVz3KA76hbSWtw98hnMAgPPY.jpg&accent-color=%232451c6 131 2026-09-11T19:47:54.553Z 2026-09-11 https://www.pureglobal.com/it/glossary/asean-csdt 2026-07-27 https://www.pureglobal.com/it/glossary/asean-medical-device-directive-amdd 2026-07-27 https://www.pureglobal.com/it/glossary/australia-tga 2026-07-24 https://www.pureglobal.com/it/glossary/bangladesh-dgda 2026-07-24 https://www.pureglobal.com/it/glossary/breakthrough-devices-program 2026-08-11 https://www.pureglobal.com/it/glossary/ce-marking 2026-08-11 https://www.pureglobal.com/it/glossary/certificate-of-free-sale 2026-07-27 https://www.pureglobal.com/it/glossary/china-nmpa 2026-07-24 https://www.pureglobal.com/it/glossary/clia-waiver 2026-08-11 https://www.pureglobal.com/it/glossary/cofepris COFEPRIS: cosa verificare per i dispositivi in Messico https://www.pureglobal.com/assets/video-posters/K5zUsRgA9LXWCGfEsiJ5osqjiBLiRRu7WO7vxe021RIY.jpg COFEPRIS è l'autorità federale messicana per i rischi sanitari, afferente al Ministero della Salute. https://stream.mux.com/K5zUsRgA9LXWCGfEsiJ5osqjiBLiRRu7WO7vxe021RIY.m3u8 https://player.mux.com/K5zUsRgA9LXWCGfEsiJ5osqjiBLiRRu7WO7vxe021RIY?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FK5zUsRgA9LXWCGfEsiJ5osqjiBLiRRu7WO7vxe021RIY.jpg&accent-color=%232451c6 141 2026-09-11T19:54:00.745Z 2026-09-11 https://www.pureglobal.com/it/glossary/combination-product 2026-08-11 https://www.pureglobal.com/it/glossary/companion-diagnostics 2026-08-11 https://www.pureglobal.com/it/glossary/conformity-assessment 2026-07-27 https://www.pureglobal.com/it/glossary/corrective-and-preventive-action-capa 2026-08-11 https://www.pureglobal.com/it/glossary/costa-rica-ministry-of-health 2026-07-24 https://www.pureglobal.com/it/glossary/current-good-manufacturing-practice-cgmp 2026-08-11 https://www.pureglobal.com/it/glossary/de-novo-classification 2026-08-11 https://www.pureglobal.com/it/glossary/decree-3770-of-2004 2026-07-27 https://www.pureglobal.com/it/glossary/decree-4725-2005 Decreto 4725 Colombia: requisiti dei dispositivi https://www.pureglobal.com/assets/video-posters/19gH011b9YhJh5eZfLQd2i2aZWz81006B1Fs01UpgP2UGA.jpg Emanato nel duemilacinque, il decreto disciplina i dispositivi medici per uso umano in Colombia. https://stream.mux.com/19gH011b9YhJh5eZfLQd2i2aZWz81006B1Fs01UpgP2UGA.m3u8 https://player.mux.com/19gH011b9YhJh5eZfLQd2i2aZWz81006B1Fs01UpgP2UGA?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F19gH011b9YhJh5eZfLQd2i2aZWz81006B1Fs01UpgP2UGA.jpg&accent-color=%232451c6 150 2026-09-11T19:58:22.268Z 2026-09-11 https://www.pureglobal.com/it/glossary/design-controls 2026-08-11 https://www.pureglobal.com/it/glossary/design-history-file-dhf 2026-08-11 https://www.pureglobal.com/it/glossary/egypt-eda 2026-07-24 https://www.pureglobal.com/it/glossary/electronic-instructions-for-use-eifu 2026-08-11 https://www.pureglobal.com/it/glossary/eu-declaration-of-conformity 2026-07-27 https://www.pureglobal.com/it/glossary/eu-mdcg MDCG: linee guida UE sui dispositivi medici https://www.pureglobal.com/assets/video-posters/vFXhHIvNgSwdjUa7Pv00wjCvN514HND1ata2JxDqcm900.jpg Scopri il ruolo del Medical Device Coordination Group europeo e come le sue linee guida supportano l'attuazione di MDR e IVDR. https://stream.mux.com/vFXhHIvNgSwdjUa7Pv00wjCvN514HND1ata2JxDqcm900.m3u8 https://player.mux.com/vFXhHIvNgSwdjUa7Pv00wjCvN514HND1ata2JxDqcm900?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FvFXhHIvNgSwdjUa7Pv00wjCvN514HND1ata2JxDqcm900.jpg&accent-color=%232451c6 109 2026-10-16T04:58:05.790Z 2026-07-27 https://www.pureglobal.com/it/glossary/eu-mdr 2026-08-11 https://www.pureglobal.com/it/glossary/european-commission 2026-07-24 https://www.pureglobal.com/it/glossary/fda-21-cfr-part-11 2026-08-11 https://www.pureglobal.com/it/glossary/fda-510k-premarket-notification 2026-08-11 https://www.pureglobal.com/it/glossary/fda-form-483 2026-08-11 https://www.pureglobal.com/it/glossary/fda-product-code 2026-08-11 https://www.pureglobal.com/it/glossary/fda-recall-classes 2026-08-11 https://www.pureglobal.com/it/glossary/fda-warning-letter 2026-08-11 https://www.pureglobal.com/it/glossary/field-safety-corrective-action-fsca 2026-07-27 https://www.pureglobal.com/it/glossary/general-safety-and-performance-requirements-gspr 2026-07-27 https://www.pureglobal.com/it/glossary/gmdn 2026-07-27 https://www.pureglobal.com/it/glossary/gudid 2026-08-11 https://www.pureglobal.com/it/glossary/health-canada-hc Health Canada: spiegazione di MDEL e MDL https://www.pureglobal.com/assets/video-posters/Elr3pp02daZ3cHrUOfyy5s2nYlMc00xm9IywdsJB1pc8A.jpg Comprendi MDEL e MDL, le classi dei dispositivi medici in Canada e le tariffe di licenza trattate in questo video. https://stream.mux.com/Elr3pp02daZ3cHrUOfyy5s2nYlMc00xm9IywdsJB1pc8A.m3u8 https://player.mux.com/Elr3pp02daZ3cHrUOfyy5s2nYlMc00xm9IywdsJB1pc8A?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FElr3pp02daZ3cHrUOfyy5s2nYlMc00xm9IywdsJB1pc8A.jpg&accent-color=%232451c6 111 2026-10-16T04:57:20.641Z 2026-07-24 https://www.pureglobal.com/it/glossary/hong-kong-mdd 2026-07-24 https://www.pureglobal.com/it/glossary/iec-60601-1 2026-07-27 https://www.pureglobal.com/it/glossary/iec-60601-1-2 2026-08-11 https://www.pureglobal.com/it/glossary/iec-62304 2026-07-27 https://www.pureglobal.com/it/glossary/iec-62366-1 2026-07-27 https://www.pureglobal.com/it/glossary/iec-81001-5-1 2026-07-27 https://www.pureglobal.com/it/glossary/imda Vietnam IMDA: classi di dispositivi e registrazione https://www.pureglobal.com/assets/video-posters/ZeTHNh2Kol01XXJq1OHedf7LxxsqvCMugJssLn2Q1Vr4.jpg Scopri l'IMDA del Vietnam ed esplora le classi di dispositivi medici A–D, i percorsi di registrazione e le tariffe. https://stream.mux.com/ZeTHNh2Kol01XXJq1OHedf7LxxsqvCMugJssLn2Q1Vr4.m3u8 https://player.mux.com/ZeTHNh2Kol01XXJq1OHedf7LxxsqvCMugJssLn2Q1Vr4?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FZeTHNh2Kol01XXJq1OHedf7LxxsqvCMugJssLn2Q1Vr4.jpg&accent-color=%232451c6 107 2026-10-16T04:57:54.771Z 2026-07-24 https://www.pureglobal.com/it/glossary/imdrf 2026-07-27 https://www.pureglobal.com/it/glossary/india-cdsco 2026-07-24 https://www.pureglobal.com/it/glossary/indonesia-moh 2026-07-27 https://www.pureglobal.com/it/glossary/inmetro 2026-07-27 https://www.pureglobal.com/it/glossary/investigational-device-exemption-ide FDA IDE: esenzioni dispositivi sperimentali https://www.pureglobal.com/assets/video-posters/6VHfOLqokbmjvm0157534U1CEumk4LhdnLXa00ZB87XJI.jpg Scopri come le esenzioni per dispositivi sperimentali si applicano a studi clinici, valutazione del rischio e approvazione FDA. https://stream.mux.com/6VHfOLqokbmjvm0157534U1CEumk4LhdnLXa00ZB87XJI.m3u8 https://player.mux.com/6VHfOLqokbmjvm0157534U1CEumk4LhdnLXa00ZB87XJI?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F6VHfOLqokbmjvm0157534U1CEumk4LhdnLXa00ZB87XJI.jpg&accent-color=%232451c6 107 2026-10-16T04:58:22.372Z 2026-08-11 https://www.pureglobal.com/it/glossary/invima INVIMA: la tua roadmap per i dispositivi in Colombia https://www.pureglobal.com/assets/video-posters/e8RAybHWjcKY1sunAegioM3L28MPDZZG0001yL023jBkSs.jpg INVIMA è l'autorità regolatoria nazionale colombiana per i prodotti sanitari. https://stream.mux.com/e8RAybHWjcKY1sunAegioM3L28MPDZZG0001yL023jBkSs.m3u8 https://player.mux.com/e8RAybHWjcKY1sunAegioM3L28MPDZZG0001yL023jBkSs?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2Fe8RAybHWjcKY1sunAegioM3L28MPDZZG0001yL023jBkSs.jpg&accent-color=%232451c6 135 2026-09-11T19:45:53.125Z 2026-09-11 https://www.pureglobal.com/it/glossary/iso-10993 2026-07-27 https://www.pureglobal.com/it/glossary/iso-11135 2026-07-27 https://www.pureglobal.com/it/glossary/iso-11137 2026-07-27 https://www.pureglobal.com/it/glossary/iso-11607 2026-07-27 https://www.pureglobal.com/it/glossary/iso-13485 2026-07-27 https://www.pureglobal.com/it/glossary/iso-14155 2026-07-27 https://www.pureglobal.com/it/glossary/iso-14644 2026-08-11 https://www.pureglobal.com/it/glossary/iso-14971 2026-07-27 https://www.pureglobal.com/it/glossary/iso-15223-1 ISO 15223-1: cosa devono riportare le etichette https://www.pureglobal.com/assets/video-posters/84bewU8kNsLfJhwOzFZlioJwhlsGksBaNB00fUOcjemo.jpg La norma specifica i simboli per le informazioni fornite con i dispositivi medici. https://stream.mux.com/84bewU8kNsLfJhwOzFZlioJwhlsGksBaNB00fUOcjemo.m3u8 https://player.mux.com/84bewU8kNsLfJhwOzFZlioJwhlsGksBaNB00fUOcjemo?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F84bewU8kNsLfJhwOzFZlioJwhlsGksBaNB00fUOcjemo.jpg&accent-color=%232451c6 141 2026-09-11T19:56:07.491Z 2026-09-11 https://www.pureglobal.com/it/glossary/iso-17665 2026-07-27 https://www.pureglobal.com/it/glossary/iso-20417 2026-07-27 https://www.pureglobal.com/it/glossary/israel-amar 2026-07-24 https://www.pureglobal.com/it/glossary/japan-mhlw Giappone, MHLW e PMDA: chi fa cosa? https://www.pureglobal.com/assets/video-posters/Y32X7wYem77LDIXvi1Kem7zF5Iym02LBmPunXdxGuAU4.jpg MHLW è il Ministero della Salute, del Lavoro e del Welfare del Giappone. https://stream.mux.com/Y32X7wYem77LDIXvi1Kem7zF5Iym02LBmPunXdxGuAU4.m3u8 https://player.mux.com/Y32X7wYem77LDIXvi1Kem7zF5Iym02LBmPunXdxGuAU4?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FY32X7wYem77LDIXvi1Kem7zF5Iym02LBmPunXdxGuAU4.jpg&accent-color=%232451c6 150 2026-09-11T19:49:59.413Z 2026-09-11 https://www.pureglobal.com/it/glossary/japan-pmda Giappone PMDA: iter e tempi di esame https://www.pureglobal.com/assets/video-posters/dKRTxxT02r8v9kMX6ns5rG3dmEE9ap73mU5cX36R25Hw.jpg Videoguida a PMDA del Giappone: classi di dispositivi, notifica, certificazione, approvazione ministeriale e tempistiche di valutazione. https://stream.mux.com/dKRTxxT02r8v9kMX6ns5rG3dmEE9ap73mU5cX36R25Hw.m3u8 https://player.mux.com/dKRTxxT02r8v9kMX6ns5rG3dmEE9ap73mU5cX36R25Hw?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FdKRTxxT02r8v9kMX6ns5rG3dmEE9ap73mU5cX36R25Hw.jpg&accent-color=%232451c6 103 2026-10-16T04:56:46.728Z 2026-07-24 https://www.pureglobal.com/it/glossary/laboratory-developed-test-ldt 2026-08-11 https://www.pureglobal.com/it/glossary/macau-isaf 2026-07-24 https://www.pureglobal.com/it/glossary/malaysia-mda Malaysia MDA: regolamentazione dispositivi medici https://www.pureglobal.com/assets/video-posters/11KfReMlINv12OFt8uFn4qlyx300rCqE02ukcSqql4XFI.jpg Panoramica sulla Medical Device Authority della Malesia, registrazione dei dispositivi, rappresentanza locale e tariffe per la Classe A. https://stream.mux.com/11KfReMlINv12OFt8uFn4qlyx300rCqE02ukcSqql4XFI.m3u8 https://player.mux.com/11KfReMlINv12OFt8uFn4qlyx300rCqE02ukcSqql4XFI?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F11KfReMlINv12OFt8uFn4qlyx300rCqE02ukcSqql4XFI.jpg&accent-color=%232451c6 110 2026-10-16T04:56:46.830Z 2026-07-24 https://www.pureglobal.com/it/glossary/maude-database 2026-08-11 https://www.pureglobal.com/it/glossary/mdall 2026-08-11 https://www.pureglobal.com/it/glossary/mdsap 2026-07-27 https://www.pureglobal.com/it/glossary/medical-device-classification 2026-07-27 https://www.pureglobal.com/it/glossary/medical-device-reporting-mdr 2026-08-11 https://www.pureglobal.com/it/glossary/medical-device-technical-file 2026-07-27 https://www.pureglobal.com/it/glossary/medsafe 2026-07-24 https://www.pureglobal.com/it/glossary/medwatch 2026-08-11 https://www.pureglobal.com/it/glossary/mexico-general-health-law La Legge Generale sulla Salute del Messico, spiegata https://www.pureglobal.com/assets/video-posters/fLXlzcQ48Xjw1602gOcGgni5IAlPHuez01IX01GyA019pm8.jpg Un'introduzione pratica per i team di dispositivi medici: quadro normativo, ruolo di COFEPRIS e tre verifiche prima di pianificare una sottomissione. https://stream.mux.com/fLXlzcQ48Xjw1602gOcGgni5IAlPHuez01IX01GyA019pm8.m3u8 https://player.mux.com/fLXlzcQ48Xjw1602gOcGgni5IAlPHuez01IX01GyA019pm8?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FfLXlzcQ48Xjw1602gOcGgni5IAlPHuez01IX01GyA019pm8.jpg&accent-color=%232451c6 121 2026-09-11T05:30:50.443Z 2026-09-11 https://www.pureglobal.com/it/glossary/mhra MHRA: norme UK sui dispositivi medici https://www.pureglobal.com/assets/video-posters/PiCcyO02oZcLiqy7n3tHnXD2lZRah9m01cMKWrB67HxIY.jpg Guida su MHRA, normativa UK sui dispositivi medici e percorsi di marcatura CE e UKCA illustrati in questo video. https://stream.mux.com/PiCcyO02oZcLiqy7n3tHnXD2lZRah9m01cMKWrB67HxIY.m3u8 https://player.mux.com/PiCcyO02oZcLiqy7n3tHnXD2lZRah9m01cMKWrB67HxIY?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FPiCcyO02oZcLiqy7n3tHnXD2lZRah9m01cMKWrB67HxIY.jpg&accent-color=%232451c6 107 2026-10-16T04:57:38.088Z 2026-07-24 https://www.pureglobal.com/it/glossary/notified-body 2026-08-11 https://www.pureglobal.com/it/glossary/pakistan-drap 2026-07-24 https://www.pureglobal.com/it/glossary/periodic-safety-update-report-psur 2026-07-27 https://www.pureglobal.com/it/glossary/peru-digemid 2026-07-24 https://www.pureglobal.com/it/glossary/philippines-fda 2026-07-24 https://www.pureglobal.com/it/glossary/post-market-surveillance-pms 2026-08-11 https://www.pureglobal.com/it/glossary/predicate-device 2026-08-11 https://www.pureglobal.com/it/glossary/premarket-approval-pma 2026-08-11 https://www.pureglobal.com/it/glossary/qmsr 2026-07-24 https://www.pureglobal.com/it/glossary/quality-management-system-qms 2026-08-11 https://www.pureglobal.com/it/glossary/rdc-751-2022 Brasile RDC 751: classificazione, dossier ed etichettatura https://www.pureglobal.com/assets/video-posters/DfHGhrX4qz3B68TmGwh6gRsh3sJkJWbJC5VdxPwYtGk.jpg La risoluzione è entrata in vigore a marzo duemilaventitré. https://stream.mux.com/DfHGhrX4qz3B68TmGwh6gRsh3sJkJWbJC5VdxPwYtGk.m3u8 https://player.mux.com/DfHGhrX4qz3B68TmGwh6gRsh3sJkJWbJC5VdxPwYtGk?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FDfHGhrX4qz3B68TmGwh6gRsh3sJkJWbJC5VdxPwYtGk.jpg&accent-color=%232451c6 143 2026-09-11T20:04:40.430Z 2026-09-11 https://www.pureglobal.com/it/glossary/rdc-830-2023 2026-07-27 https://www.pureglobal.com/it/glossary/saudi-sfda SFDA saudita: autorizzazione dei dispositivi e ruoli locali https://www.pureglobal.com/assets/video-posters/8mbmn9uRgYnA78wo26VeXYUJTThq59EzgHJBT5Ww6P8.jpg La Saudi Food and Drug Authority regolamenta i dispositivi medici e i diagnostici in vitro. https://stream.mux.com/8mbmn9uRgYnA78wo26VeXYUJTThq59EzgHJBT5Ww6P8.m3u8 https://player.mux.com/8mbmn9uRgYnA78wo26VeXYUJTThq59EzgHJBT5Ww6P8?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F8mbmn9uRgYnA78wo26VeXYUJTThq59EzgHJBT5Ww6P8.jpg&accent-color=%232451c6 142 2026-09-11T20:02:31.146Z 2026-09-11 https://www.pureglobal.com/it/glossary/singapore-hsa Singapore HSA: scegliere il percorso del dispositivo https://www.pureglobal.com/assets/video-posters/X8PjfkI02Vu1O02z00s00k8BePUW3sZORY6larCHQMXRob4.jpg HSA è la Health Sciences Authority di Singapore. https://stream.mux.com/X8PjfkI02Vu1O02z00s00k8BePUW3sZORY6larCHQMXRob4.m3u8 https://player.mux.com/X8PjfkI02Vu1O02z00s00k8BePUW3sZORY6larCHQMXRob4?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FX8PjfkI02Vu1O02z00s00k8BePUW3sZORY6larCHQMXRob4.jpg&accent-color=%232451c6 144 2026-09-11T20:00:21.669Z 2026-09-11 https://www.pureglobal.com/it/glossary/south-korea-mfds 2026-07-24 https://www.pureglobal.com/it/glossary/swissmedic 2026-07-24 https://www.pureglobal.com/it/glossary/taiwan-tfda 2026-07-24 https://www.pureglobal.com/it/glossary/thailand-fda FDA thailandese: checklist pratica per dispositivi https://www.pureglobal.com/assets/video-posters/msvifwuL00MrUpj47iMzfkIRWkfsdy2VkF2D1AU02YKXI.jpg L'FDA thailandese regolamenta i prodotti sanitari sotto l'egida del Ministero della Sanità Pubblica. https://stream.mux.com/msvifwuL00MrUpj47iMzfkIRWkfsdy2VkF2D1AU02YKXI.m3u8 https://player.mux.com/msvifwuL00MrUpj47iMzfkIRWkfsdy2VkF2D1AU02YKXI?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FmsvifwuL00MrUpj47iMzfkIRWkfsdy2VkF2D1AU02YKXI.jpg&accent-color=%232451c6 138 2026-09-11T19:52:02.030Z 2026-09-11 https://www.pureglobal.com/it/glossary/uae-ede 2026-07-24 https://www.pureglobal.com/it/glossary/ukca-marking 2026-08-11 https://www.pureglobal.com/it/glossary/unique-device-identification-udi 2026-07-27 https://www.pureglobal.com/it/glossary/us-fda US FDA: norme sui dispositivi medici https://www.pureglobal.com/assets/video-posters/J7lElt7fst3xxIh2KjnM81YMqzOVealMu7YBI5ypv1c.jpg Introduzione a FDA e CDRH, classi di rischio dei dispositivi medici, percorsi di sottomissione e tariffe per gli utenti. https://stream.mux.com/J7lElt7fst3xxIh2KjnM81YMqzOVealMu7YBI5ypv1c.m3u8 https://player.mux.com/J7lElt7fst3xxIh2KjnM81YMqzOVealMu7YBI5ypv1c?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FJ7lElt7fst3xxIh2KjnM81YMqzOVealMu7YBI5ypv1c.jpg&accent-color=%232451c6 118 2026-10-16T04:57:21.163Z 2026-07-24 https://www.pureglobal.com/it/glossary/vietnam-moh 2026-07-24 https://www.pureglobal.com/it/glossary/what-is-eudamed 2026-07-24 https://www.pureglobal.com/it/glossary/what-is-swissdamed 2026-10-15 https://www.pureglobal.com/it/glossary/what-is-the-artg Australia ARTG: sponsor e tariffe TGA https://www.pureglobal.com/assets/video-posters/ctdHI00Tr9g6pU1RmSJtpiyysaG7vvsZeEA02y01TOsHhg.jpg Scopri cosa copre l'ARTG australiano e come si collegano sponsor, registrazione dei dispositivi e tariffe TGA. https://stream.mux.com/ctdHI00Tr9g6pU1RmSJtpiyysaG7vvsZeEA02y01TOsHhg.m3u8 https://player.mux.com/ctdHI00Tr9g6pU1RmSJtpiyysaG7vvsZeEA02y01TOsHhg?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FctdHI00Tr9g6pU1RmSJtpiyysaG7vvsZeEA02y01TOsHhg.jpg&accent-color=%232451c6 115 2026-10-16T04:57:03.866Z 2026-07-24 https://www.pureglobal.com/it/glossary/what-is-the-therapeutic-goods-act-1989-australia 2026-07-27 https://www.pureglobal.com/ja/glossary/anatel ブラジルANATEL：取得の要否 https://www.pureglobal.com/assets/video-posters/2kjDRrmC01o02EgPyoQIq01AWl3wjZamMzEKd00cpxiM8UY.jpg ブラジルにおいて通信機能付き医療機器にANATELの無線認証が必要となる要件と、その手続きについて解説します。 https://stream.mux.com/2kjDRrmC01o02EgPyoQIq01AWl3wjZamMzEKd00cpxiM8UY.m3u8 https://player.mux.com/2kjDRrmC01o02EgPyoQIq01AWl3wjZamMzEKd00cpxiM8UY?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F2kjDRrmC01o02EgPyoQIq01AWl3wjZamMzEKd00cpxiM8UY.jpg&accent-color=%232451c6 107 2026-10-16T04:57:36.091Z 2026-07-27 https://www.pureglobal.com/ja/glossary/anmat 2026-07-24 https://www.pureglobal.com/ja/glossary/anvisa ANVISA：ブラジル医療機器チーム向け要点 https://www.pureglobal.com/assets/video-posters/H3qjMY3NvVqnUOxNEl01ftNwrXmOU8vzQA00ydLfxI9pU.jpg ANVISAはブラジルの国家衛生監督庁です。 https://stream.mux.com/H3qjMY3NvVqnUOxNEl01ftNwrXmOU8vzQA00ydLfxI9pU.m3u8 https://player.mux.com/H3qjMY3NvVqnUOxNEl01ftNwrXmOU8vzQA00ydLfxI9pU?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FH3qjMY3NvVqnUOxNEl01ftNwrXmOU8vzQA00ydLfxI9pU.jpg&accent-color=%232451c6 140 2026-09-11T19:46:49.915Z 2026-09-11 https://www.pureglobal.com/ja/glossary/asean-csdt 2026-07-27 https://www.pureglobal.com/ja/glossary/asean-medical-device-directive-amdd 2026-07-27 https://www.pureglobal.com/ja/glossary/australia-tga 2026-07-24 https://www.pureglobal.com/ja/glossary/bangladesh-dgda 2026-07-24 https://www.pureglobal.com/ja/glossary/breakthrough-devices-program 2026-08-11 https://www.pureglobal.com/ja/glossary/ce-marking 2026-08-11 https://www.pureglobal.com/ja/glossary/certificate-of-free-sale 2026-07-27 https://www.pureglobal.com/ja/glossary/china-nmpa 2026-07-24 https://www.pureglobal.com/ja/glossary/clia-waiver 2026-08-11 https://www.pureglobal.com/ja/glossary/cofepris COFEPRIS：メキシコ医療機器チームの確認事項 https://www.pureglobal.com/assets/video-posters/TW2aIxG01u9oMbC2PNK7UzunuX3NFCEh8PPlU4mWgnuE.jpg COFEPRISは、保健省傘下にあるメキシコの連邦衛生リスク保護規制当局です。 https://stream.mux.com/TW2aIxG01u9oMbC2PNK7UzunuX3NFCEh8PPlU4mWgnuE.m3u8 https://player.mux.com/TW2aIxG01u9oMbC2PNK7UzunuX3NFCEh8PPlU4mWgnuE?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FTW2aIxG01u9oMbC2PNK7UzunuX3NFCEh8PPlU4mWgnuE.jpg&accent-color=%232451c6 137 2026-09-11T19:52:54.452Z 2026-09-11 https://www.pureglobal.com/ja/glossary/combination-product 2026-08-11 https://www.pureglobal.com/ja/glossary/companion-diagnostics 2026-08-11 https://www.pureglobal.com/ja/glossary/conformity-assessment 2026-07-27 https://www.pureglobal.com/ja/glossary/corrective-and-preventive-action-capa 2026-08-11 https://www.pureglobal.com/ja/glossary/costa-rica-ministry-of-health 2026-07-24 https://www.pureglobal.com/ja/glossary/current-good-manufacturing-practice-cgmp 2026-08-11 https://www.pureglobal.com/ja/glossary/de-novo-classification 2026-08-11 https://www.pureglobal.com/ja/glossary/decree-3770-of-2004 2026-07-27 https://www.pureglobal.com/ja/glossary/decree-4725-2005 コロンビア政令4725号：医療機器要件の整理 https://www.pureglobal.com/assets/video-posters/fDFAZOjp7pc0202EOB5chRGu02rtVfufvTX024vGOVlvJOA.jpg 2005年に制定された本政令は、コロンビアにおける人用の医療機器を統轄しています。 https://stream.mux.com/fDFAZOjp7pc0202EOB5chRGu02rtVfufvTX024vGOVlvJOA.m3u8 https://player.mux.com/fDFAZOjp7pc0202EOB5chRGu02rtVfufvTX024vGOVlvJOA?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FfDFAZOjp7pc0202EOB5chRGu02rtVfufvTX024vGOVlvJOA.jpg&accent-color=%232451c6 149 2026-09-11T19:57:03.573Z 2026-09-11 https://www.pureglobal.com/ja/glossary/design-controls 2026-08-11 https://www.pureglobal.com/ja/glossary/design-history-file-dhf 2026-08-11 https://www.pureglobal.com/ja/glossary/egypt-eda 2026-07-24 https://www.pureglobal.com/ja/glossary/electronic-instructions-for-use-eifu 2026-08-11 https://www.pureglobal.com/ja/glossary/eu-declaration-of-conformity 2026-07-27 https://www.pureglobal.com/ja/glossary/eu-mdcg MDCG：EU医療機器ガイダンス https://www.pureglobal.com/assets/video-posters/vFXhHIvNgSwdjUa7Pv00wjCvN514HND1ata2JxDqcm900.jpg 欧州医療機器調整グループ（MDCG）の役割と、そのガイダンスがMDRおよびIVDRの円滑な移行・適用をいかに支援するかを解説します。 https://stream.mux.com/vFXhHIvNgSwdjUa7Pv00wjCvN514HND1ata2JxDqcm900.m3u8 https://player.mux.com/vFXhHIvNgSwdjUa7Pv00wjCvN514HND1ata2JxDqcm900?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FvFXhHIvNgSwdjUa7Pv00wjCvN514HND1ata2JxDqcm900.jpg&accent-color=%232451c6 109 2026-10-16T04:58:05.790Z 2026-07-27 https://www.pureglobal.com/ja/glossary/eu-mdr 2026-08-11 https://www.pureglobal.com/ja/glossary/european-commission 2026-07-24 https://www.pureglobal.com/ja/glossary/fda-21-cfr-part-11 2026-08-11 https://www.pureglobal.com/ja/glossary/fda-510k-premarket-notification 2026-08-11 https://www.pureglobal.com/ja/glossary/fda-form-483 2026-08-11 https://www.pureglobal.com/ja/glossary/fda-product-code 2026-08-11 https://www.pureglobal.com/ja/glossary/fda-recall-classes 2026-08-11 https://www.pureglobal.com/ja/glossary/fda-warning-letter 2026-08-11 https://www.pureglobal.com/ja/glossary/field-safety-corrective-action-fsca 2026-07-27 https://www.pureglobal.com/ja/glossary/general-safety-and-performance-requirements-gspr 2026-07-27 https://www.pureglobal.com/ja/glossary/gmdn 2026-07-27 https://www.pureglobal.com/ja/glossary/gudid 2026-08-11 https://www.pureglobal.com/ja/glossary/health-canada-hc カナダ保健省：MDELとMDLの解説 https://www.pureglobal.com/assets/video-posters/Elr3pp02daZ3cHrUOfyy5s2nYlMc00xm9IywdsJB1pc8A.jpg 本動画で取り上げるMDELとMDL、カナダの医療機器クラス分類、およびライセンス申請手数料について解説します。 https://stream.mux.com/Elr3pp02daZ3cHrUOfyy5s2nYlMc00xm9IywdsJB1pc8A.m3u8 https://player.mux.com/Elr3pp02daZ3cHrUOfyy5s2nYlMc00xm9IywdsJB1pc8A?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FElr3pp02daZ3cHrUOfyy5s2nYlMc00xm9IywdsJB1pc8A.jpg&accent-color=%232451c6 111 2026-10-16T04:57:20.641Z 2026-07-24 https://www.pureglobal.com/ja/glossary/hong-kong-mdd 2026-07-24 https://www.pureglobal.com/ja/glossary/iec-60601-1 2026-07-27 https://www.pureglobal.com/ja/glossary/iec-60601-1-2 2026-08-11 https://www.pureglobal.com/ja/glossary/iec-62304 2026-07-27 https://www.pureglobal.com/ja/glossary/iec-62366-1 2026-07-27 https://www.pureglobal.com/ja/glossary/iec-81001-5-1 2026-07-27 https://www.pureglobal.com/ja/glossary/imda ベトナムIMDA：医療機器クラスと登録 https://www.pureglobal.com/assets/video-posters/ZeTHNh2Kol01XXJq1OHedf7LxxsqvCMugJssLn2Q1Vr4.jpg ベトナムIMDAの概要、医療機器クラスA〜Dの分類、登録申請ルート、および手数料について解説します。 https://stream.mux.com/ZeTHNh2Kol01XXJq1OHedf7LxxsqvCMugJssLn2Q1Vr4.m3u8 https://player.mux.com/ZeTHNh2Kol01XXJq1OHedf7LxxsqvCMugJssLn2Q1Vr4?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FZeTHNh2Kol01XXJq1OHedf7LxxsqvCMugJssLn2Q1Vr4.jpg&accent-color=%232451c6 107 2026-10-16T04:57:54.771Z 2026-07-24 https://www.pureglobal.com/ja/glossary/imdrf 2026-07-27 https://www.pureglobal.com/ja/glossary/india-cdsco 2026-07-24 https://www.pureglobal.com/ja/glossary/indonesia-moh 2026-07-27 https://www.pureglobal.com/ja/glossary/inmetro 2026-07-27 https://www.pureglobal.com/ja/glossary/investigational-device-exemption-ide FDA IDE：治験機器適用免除 https://www.pureglobal.com/assets/video-posters/6VHfOLqokbmjvm0157534U1CEumk4LhdnLXa00ZB87XJI.jpg 治験機器適用免除（IDE）が機器の臨床試験、リスク判定、およびFDAの承認にどのように適用されるかを解説します。 https://stream.mux.com/6VHfOLqokbmjvm0157534U1CEumk4LhdnLXa00ZB87XJI.m3u8 https://player.mux.com/6VHfOLqokbmjvm0157534U1CEumk4LhdnLXa00ZB87XJI?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F6VHfOLqokbmjvm0157534U1CEumk4LhdnLXa00ZB87XJI.jpg&accent-color=%232451c6 107 2026-10-16T04:58:22.372Z 2026-08-11 https://www.pureglobal.com/ja/glossary/invima INVIMA：コロンビア医療機器ロードマップ https://www.pureglobal.com/assets/video-posters/ab401QJq02YlJlFdlE5LcTKcnh029hRkL6PP1jQVQKY5hQ.jpg INVIMAは、コロンビアの国家保健製品規制当局です。 https://stream.mux.com/ab401QJq02YlJlFdlE5LcTKcnh029hRkL6PP1jQVQKY5hQ.m3u8 https://player.mux.com/ab401QJq02YlJlFdlE5LcTKcnh029hRkL6PP1jQVQKY5hQ?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2Fab401QJq02YlJlFdlE5LcTKcnh029hRkL6PP1jQVQKY5hQ.jpg&accent-color=%232451c6 145 2026-09-11T19:44:49.352Z 2026-09-11 https://www.pureglobal.com/ja/glossary/iso-10993 2026-07-27 https://www.pureglobal.com/ja/glossary/iso-11135 2026-07-27 https://www.pureglobal.com/ja/glossary/iso-11137 2026-07-27 https://www.pureglobal.com/ja/glossary/iso-11607 2026-07-27 https://www.pureglobal.com/ja/glossary/iso-13485 2026-07-27 https://www.pureglobal.com/ja/glossary/iso-14155 2026-07-27 https://www.pureglobal.com/ja/glossary/iso-14644 2026-08-11 https://www.pureglobal.com/ja/glossary/iso-14971 2026-07-27 https://www.pureglobal.com/ja/glossary/iso-15223-1 ISO 15223-1：医療機器ラベルに記載すべき事項 https://www.pureglobal.com/assets/video-posters/j1iAp6u56Tv1jeYz01tC7e02O9OFD4oLKnd3QmazHD63M.jpg 本規格は、医療機器とともに提供される情報に用いる図記号を規定しています。 https://stream.mux.com/j1iAp6u56Tv1jeYz01tC7e02O9OFD4oLKnd3QmazHD63M.m3u8 https://player.mux.com/j1iAp6u56Tv1jeYz01tC7e02O9OFD4oLKnd3QmazHD63M?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2Fj1iAp6u56Tv1jeYz01tC7e02O9OFD4oLKnd3QmazHD63M.jpg&accent-color=%232451c6 150 2026-09-11T19:54:56.870Z 2026-09-11 https://www.pureglobal.com/ja/glossary/iso-17665 2026-07-27 https://www.pureglobal.com/ja/glossary/iso-20417 2026-07-27 https://www.pureglobal.com/ja/glossary/israel-amar 2026-07-24 https://www.pureglobal.com/ja/glossary/japan-mhlw MHLWとPMDAの役割分担 https://www.pureglobal.com/assets/video-posters/fmM28RUH6H0202zWE4EqAZpFoDmLHxKZzKHrul8tJ1J8A.jpg MHLWは日本の厚生労働省であり、医療機器承認の行政権限を有しています。 https://stream.mux.com/fmM28RUH6H0202zWE4EqAZpFoDmLHxKZzKHrul8tJ1J8A.m3u8 https://player.mux.com/fmM28RUH6H0202zWE4EqAZpFoDmLHxKZzKHrul8tJ1J8A?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FfmM28RUH6H0202zWE4EqAZpFoDmLHxKZzKHrul8tJ1J8A.jpg&accent-color=%232451c6 148 2026-09-11T19:48:51.626Z 2026-09-11 https://www.pureglobal.com/ja/glossary/japan-pmda 日本のPMDA：申請ルートと審査期間 https://www.pureglobal.com/assets/video-posters/dKRTxxT02r8v9kMX6ns5rG3dmEE9ap73mU5cX36R25Hw.jpg 日本のPMDA、医療機器クラス分類、届出、認証、大臣承認、および審査期間について解説する動画ガイドです。 https://stream.mux.com/dKRTxxT02r8v9kMX6ns5rG3dmEE9ap73mU5cX36R25Hw.m3u8 https://player.mux.com/dKRTxxT02r8v9kMX6ns5rG3dmEE9ap73mU5cX36R25Hw?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FdKRTxxT02r8v9kMX6ns5rG3dmEE9ap73mU5cX36R25Hw.jpg&accent-color=%232451c6 103 2026-10-16T04:56:46.728Z 2026-07-24 https://www.pureglobal.com/ja/glossary/laboratory-developed-test-ldt 2026-08-11 https://www.pureglobal.com/ja/glossary/macau-isaf 2026-07-24 https://www.pureglobal.com/ja/glossary/malaysia-mda マレーシアMDA：医療機器規制 https://www.pureglobal.com/assets/video-posters/11KfReMlINv12OFt8uFn4qlyx300rCqE02ukcSqql4XFI.jpg マレーシア医療機器庁（MDA）、機器登録、現地代理人、およびクラスAの手数料の概要を解説します。 https://stream.mux.com/11KfReMlINv12OFt8uFn4qlyx300rCqE02ukcSqql4XFI.m3u8 https://player.mux.com/11KfReMlINv12OFt8uFn4qlyx300rCqE02ukcSqql4XFI?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F11KfReMlINv12OFt8uFn4qlyx300rCqE02ukcSqql4XFI.jpg&accent-color=%232451c6 110 2026-10-16T04:56:46.830Z 2026-07-24 https://www.pureglobal.com/ja/glossary/maude-database 2026-08-11 https://www.pureglobal.com/ja/glossary/mdall 2026-08-11 https://www.pureglobal.com/ja/glossary/mdsap 2026-07-27 https://www.pureglobal.com/ja/glossary/medical-device-classification 2026-07-27 https://www.pureglobal.com/ja/glossary/medical-device-reporting-mdr 2026-08-11 https://www.pureglobal.com/ja/glossary/medical-device-technical-file 2026-07-27 https://www.pureglobal.com/ja/glossary/medsafe 2026-07-24 https://www.pureglobal.com/ja/glossary/medwatch 2026-08-11 https://www.pureglobal.com/ja/glossary/mexico-general-health-law メキシコ一般保健法の解説 https://www.pureglobal.com/assets/video-posters/5z2PNdrQFRpMx65GOjNCyc3TaYa101lEUa2iIWD00eeRY.jpg 医療機器チーム向けの実践的な入門ガイドです。法的枠組み、COFEPRISの役割、および申請計画の前に確認すべき3つのチェック項目について解説します。 https://stream.mux.com/5z2PNdrQFRpMx65GOjNCyc3TaYa101lEUa2iIWD00eeRY.m3u8 https://player.mux.com/5z2PNdrQFRpMx65GOjNCyc3TaYa101lEUa2iIWD00eeRY?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F5z2PNdrQFRpMx65GOjNCyc3TaYa101lEUa2iIWD00eeRY.jpg&accent-color=%232451c6 127 2026-09-11T05:25:28.881Z 2026-09-11 https://www.pureglobal.com/ja/glossary/mhra MHRA：英国の医療機器規制 https://www.pureglobal.com/assets/video-posters/PiCcyO02oZcLiqy7n3tHnXD2lZRah9m01cMKWrB67HxIY.jpg 本動画で取り上げるMHRA、英国の医療機器規制、ならびにCEおよびUKCAマーキングの認証ルートに関するガイドです。 https://stream.mux.com/PiCcyO02oZcLiqy7n3tHnXD2lZRah9m01cMKWrB67HxIY.m3u8 https://player.mux.com/PiCcyO02oZcLiqy7n3tHnXD2lZRah9m01cMKWrB67HxIY?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FPiCcyO02oZcLiqy7n3tHnXD2lZRah9m01cMKWrB67HxIY.jpg&accent-color=%232451c6 107 2026-10-16T04:57:38.088Z 2026-07-24 https://www.pureglobal.com/ja/glossary/notified-body 2026-08-11 https://www.pureglobal.com/ja/glossary/pakistan-drap 2026-07-24 https://www.pureglobal.com/ja/glossary/periodic-safety-update-report-psur 2026-07-27 https://www.pureglobal.com/ja/glossary/peru-digemid 2026-07-24 https://www.pureglobal.com/ja/glossary/philippines-fda 2026-07-24 https://www.pureglobal.com/ja/glossary/post-market-surveillance-pms 2026-08-11 https://www.pureglobal.com/ja/glossary/predicate-device 2026-08-11 https://www.pureglobal.com/ja/glossary/premarket-approval-pma 2026-08-11 https://www.pureglobal.com/ja/glossary/qmsr 2026-07-24 https://www.pureglobal.com/ja/glossary/quality-management-system-qms 2026-08-11 https://www.pureglobal.com/ja/glossary/rdc-751-2022 ブラジルRDC 751：クラス分類・申請資料・表示 https://www.pureglobal.com/assets/video-posters/RfAoTBOvMk901yqN2pM2Fk9bRJu7gP802PYLsC602aJgM4.jpg 本決議は2023年3月に施行されました。 https://stream.mux.com/RfAoTBOvMk901yqN2pM2Fk9bRJu7gP802PYLsC602aJgM4.m3u8 https://player.mux.com/RfAoTBOvMk901yqN2pM2Fk9bRJu7gP802PYLsC602aJgM4?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FRfAoTBOvMk901yqN2pM2Fk9bRJu7gP802PYLsC602aJgM4.jpg&accent-color=%232451c6 156 2026-09-11T20:03:27.480Z 2026-09-11 https://www.pureglobal.com/ja/glossary/rdc-830-2023 2026-07-27 https://www.pureglobal.com/ja/glossary/saudi-sfda サウジSFDA：医療機器承認と現地での役割 https://www.pureglobal.com/assets/video-posters/P0000F5kOu3i00XwZdJL6BZVMYthBGCS5lf6Tw9uWPQO6s.jpg サウジ食品医薬品庁（SFDA）は、医療機器および体外診断用医薬品を規制しています。 https://stream.mux.com/P0000F5kOu3i00XwZdJL6BZVMYthBGCS5lf6Tw9uWPQO6s.m3u8 https://player.mux.com/P0000F5kOu3i00XwZdJL6BZVMYthBGCS5lf6Tw9uWPQO6s?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FP0000F5kOu3i00XwZdJL6BZVMYthBGCS5lf6Tw9uWPQO6s.jpg&accent-color=%232451c6 152 2026-09-11T20:01:18.113Z 2026-09-11 https://www.pureglobal.com/ja/glossary/singapore-hsa シンガポールHSA：医療機器申請ルートの選定 https://www.pureglobal.com/assets/video-posters/W401cjusjEBc1AGpBD32ULeSsQG00kYu9gv8yV2xcFfiY.jpg HSAはシンガポールの保健科学庁（HSA）です。 https://stream.mux.com/W401cjusjEBc1AGpBD32ULeSsQG00kYu9gv8yV2xcFfiY.m3u8 https://player.mux.com/W401cjusjEBc1AGpBD32ULeSsQG00kYu9gv8yV2xcFfiY?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FW401cjusjEBc1AGpBD32ULeSsQG00kYu9gv8yV2xcFfiY.jpg&accent-color=%232451c6 151 2026-09-11T19:59:17.484Z 2026-09-11 https://www.pureglobal.com/ja/glossary/south-korea-mfds 2026-07-24 https://www.pureglobal.com/ja/glossary/swissmedic 2026-07-24 https://www.pureglobal.com/ja/glossary/taiwan-tfda 2026-07-24 https://www.pureglobal.com/ja/glossary/thailand-fda タイFDA：医療機器上市の実務チェックリスト https://www.pureglobal.com/assets/video-posters/2OAfKtuS2OCt019nLxX6UkEv6a2dEWLCty5UspYnsA5w.jpg タイFDAは、公衆衛生省のもとで健康関連製品を規制しています。 https://stream.mux.com/2OAfKtuS2OCt019nLxX6UkEv6a2dEWLCty5UspYnsA5w.m3u8 https://player.mux.com/2OAfKtuS2OCt019nLxX6UkEv6a2dEWLCty5UspYnsA5w?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F2OAfKtuS2OCt019nLxX6UkEv6a2dEWLCty5UspYnsA5w.jpg&accent-color=%232451c6 141 2026-09-11T19:50:54.804Z 2026-09-11 https://www.pureglobal.com/ja/glossary/uae-ede 2026-07-24 https://www.pureglobal.com/ja/glossary/ukca-marking 2026-08-11 https://www.pureglobal.com/ja/glossary/unique-device-identification-udi 2026-07-27 https://www.pureglobal.com/ja/glossary/us-fda 米国FDA：医療機器規制 https://www.pureglobal.com/assets/video-posters/J7lElt7fst3xxIh2KjnM81YMqzOVealMu7YBI5ypv1c.jpg FDAおよびCDRH、医療機器のリスク分類、申請ルート、ならびに審査手数料（ユーザーフィー）の概要を解説します。 https://stream.mux.com/J7lElt7fst3xxIh2KjnM81YMqzOVealMu7YBI5ypv1c.m3u8 https://player.mux.com/J7lElt7fst3xxIh2KjnM81YMqzOVealMu7YBI5ypv1c?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FJ7lElt7fst3xxIh2KjnM81YMqzOVealMu7YBI5ypv1c.jpg&accent-color=%232451c6 118 2026-10-16T04:57:21.163Z 2026-07-24 https://www.pureglobal.com/ja/glossary/vietnam-moh 2026-07-24 https://www.pureglobal.com/ja/glossary/what-is-eudamed 2026-07-24 https://www.pureglobal.com/ja/glossary/what-is-swissdamed 2026-10-15 https://www.pureglobal.com/ja/glossary/what-is-the-artg 豪州ARTG：スポンサーとTGA手数料 https://www.pureglobal.com/assets/video-posters/ctdHI00Tr9g6pU1RmSJtpiyysaG7vvsZeEA02y01TOsHhg.jpg オーストラリアARTGの対象範囲、ならびに医療機器スポンサー、登録、およびTGA手数料の相互関係について解説します。 https://stream.mux.com/ctdHI00Tr9g6pU1RmSJtpiyysaG7vvsZeEA02y01TOsHhg.m3u8 https://player.mux.com/ctdHI00Tr9g6pU1RmSJtpiyysaG7vvsZeEA02y01TOsHhg?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FctdHI00Tr9g6pU1RmSJtpiyysaG7vvsZeEA02y01TOsHhg.jpg&accent-color=%232451c6 115 2026-10-16T04:57:03.866Z 2026-07-24 https://www.pureglobal.com/ja/glossary/what-is-the-therapeutic-goods-act-1989-australia 2026-07-27 https://www.pureglobal.com/ko/glossary/anatel 브라질 ANATEL: 기기에 필요합니까? https://www.pureglobal.com/assets/video-posters/2kjDRrmC01o02EgPyoQIq01AWl3wjZamMzEKd00cpxiM8UY.jpg 브라질에서 연결형 의료기기에 ANATEL 무선 형식승인이 필요한 경우와 해당 절차에 대해 알아봅니다. https://stream.mux.com/2kjDRrmC01o02EgPyoQIq01AWl3wjZamMzEKd00cpxiM8UY.m3u8 https://player.mux.com/2kjDRrmC01o02EgPyoQIq01AWl3wjZamMzEKd00cpxiM8UY?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F2kjDRrmC01o02EgPyoQIq01AWl3wjZamMzEKd00cpxiM8UY.jpg&accent-color=%232451c6 107 2026-10-16T04:57:36.091Z 2026-07-27 https://www.pureglobal.com/ko/glossary/anmat 2026-07-24 https://www.pureglobal.com/ko/glossary/anvisa ANVISA: 브라질 의료기기 팀 필수 숙지사항 https://www.pureglobal.com/assets/video-posters/UxtzcP2fWqE00ulvQSqU76Gm9NPh02ghNCO9dJluxjvKg.jpg 안비사는 브라질의 보건위생 규제기관입니다. https://stream.mux.com/UxtzcP2fWqE00ulvQSqU76Gm9NPh02ghNCO9dJluxjvKg.m3u8 https://player.mux.com/UxtzcP2fWqE00ulvQSqU76Gm9NPh02ghNCO9dJluxjvKg?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FUxtzcP2fWqE00ulvQSqU76Gm9NPh02ghNCO9dJluxjvKg.jpg&accent-color=%232451c6 129 2026-09-11T19:47:03.105Z 2026-09-11 https://www.pureglobal.com/ko/glossary/asean-csdt 2026-07-27 https://www.pureglobal.com/ko/glossary/asean-medical-device-directive-amdd 2026-07-27 https://www.pureglobal.com/ko/glossary/australia-tga 2026-07-24 https://www.pureglobal.com/ko/glossary/bangladesh-dgda 2026-07-24 https://www.pureglobal.com/ko/glossary/breakthrough-devices-program 2026-08-11 https://www.pureglobal.com/ko/glossary/ce-marking 2026-08-11 https://www.pureglobal.com/ko/glossary/certificate-of-free-sale 2026-07-27 https://www.pureglobal.com/ko/glossary/china-nmpa 2026-07-24 https://www.pureglobal.com/ko/glossary/clia-waiver 2026-08-11 https://www.pureglobal.com/ko/glossary/cofepris COFEPRIS: 멕시코 의료기기 팀 확인 사항 https://www.pureglobal.com/assets/video-posters/95n01qf9JZDVNdOC5j02Yo12rfRJlbiZ18gwx02d5AWcOg.jpg COFEPRIS는 멕시코 보건부 산하의 연방 보건위험 규제 기관입니다. https://stream.mux.com/95n01qf9JZDVNdOC5j02Yo12rfRJlbiZ18gwx02d5AWcOg.m3u8 https://player.mux.com/95n01qf9JZDVNdOC5j02Yo12rfRJlbiZ18gwx02d5AWcOg?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F95n01qf9JZDVNdOC5j02Yo12rfRJlbiZ18gwx02d5AWcOg.jpg&accent-color=%232451c6 136 2026-09-11T19:53:08.498Z 2026-09-11 https://www.pureglobal.com/ko/glossary/combination-product 2026-08-11 https://www.pureglobal.com/ko/glossary/companion-diagnostics 2026-08-11 https://www.pureglobal.com/ko/glossary/conformity-assessment 2026-07-27 https://www.pureglobal.com/ko/glossary/corrective-and-preventive-action-capa 2026-08-11 https://www.pureglobal.com/ko/glossary/costa-rica-ministry-of-health 2026-07-24 https://www.pureglobal.com/ko/glossary/current-good-manufacturing-practice-cgmp 2026-08-11 https://www.pureglobal.com/ko/glossary/de-novo-classification 2026-08-11 https://www.pureglobal.com/ko/glossary/decree-3770-of-2004 2026-07-27 https://www.pureglobal.com/ko/glossary/decree-4725-2005 콜롬비아 법령 4725: 의료기기 요건 안내 https://www.pureglobal.com/assets/video-posters/sFv779l21ESmW00WMTRJ4y5oj00zYX59ajIhNoNOLewuw.jpg 2005년에 제정된 이 법령은 콜롬비아에서 인체에 사용되는 의료기기를 규율합니다. https://stream.mux.com/sFv779l21ESmW00WMTRJ4y5oj00zYX59ajIhNoNOLewuw.m3u8 https://player.mux.com/sFv779l21ESmW00WMTRJ4y5oj00zYX59ajIhNoNOLewuw?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FsFv779l21ESmW00WMTRJ4y5oj00zYX59ajIhNoNOLewuw.jpg&accent-color=%232451c6 145 2026-09-11T19:57:17.991Z 2026-09-11 https://www.pureglobal.com/ko/glossary/design-controls 2026-08-11 https://www.pureglobal.com/ko/glossary/design-history-file-dhf 2026-08-11 https://www.pureglobal.com/ko/glossary/egypt-eda 2026-07-24 https://www.pureglobal.com/ko/glossary/electronic-instructions-for-use-eifu 2026-08-11 https://www.pureglobal.com/ko/glossary/eu-declaration-of-conformity 2026-07-27 https://www.pureglobal.com/ko/glossary/eu-mdcg MDCG: EU 의료기기 가이던스 https://www.pureglobal.com/assets/video-posters/vFXhHIvNgSwdjUa7Pv00wjCvN514HND1ata2JxDqcm900.jpg EU 의료기기조정그룹(MDCG)의 역할과 해당 가이던스가 MDR 및 IVDR 이행을 어떻게 지원하는지 알아봅니다. https://stream.mux.com/vFXhHIvNgSwdjUa7Pv00wjCvN514HND1ata2JxDqcm900.m3u8 https://player.mux.com/vFXhHIvNgSwdjUa7Pv00wjCvN514HND1ata2JxDqcm900?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FvFXhHIvNgSwdjUa7Pv00wjCvN514HND1ata2JxDqcm900.jpg&accent-color=%232451c6 109 2026-10-16T04:58:05.790Z 2026-07-27 https://www.pureglobal.com/ko/glossary/eu-mdr 2026-08-11 https://www.pureglobal.com/ko/glossary/european-commission 2026-07-24 https://www.pureglobal.com/ko/glossary/fda-21-cfr-part-11 2026-08-11 https://www.pureglobal.com/ko/glossary/fda-510k-premarket-notification 2026-08-11 https://www.pureglobal.com/ko/glossary/fda-form-483 2026-08-11 https://www.pureglobal.com/ko/glossary/fda-product-code 2026-08-11 https://www.pureglobal.com/ko/glossary/fda-recall-classes 2026-08-11 https://www.pureglobal.com/ko/glossary/fda-warning-letter 2026-08-11 https://www.pureglobal.com/ko/glossary/field-safety-corrective-action-fsca 2026-07-27 https://www.pureglobal.com/ko/glossary/general-safety-and-performance-requirements-gspr 2026-07-27 https://www.pureglobal.com/ko/glossary/gmdn 2026-07-27 https://www.pureglobal.com/ko/glossary/gudid 2026-08-11 https://www.pureglobal.com/ko/glossary/health-canada-hc 캐나다 보건부: MDEL 및 MDL 설명 https://www.pureglobal.com/assets/video-posters/Elr3pp02daZ3cHrUOfyy5s2nYlMc00xm9IywdsJB1pc8A.jpg MDEL 및 MDL, 캐나다의 의료기기 등급과 본 영상에서 다루는 허가 수수료에 대해 알아봅니다. https://stream.mux.com/Elr3pp02daZ3cHrUOfyy5s2nYlMc00xm9IywdsJB1pc8A.m3u8 https://player.mux.com/Elr3pp02daZ3cHrUOfyy5s2nYlMc00xm9IywdsJB1pc8A?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FElr3pp02daZ3cHrUOfyy5s2nYlMc00xm9IywdsJB1pc8A.jpg&accent-color=%232451c6 111 2026-10-16T04:57:20.641Z 2026-07-24 https://www.pureglobal.com/ko/glossary/hong-kong-mdd 2026-07-24 https://www.pureglobal.com/ko/glossary/iec-60601-1 2026-07-27 https://www.pureglobal.com/ko/glossary/iec-60601-1-2 2026-08-11 https://www.pureglobal.com/ko/glossary/iec-62304 2026-07-27 https://www.pureglobal.com/ko/glossary/iec-62366-1 2026-07-27 https://www.pureglobal.com/ko/glossary/iec-81001-5-1 2026-07-27 https://www.pureglobal.com/ko/glossary/imda 베트남 IMDA: 의료기기 등급 및 등록 https://www.pureglobal.com/assets/video-posters/ZeTHNh2Kol01XXJq1OHedf7LxxsqvCMugJssLn2Q1Vr4.jpg 베트남 IMDA에 대해 알아보고 의료기기 A–D 등급, 등록 경로 및 수수료를 살펴봅니다. https://stream.mux.com/ZeTHNh2Kol01XXJq1OHedf7LxxsqvCMugJssLn2Q1Vr4.m3u8 https://player.mux.com/ZeTHNh2Kol01XXJq1OHedf7LxxsqvCMugJssLn2Q1Vr4?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FZeTHNh2Kol01XXJq1OHedf7LxxsqvCMugJssLn2Q1Vr4.jpg&accent-color=%232451c6 107 2026-10-16T04:57:54.771Z 2026-07-24 https://www.pureglobal.com/ko/glossary/imdrf 2026-07-27 https://www.pureglobal.com/ko/glossary/india-cdsco 2026-07-24 https://www.pureglobal.com/ko/glossary/indonesia-moh 2026-07-27 https://www.pureglobal.com/ko/glossary/inmetro 2026-07-27 https://www.pureglobal.com/ko/glossary/investigational-device-exemption-ide FDA IDE: 임상시험용 의료기기 면제 https://www.pureglobal.com/assets/video-posters/6VHfOLqokbmjvm0157534U1CEumk4LhdnLXa00ZB87XJI.jpg 임상시험용 의료기기 면제(IDE)가 의료기기 연구, 위험도 판정 및 FDA 승인에 어떻게 적용되는지 알아봅니다. https://stream.mux.com/6VHfOLqokbmjvm0157534U1CEumk4LhdnLXa00ZB87XJI.m3u8 https://player.mux.com/6VHfOLqokbmjvm0157534U1CEumk4LhdnLXa00ZB87XJI?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F6VHfOLqokbmjvm0157534U1CEumk4LhdnLXa00ZB87XJI.jpg&accent-color=%232451c6 107 2026-10-16T04:58:22.372Z 2026-08-11 https://www.pureglobal.com/ko/glossary/invima INVIMA: 콜롬비아 의료기기 로드맵 https://www.pureglobal.com/assets/video-posters/K02AnAfom2Ix01wjnuKM4N6pVNeuuDNOqFHBQ69tEEzK4.jpg 인비마는 콜롬비아의 국가 보건 제품 규제 기관입니다. https://stream.mux.com/K02AnAfom2Ix01wjnuKM4N6pVNeuuDNOqFHBQ69tEEzK4.m3u8 https://player.mux.com/K02AnAfom2Ix01wjnuKM4N6pVNeuuDNOqFHBQ69tEEzK4?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FK02AnAfom2Ix01wjnuKM4N6pVNeuuDNOqFHBQ69tEEzK4.jpg&accent-color=%232451c6 137 2026-09-11T19:45:02.425Z 2026-09-11 https://www.pureglobal.com/ko/glossary/iso-10993 2026-07-27 https://www.pureglobal.com/ko/glossary/iso-11135 2026-07-27 https://www.pureglobal.com/ko/glossary/iso-11137 2026-07-27 https://www.pureglobal.com/ko/glossary/iso-11607 2026-07-27 https://www.pureglobal.com/ko/glossary/iso-13485 2026-07-27 https://www.pureglobal.com/ko/glossary/iso-14155 2026-07-27 https://www.pureglobal.com/ko/glossary/iso-14644 2026-08-11 https://www.pureglobal.com/ko/glossary/iso-14971 2026-07-27 https://www.pureglobal.com/ko/glossary/iso-15223-1 ISO 15223-1: 의료기기 라벨 표시 사항 https://www.pureglobal.com/assets/video-posters/4Z9k6GC6KIgygo9E402HrUupwQSa015vslEAyWioCIo1c.jpg 해당 표준은 의료기기와 함께 제공되는 정보에 쓰이는 심볼을 규정합니다. https://stream.mux.com/4Z9k6GC6KIgygo9E402HrUupwQSa015vslEAyWioCIo1c.m3u8 https://player.mux.com/4Z9k6GC6KIgygo9E402HrUupwQSa015vslEAyWioCIo1c?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F4Z9k6GC6KIgygo9E402HrUupwQSa015vslEAyWioCIo1c.jpg&accent-color=%232451c6 135 2026-09-11T19:55:10.617Z 2026-09-11 https://www.pureglobal.com/ko/glossary/iso-17665 2026-07-27 https://www.pureglobal.com/ko/glossary/iso-20417 2026-07-27 https://www.pureglobal.com/ko/glossary/israel-amar 2026-07-24 https://www.pureglobal.com/ko/glossary/japan-mhlw 일본 MHLW 및 PMDA: 기관별 역할 https://www.pureglobal.com/assets/video-posters/KeiExqzoxZZbxC01mcfwbd6tQMPClrEw43p6RIeDtFJ00.jpg MHLW는 일본의 후생노동성으로, 의료기기 승인에 대한 행정 권한을 갖습니다. https://stream.mux.com/KeiExqzoxZZbxC01mcfwbd6tQMPClrEw43p6RIeDtFJ00.m3u8 https://player.mux.com/KeiExqzoxZZbxC01mcfwbd6tQMPClrEw43p6RIeDtFJ00?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FKeiExqzoxZZbxC01mcfwbd6tQMPClrEw43p6RIeDtFJ00.jpg&accent-color=%232451c6 135 2026-09-11T19:49:05.152Z 2026-09-11 https://www.pureglobal.com/ko/glossary/japan-pmda 일본 PMDA: 의료기기 경로 및 심사 기간 https://www.pureglobal.com/assets/video-posters/dKRTxxT02r8v9kMX6ns5rG3dmEE9ap73mU5cX36R25Hw.jpg 일본의 PMDA, 의료기기 등급, 신고, 인증, 부처 승인 및 심사 일정을 안내하는 동영상 가이드입니다. https://stream.mux.com/dKRTxxT02r8v9kMX6ns5rG3dmEE9ap73mU5cX36R25Hw.m3u8 https://player.mux.com/dKRTxxT02r8v9kMX6ns5rG3dmEE9ap73mU5cX36R25Hw?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FdKRTxxT02r8v9kMX6ns5rG3dmEE9ap73mU5cX36R25Hw.jpg&accent-color=%232451c6 103 2026-10-16T04:56:46.728Z 2026-07-24 https://www.pureglobal.com/ko/glossary/laboratory-developed-test-ldt 2026-08-11 https://www.pureglobal.com/ko/glossary/macau-isaf 2026-07-24 https://www.pureglobal.com/ko/glossary/malaysia-mda 말레이시아 MDA: 의료기기 규제 https://www.pureglobal.com/assets/video-posters/11KfReMlINv12OFt8uFn4qlyx300rCqE02ukcSqql4XFI.jpg 말레이시아 의료기기청(MDA), 의료기기 등록, 현지 대리인 및 Class A 수수료에 대한 개요를 제공합니다. https://stream.mux.com/11KfReMlINv12OFt8uFn4qlyx300rCqE02ukcSqql4XFI.m3u8 https://player.mux.com/11KfReMlINv12OFt8uFn4qlyx300rCqE02ukcSqql4XFI?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F11KfReMlINv12OFt8uFn4qlyx300rCqE02ukcSqql4XFI.jpg&accent-color=%232451c6 110 2026-10-16T04:56:46.830Z 2026-07-24 https://www.pureglobal.com/ko/glossary/maude-database 2026-08-11 https://www.pureglobal.com/ko/glossary/mdall 2026-08-11 https://www.pureglobal.com/ko/glossary/mdsap 2026-07-27 https://www.pureglobal.com/ko/glossary/medical-device-classification 2026-07-27 https://www.pureglobal.com/ko/glossary/medical-device-reporting-mdr 2026-08-11 https://www.pureglobal.com/ko/glossary/medical-device-technical-file 2026-07-27 https://www.pureglobal.com/ko/glossary/medsafe 2026-07-24 https://www.pureglobal.com/ko/glossary/medwatch 2026-08-11 https://www.pureglobal.com/ko/glossary/mexico-general-health-law 멕시코 일반건강법 해설 https://www.pureglobal.com/assets/video-posters/6KWSpXpWo2eDmtiyFlvQ02Hy5AjoQ02qspWeKlnSyIfxU.jpg 의료기기 팀을 위한 실무 가이드: 법적 체계, COFEPRIS의 역할 및 인허가 신청 계획 전 확인해야 할 세 가지 점검 사항을 안내합니다. https://stream.mux.com/6KWSpXpWo2eDmtiyFlvQ02Hy5AjoQ02qspWeKlnSyIfxU.m3u8 https://player.mux.com/6KWSpXpWo2eDmtiyFlvQ02Hy5AjoQ02qspWeKlnSyIfxU?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F6KWSpXpWo2eDmtiyFlvQ02Hy5AjoQ02qspWeKlnSyIfxU.jpg&accent-color=%232451c6 121 2026-09-11T05:26:48.798Z 2026-09-11 https://www.pureglobal.com/ko/glossary/mhra MHRA: 영국 의료기기 규정 https://www.pureglobal.com/assets/video-posters/PiCcyO02oZcLiqy7n3tHnXD2lZRah9m01cMKWrB67HxIY.jpg 본 영상에서 다루는 MHRA, 영국 의료기기 규제, CE 및 UKCA 마킹 경로에 대한 가이드입니다. https://stream.mux.com/PiCcyO02oZcLiqy7n3tHnXD2lZRah9m01cMKWrB67HxIY.m3u8 https://player.mux.com/PiCcyO02oZcLiqy7n3tHnXD2lZRah9m01cMKWrB67HxIY?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FPiCcyO02oZcLiqy7n3tHnXD2lZRah9m01cMKWrB67HxIY.jpg&accent-color=%232451c6 107 2026-10-16T04:57:38.088Z 2026-07-24 https://www.pureglobal.com/ko/glossary/notified-body 2026-08-11 https://www.pureglobal.com/ko/glossary/pakistan-drap 2026-07-24 https://www.pureglobal.com/ko/glossary/periodic-safety-update-report-psur 2026-07-27 https://www.pureglobal.com/ko/glossary/peru-digemid 2026-07-24 https://www.pureglobal.com/ko/glossary/philippines-fda 2026-07-24 https://www.pureglobal.com/ko/glossary/post-market-surveillance-pms 2026-08-11 https://www.pureglobal.com/ko/glossary/predicate-device 2026-08-11 https://www.pureglobal.com/ko/glossary/premarket-approval-pma 2026-08-11 https://www.pureglobal.com/ko/glossary/qmsr 2026-07-24 https://www.pureglobal.com/ko/glossary/quality-management-system-qms 2026-08-11 https://www.pureglobal.com/ko/glossary/rdc-751-2022 브라질 RDC 751: 등급 분류, 서류 및 라벨링 https://www.pureglobal.com/assets/video-posters/ROnNB17WbreU9JuSaoB6Cp8KZVCGvgjsRyr4W1ZnlAo.jpg 해당 결의안은 이천이십삼년 삼월에 발효되었습니다. https://stream.mux.com/ROnNB17WbreU9JuSaoB6Cp8KZVCGvgjsRyr4W1ZnlAo.m3u8 https://player.mux.com/ROnNB17WbreU9JuSaoB6Cp8KZVCGvgjsRyr4W1ZnlAo?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FROnNB17WbreU9JuSaoB6Cp8KZVCGvgjsRyr4W1ZnlAo.jpg&accent-color=%232451c6 134 2026-09-11T20:03:42.682Z 2026-09-11 https://www.pureglobal.com/ko/glossary/rdc-830-2023 2026-07-27 https://www.pureglobal.com/ko/glossary/saudi-sfda 사우디 SFDA: 의료기기 품목허가 및 현지 역할 https://www.pureglobal.com/assets/video-posters/qnoP53NaW016hP01krGmVWseV8bPu1FpDoTXd01naq01dqk.jpg 사우디 식품의약국(SFDA)은 의료기기와 체외진단의료기기를 규제합니다. https://stream.mux.com/qnoP53NaW016hP01krGmVWseV8bPu1FpDoTXd01naq01dqk.m3u8 https://player.mux.com/qnoP53NaW016hP01krGmVWseV8bPu1FpDoTXd01naq01dqk?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FqnoP53NaW016hP01krGmVWseV8bPu1FpDoTXd01naq01dqk.jpg&accent-color=%232451c6 138 2026-09-11T20:01:32.941Z 2026-09-11 https://www.pureglobal.com/ko/glossary/singapore-hsa 싱가포르 HSA: 의료기기 평가 경로 선택법 https://www.pureglobal.com/assets/video-posters/i3SurxXGlLuOLjq1yBDqHX500iaAePttrT01bzKmzZNL8.jpg HSA는 싱가포르 보건과학청(Health Sciences Authority)입니다. https://stream.mux.com/i3SurxXGlLuOLjq1yBDqHX500iaAePttrT01bzKmzZNL8.m3u8 https://player.mux.com/i3SurxXGlLuOLjq1yBDqHX500iaAePttrT01bzKmzZNL8?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2Fi3SurxXGlLuOLjq1yBDqHX500iaAePttrT01bzKmzZNL8.jpg&accent-color=%232451c6 144 2026-09-11T19:59:30.297Z 2026-09-11 https://www.pureglobal.com/ko/glossary/south-korea-mfds 2026-07-24 https://www.pureglobal.com/ko/glossary/swissmedic 2026-07-24 https://www.pureglobal.com/ko/glossary/taiwan-tfda 2026-07-24 https://www.pureglobal.com/ko/glossary/thailand-fda 태국 FDA: 실무 의료기기 출시 체크리스트 https://www.pureglobal.com/assets/video-posters/ST8brXKmaTnp00P02IjzWFLi3qn3UqYDMxQHal8zxglJU.jpg 태국 FDA는 공중보건부 산하에서 보건 제품을 규제합니다. https://stream.mux.com/ST8brXKmaTnp00P02IjzWFLi3qn3UqYDMxQHal8zxglJU.m3u8 https://player.mux.com/ST8brXKmaTnp00P02IjzWFLi3qn3UqYDMxQHal8zxglJU?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FST8brXKmaTnp00P02IjzWFLi3qn3UqYDMxQHal8zxglJU.jpg&accent-color=%232451c6 128 2026-09-11T19:51:08.999Z 2026-09-11 https://www.pureglobal.com/ko/glossary/uae-ede 2026-07-24 https://www.pureglobal.com/ko/glossary/ukca-marking 2026-08-11 https://www.pureglobal.com/ko/glossary/unique-device-identification-udi 2026-07-27 https://www.pureglobal.com/ko/glossary/us-fda 미국 FDA: 의료기기 규제 https://www.pureglobal.com/assets/video-posters/J7lElt7fst3xxIh2KjnM81YMqzOVealMu7YBI5ypv1c.jpg FDA 및 CDRH, 의료기기 위험 등급, 제출 경로 및 사용자 수수료에 대해 소개합니다. https://stream.mux.com/J7lElt7fst3xxIh2KjnM81YMqzOVealMu7YBI5ypv1c.m3u8 https://player.mux.com/J7lElt7fst3xxIh2KjnM81YMqzOVealMu7YBI5ypv1c?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FJ7lElt7fst3xxIh2KjnM81YMqzOVealMu7YBI5ypv1c.jpg&accent-color=%232451c6 118 2026-10-16T04:57:21.163Z 2026-07-24 https://www.pureglobal.com/ko/glossary/vietnam-moh 2026-07-24 https://www.pureglobal.com/ko/glossary/what-is-eudamed 2026-07-24 https://www.pureglobal.com/ko/glossary/what-is-swissdamed 2026-10-15 https://www.pureglobal.com/ko/glossary/what-is-the-artg 호주 ARTG: 스폰서 및 TGA 수수료 https://www.pureglobal.com/assets/video-posters/ctdHI00Tr9g6pU1RmSJtpiyysaG7vvsZeEA02y01TOsHhg.jpg 호주 ARTG의 적용 대상과 의료기기 스폰서, 등록 및 TGA 수수료가 어떻게 연계되는지 알아봅니다. https://stream.mux.com/ctdHI00Tr9g6pU1RmSJtpiyysaG7vvsZeEA02y01TOsHhg.m3u8 https://player.mux.com/ctdHI00Tr9g6pU1RmSJtpiyysaG7vvsZeEA02y01TOsHhg?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FctdHI00Tr9g6pU1RmSJtpiyysaG7vvsZeEA02y01TOsHhg.jpg&accent-color=%232451c6 115 2026-10-16T04:57:03.866Z 2026-07-24 https://www.pureglobal.com/ko/glossary/what-is-the-therapeutic-goods-act-1989-australia 2026-07-27 https://www.pureglobal.com/pt/glossary/anatel ANATEL no Brasil: Seu Dispositivo Precisa? https://www.pureglobal.com/assets/video-posters/2kjDRrmC01o02EgPyoQIq01AWl3wjZamMzEKd00cpxiM8UY.jpg Saiba quando um dispositivo médico conectado pode precisar da homologação de rádio da ANATEL no Brasil e o que o processo envolve. https://stream.mux.com/2kjDRrmC01o02EgPyoQIq01AWl3wjZamMzEKd00cpxiM8UY.m3u8 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https://www.pureglobal.com/pt/glossary/asean-csdt 2026-07-27 https://www.pureglobal.com/pt/glossary/asean-medical-device-directive-amdd 2026-07-27 https://www.pureglobal.com/pt/glossary/australia-tga 2026-07-24 https://www.pureglobal.com/pt/glossary/bangladesh-dgda 2026-07-24 https://www.pureglobal.com/pt/glossary/breakthrough-devices-program 2026-08-11 https://www.pureglobal.com/pt/glossary/ce-marking 2026-08-11 https://www.pureglobal.com/pt/glossary/certificate-of-free-sale 2026-07-27 https://www.pureglobal.com/pt/glossary/china-nmpa 2026-07-24 https://www.pureglobal.com/pt/glossary/clia-waiver 2026-08-11 https://www.pureglobal.com/pt/glossary/cofepris COFEPRIS: O que checar para dispositivos no México https://www.pureglobal.com/assets/video-posters/fl7iahElcxyZ02h9jDK57uP2qadMKRwNLd3qfQ3MtRt8.jpg A COFEPRIS é o órgão federal de proteção contra riscos sanitários do México, vinculado à Secretaria de Saúde. https://stream.mux.com/fl7iahElcxyZ02h9jDK57uP2qadMKRwNLd3qfQ3MtRt8.m3u8 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https://www.pureglobal.com/assets/video-posters/Hl7AzAVmtNySkMH3nQ02EY2CVVXbXPcQSEZ00sdghyrgE.jpg Publicado em dois mil e cinco, o decreto regulamenta os dispositivos médicos para uso humano na Colômbia. https://stream.mux.com/Hl7AzAVmtNySkMH3nQ02EY2CVVXbXPcQSEZ00sdghyrgE.m3u8 https://player.mux.com/Hl7AzAVmtNySkMH3nQ02EY2CVVXbXPcQSEZ00sdghyrgE?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FHl7AzAVmtNySkMH3nQ02EY2CVVXbXPcQSEZ00sdghyrgE.jpg&accent-color=%232451c6 149 2026-09-11T19:58:38.038Z 2026-09-11 https://www.pureglobal.com/pt/glossary/design-controls 2026-08-11 https://www.pureglobal.com/pt/glossary/design-history-file-dhf 2026-08-11 https://www.pureglobal.com/pt/glossary/egypt-eda 2026-07-24 https://www.pureglobal.com/pt/glossary/electronic-instructions-for-use-eifu 2026-08-11 https://www.pureglobal.com/pt/glossary/eu-declaration-of-conformity 2026-07-27 https://www.pureglobal.com/pt/glossary/eu-mdcg MDCG: Guias de Dispositivos Médicos da UE https://www.pureglobal.com/assets/video-posters/vFXhHIvNgSwdjUa7Pv00wjCvN514HND1ata2JxDqcm900.jpg Saiba o que o Medical Device Coordination Group da UE faz e como seus guias apoiam a implementação do MDR e do IVDR. https://stream.mux.com/vFXhHIvNgSwdjUa7Pv00wjCvN514HND1ata2JxDqcm900.m3u8 https://player.mux.com/vFXhHIvNgSwdjUa7Pv00wjCvN514HND1ata2JxDqcm900?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FvFXhHIvNgSwdjUa7Pv00wjCvN514HND1ata2JxDqcm900.jpg&accent-color=%232451c6 109 2026-10-16T04:58:05.790Z 2026-07-27 https://www.pureglobal.com/pt/glossary/eu-mdr 2026-08-11 https://www.pureglobal.com/pt/glossary/european-commission 2026-07-24 https://www.pureglobal.com/pt/glossary/fda-21-cfr-part-11 2026-08-11 https://www.pureglobal.com/pt/glossary/fda-510k-premarket-notification 2026-08-11 https://www.pureglobal.com/pt/glossary/fda-form-483 2026-08-11 https://www.pureglobal.com/pt/glossary/fda-product-code 2026-08-11 https://www.pureglobal.com/pt/glossary/fda-recall-classes 2026-08-11 https://www.pureglobal.com/pt/glossary/fda-warning-letter 2026-08-11 https://www.pureglobal.com/pt/glossary/field-safety-corrective-action-fsca 2026-07-27 https://www.pureglobal.com/pt/glossary/general-safety-and-performance-requirements-gspr 2026-07-27 https://www.pureglobal.com/pt/glossary/gmdn 2026-07-27 https://www.pureglobal.com/pt/glossary/gudid 2026-08-11 https://www.pureglobal.com/pt/glossary/health-canada-hc Health Canada: MDEL e MDL Explicados https://www.pureglobal.com/assets/video-posters/Elr3pp02daZ3cHrUOfyy5s2nYlMc00xm9IywdsJB1pc8A.jpg Entenda a MDEL e a MDL, as classes de dispositivos médicos do Canadá e as taxas de licenciamento abordadas neste vídeo. https://stream.mux.com/Elr3pp02daZ3cHrUOfyy5s2nYlMc00xm9IywdsJB1pc8A.m3u8 https://player.mux.com/Elr3pp02daZ3cHrUOfyy5s2nYlMc00xm9IywdsJB1pc8A?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FElr3pp02daZ3cHrUOfyy5s2nYlMc00xm9IywdsJB1pc8A.jpg&accent-color=%232451c6 111 2026-10-16T04:57:20.641Z 2026-07-24 https://www.pureglobal.com/pt/glossary/hong-kong-mdd 2026-07-24 https://www.pureglobal.com/pt/glossary/iec-60601-1 2026-07-27 https://www.pureglobal.com/pt/glossary/iec-60601-1-2 2026-08-11 https://www.pureglobal.com/pt/glossary/iec-62304 2026-07-27 https://www.pureglobal.com/pt/glossary/iec-62366-1 2026-07-27 https://www.pureglobal.com/pt/glossary/iec-81001-5-1 2026-07-27 https://www.pureglobal.com/pt/glossary/imda IMDA do Vietnã: Classes de Dispositivos e Registro https://www.pureglobal.com/assets/video-posters/ZeTHNh2Kol01XXJq1OHedf7LxxsqvCMugJssLn2Q1Vr4.jpg Conheça a IMDA do Vietnã e explore as classes A–D de dispositivos médicos, vias de registro e taxas. 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https://stream.mux.com/6VHfOLqokbmjvm0157534U1CEumk4LhdnLXa00ZB87XJI.m3u8 https://player.mux.com/6VHfOLqokbmjvm0157534U1CEumk4LhdnLXa00ZB87XJI?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F6VHfOLqokbmjvm0157534U1CEumk4LhdnLXa00ZB87XJI.jpg&accent-color=%232451c6 107 2026-10-16T04:58:22.372Z 2026-08-11 https://www.pureglobal.com/pt/glossary/invima INVIMA: Seu roteiro de dispositivos na Colômbia https://www.pureglobal.com/assets/video-posters/ErQo88UmMAw5snYmuJ8qY2Go6pg5fZurEFHQdge005mU.jpg O INVIMA é o órgão regulador de produtos para a saúde da Colômbia. https://stream.mux.com/ErQo88UmMAw5snYmuJ8qY2Go6pg5fZurEFHQdge005mU.m3u8 https://player.mux.com/ErQo88UmMAw5snYmuJ8qY2Go6pg5fZurEFHQdge005mU?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FErQo88UmMAw5snYmuJ8qY2Go6pg5fZurEFHQdge005mU.jpg&accent-color=%232451c6 137 2026-09-11T19:46:06.666Z 2026-09-11 https://www.pureglobal.com/pt/glossary/iso-10993 2026-07-27 https://www.pureglobal.com/pt/glossary/iso-11135 2026-07-27 https://www.pureglobal.com/pt/glossary/iso-11137 2026-07-27 https://www.pureglobal.com/pt/glossary/iso-11607 2026-07-27 https://www.pureglobal.com/pt/glossary/iso-13485 2026-07-27 https://www.pureglobal.com/pt/glossary/iso-14155 2026-07-27 https://www.pureglobal.com/pt/glossary/iso-14644 2026-08-11 https://www.pureglobal.com/pt/glossary/iso-14971 2026-07-27 https://www.pureglobal.com/pt/glossary/iso-15223-1 ISO 15223-1: O que os rótulos de dispositivos precisam dizer https://www.pureglobal.com/assets/video-posters/C01jiIrvHfE00vNzR63102Gyw6tadtyaAVVLBgwo8tjHIo.jpg A norma especifica símbolos para informações fornecidas com dispositivos médicos. https://stream.mux.com/C01jiIrvHfE00vNzR63102Gyw6tadtyaAVVLBgwo8tjHIo.m3u8 https://player.mux.com/C01jiIrvHfE00vNzR63102Gyw6tadtyaAVVLBgwo8tjHIo?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FC01jiIrvHfE00vNzR63102Gyw6tadtyaAVVLBgwo8tjHIo.jpg&accent-color=%232451c6 139 2026-09-11T19:56:20.798Z 2026-09-11 https://www.pureglobal.com/pt/glossary/iso-17665 2026-07-27 https://www.pureglobal.com/pt/glossary/iso-20417 2026-07-27 https://www.pureglobal.com/pt/glossary/israel-amar 2026-07-24 https://www.pureglobal.com/pt/glossary/japan-mhlw Japão: MHLW e PMDA: Quem Faz o Quê? https://www.pureglobal.com/assets/video-posters/5ogtx00oPqy9vse7fsFWvgsuWew00m00kJDy1OLeAG1SsY.jpg O Ministério da Saúde, Trabalho e Bem-Estar do Japão detém a autoridade administrativa para aprovações de dispositivos. https://stream.mux.com/5ogtx00oPqy9vse7fsFWvgsuWew00m00kJDy1OLeAG1SsY.m3u8 https://player.mux.com/5ogtx00oPqy9vse7fsFWvgsuWew00m00kJDy1OLeAG1SsY?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F5ogtx00oPqy9vse7fsFWvgsuWew00m00kJDy1OLeAG1SsY.jpg&accent-color=%232451c6 146 2026-09-11T19:50:13.362Z 2026-09-11 https://www.pureglobal.com/pt/glossary/japan-pmda PMDA do Japão: Vias e Prazos de Análise https://www.pureglobal.com/assets/video-posters/dKRTxxT02r8v9kMX6ns5rG3dmEE9ap73mU5cX36R25Hw.jpg Guia em vídeo sobre a PMDA do Japão, classes de dispositivos, notificação, certificação, aprovação ministerial e prazos de análise. https://stream.mux.com/dKRTxxT02r8v9kMX6ns5rG3dmEE9ap73mU5cX36R25Hw.m3u8 https://player.mux.com/dKRTxxT02r8v9kMX6ns5rG3dmEE9ap73mU5cX36R25Hw?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FdKRTxxT02r8v9kMX6ns5rG3dmEE9ap73mU5cX36R25Hw.jpg&accent-color=%232451c6 103 2026-10-16T04:56:46.728Z 2026-07-24 https://www.pureglobal.com/pt/glossary/laboratory-developed-test-ldt 2026-08-11 https://www.pureglobal.com/pt/glossary/macau-isaf 2026-07-24 https://www.pureglobal.com/pt/glossary/malaysia-mda MDA da Malásia: Regulação de Dispositivos Médicos https://www.pureglobal.com/assets/video-posters/11KfReMlINv12OFt8uFn4qlyx300rCqE02ukcSqql4XFI.jpg Visão geral da Medical Device Authority da Malásia, registro de dispositivos, representação local e taxas da Classe A. https://stream.mux.com/11KfReMlINv12OFt8uFn4qlyx300rCqE02ukcSqql4XFI.m3u8 https://player.mux.com/11KfReMlINv12OFt8uFn4qlyx300rCqE02ukcSqql4XFI?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F11KfReMlINv12OFt8uFn4qlyx300rCqE02ukcSqql4XFI.jpg&accent-color=%232451c6 110 2026-10-16T04:56:46.830Z 2026-07-24 https://www.pureglobal.com/pt/glossary/maude-database 2026-08-11 https://www.pureglobal.com/pt/glossary/mdall 2026-08-11 https://www.pureglobal.com/pt/glossary/mdsap 2026-07-27 https://www.pureglobal.com/pt/glossary/medical-device-classification 2026-07-27 https://www.pureglobal.com/pt/glossary/medical-device-reporting-mdr 2026-08-11 https://www.pureglobal.com/pt/glossary/medical-device-technical-file 2026-07-27 https://www.pureglobal.com/pt/glossary/medsafe 2026-07-24 https://www.pureglobal.com/pt/glossary/medwatch 2026-08-11 https://www.pureglobal.com/pt/glossary/mexico-general-health-law Lei Geral de Saúde do México explicada https://www.pureglobal.com/assets/video-posters/WZwBP7wW9GvsGPGb8N01KerYZHtvV9JRvnfHRpOOIaxk.jpg Introdução prática para equipes de dispositivos médicos: o marco legal, o papel de COFEPRIS e três verificações antes de planejar a submissão. https://stream.mux.com/WZwBP7wW9GvsGPGb8N01KerYZHtvV9JRvnfHRpOOIaxk.m3u8 https://player.mux.com/WZwBP7wW9GvsGPGb8N01KerYZHtvV9JRvnfHRpOOIaxk?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FWZwBP7wW9GvsGPGb8N01KerYZHtvV9JRvnfHRpOOIaxk.jpg&accent-color=%232451c6 123 2026-09-11T05:34:23.870Z 2026-09-11 https://www.pureglobal.com/pt/glossary/mhra MHRA: Regras Britânicas de Dispositivos https://www.pureglobal.com/assets/video-posters/PiCcyO02oZcLiqy7n3tHnXD2lZRah9m01cMKWrB67HxIY.jpg Um guia sobre a MHRA, a regulação de dispositivos médicos no Reino Unido e as vias de marcação CE e UKCA abordadas neste vídeo. https://stream.mux.com/PiCcyO02oZcLiqy7n3tHnXD2lZRah9m01cMKWrB67HxIY.m3u8 https://player.mux.com/PiCcyO02oZcLiqy7n3tHnXD2lZRah9m01cMKWrB67HxIY?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FPiCcyO02oZcLiqy7n3tHnXD2lZRah9m01cMKWrB67HxIY.jpg&accent-color=%232451c6 107 2026-10-16T04:57:38.088Z 2026-07-24 https://www.pureglobal.com/pt/glossary/notified-body 2026-08-11 https://www.pureglobal.com/pt/glossary/pakistan-drap 2026-07-24 https://www.pureglobal.com/pt/glossary/periodic-safety-update-report-psur 2026-07-27 https://www.pureglobal.com/pt/glossary/peru-digemid 2026-07-24 https://www.pureglobal.com/pt/glossary/philippines-fda 2026-07-24 https://www.pureglobal.com/pt/glossary/post-market-surveillance-pms 2026-08-11 https://www.pureglobal.com/pt/glossary/predicate-device 2026-08-11 https://www.pureglobal.com/pt/glossary/premarket-approval-pma 2026-08-11 https://www.pureglobal.com/pt/glossary/qmsr 2026-07-24 https://www.pureglobal.com/pt/glossary/quality-management-system-qms 2026-08-11 https://www.pureglobal.com/pt/glossary/rdc-751-2022 RDC 751 no Brasil: classificação, dossiê e rotulagem https://www.pureglobal.com/assets/video-posters/KqejtQK7vLBfgO01QvgMcyNc2SlpvwuIgLeqNNS012vYQ.jpg A resolução entrou em vigor em março de dois mil e vinte e três. https://stream.mux.com/KqejtQK7vLBfgO01QvgMcyNc2SlpvwuIgLeqNNS012vYQ.m3u8 https://player.mux.com/KqejtQK7vLBfgO01QvgMcyNc2SlpvwuIgLeqNNS012vYQ?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FKqejtQK7vLBfgO01QvgMcyNc2SlpvwuIgLeqNNS012vYQ.jpg&accent-color=%232451c6 149 2026-09-11T20:04:53.832Z 2026-09-11 https://www.pureglobal.com/pt/glossary/rdc-830-2023 2026-07-27 https://www.pureglobal.com/pt/glossary/saudi-sfda SFDA Saudita: Autorização de Dispositivos e Papéis Locais https://www.pureglobal.com/assets/video-posters/2D6ncGq2QCjLhrJhYqfIC8JwT01vfMsP7s2WNvW41nWQ.jpg A Saudi Food and Drug Authority regulamenta dispositivos médicos e produtos para diagnóstico in vitro. https://stream.mux.com/2D6ncGq2QCjLhrJhYqfIC8JwT01vfMsP7s2WNvW41nWQ.m3u8 https://player.mux.com/2D6ncGq2QCjLhrJhYqfIC8JwT01vfMsP7s2WNvW41nWQ?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F2D6ncGq2QCjLhrJhYqfIC8JwT01vfMsP7s2WNvW41nWQ.jpg&accent-color=%232451c6 144 2026-09-11T20:02:45.263Z 2026-09-11 https://www.pureglobal.com/pt/glossary/singapore-hsa Singapura HSA: Como Escolher a Via do Dispositivo https://www.pureglobal.com/assets/video-posters/INBq2hEoU02RiBCuC021aqxXIIWQgX1EBDdBxW1a5zPqA.jpg A HSA é a Health Sciences Authority de Singapura. https://stream.mux.com/INBq2hEoU02RiBCuC021aqxXIIWQgX1EBDdBxW1a5zPqA.m3u8 https://player.mux.com/INBq2hEoU02RiBCuC021aqxXIIWQgX1EBDdBxW1a5zPqA?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FINBq2hEoU02RiBCuC021aqxXIIWQgX1EBDdBxW1a5zPqA.jpg&accent-color=%232451c6 143 2026-09-11T20:00:34.886Z 2026-09-11 https://www.pureglobal.com/pt/glossary/south-korea-mfds 2026-07-24 https://www.pureglobal.com/pt/glossary/swissmedic 2026-07-24 https://www.pureglobal.com/pt/glossary/taiwan-tfda 2026-07-24 https://www.pureglobal.com/pt/glossary/thailand-fda FDA da Tailândia: checklist prático de lançamento https://www.pureglobal.com/assets/video-posters/Wf7dBvpnNdNDqSAqp4qRq01sNmY0201IxUwX5XtnDz8g6Q.jpg A FDA da Tailândia regulamenta produtos para a saúde sob o Ministério da Saúde Pública. https://stream.mux.com/Wf7dBvpnNdNDqSAqp4qRq01sNmY0201IxUwX5XtnDz8g6Q.m3u8 https://player.mux.com/Wf7dBvpnNdNDqSAqp4qRq01sNmY0201IxUwX5XtnDz8g6Q?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FWf7dBvpnNdNDqSAqp4qRq01sNmY0201IxUwX5XtnDz8g6Q.jpg&accent-color=%232451c6 135 2026-09-11T19:52:14.702Z 2026-09-11 https://www.pureglobal.com/pt/glossary/uae-ede 2026-07-24 https://www.pureglobal.com/pt/glossary/ukca-marking 2026-08-11 https://www.pureglobal.com/pt/glossary/unique-device-identification-udi 2026-07-27 https://www.pureglobal.com/pt/glossary/us-fda FDA dos EUA: Regulação de Dispositivos https://www.pureglobal.com/assets/video-posters/J7lElt7fst3xxIh2KjnM81YMqzOVealMu7YBI5ypv1c.jpg Uma introdução à FDA e ao CDRH, classes de risco de dispositivos médicos, vias de submissão e taxas de usuário. https://stream.mux.com/J7lElt7fst3xxIh2KjnM81YMqzOVealMu7YBI5ypv1c.m3u8 https://player.mux.com/J7lElt7fst3xxIh2KjnM81YMqzOVealMu7YBI5ypv1c?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FJ7lElt7fst3xxIh2KjnM81YMqzOVealMu7YBI5ypv1c.jpg&accent-color=%232451c6 118 2026-10-16T04:57:21.163Z 2026-07-24 https://www.pureglobal.com/pt/glossary/vietnam-moh 2026-07-24 https://www.pureglobal.com/pt/glossary/what-is-eudamed 2026-07-24 https://www.pureglobal.com/pt/glossary/what-is-swissdamed 2026-10-15 https://www.pureglobal.com/pt/glossary/what-is-the-artg Austrália ARTG: Sponsors e Taxas da TGA https://www.pureglobal.com/assets/video-posters/ctdHI00Tr9g6pU1RmSJtpiyysaG7vvsZeEA02y01TOsHhg.jpg Saiba o que o ARTG da Austrália cobre e como sponsors de dispositivos, registro e taxas da TGA se integram. https://stream.mux.com/ctdHI00Tr9g6pU1RmSJtpiyysaG7vvsZeEA02y01TOsHhg.m3u8 https://player.mux.com/ctdHI00Tr9g6pU1RmSJtpiyysaG7vvsZeEA02y01TOsHhg?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FctdHI00Tr9g6pU1RmSJtpiyysaG7vvsZeEA02y01TOsHhg.jpg&accent-color=%232451c6 115 2026-10-16T04:57:03.866Z 2026-07-24 https://www.pureglobal.com/pt/glossary/what-is-the-therapeutic-goods-act-1989-australia 2026-07-27 https://www.pureglobal.com/zh/glossary/anatel 巴西ANATEL：您的器械是否需要？ https://www.pureglobal.com/assets/video-posters/2kjDRrmC01o02EgPyoQIq01AWl3wjZamMzEKd00cpxiM8UY.jpg 了解互联医疗器械何时可能需要在巴西获得ANATEL无线电型号核准，以及该流程涉及的具体环节。 https://stream.mux.com/2kjDRrmC01o02EgPyoQIq01AWl3wjZamMzEKd00cpxiM8UY.m3u8 https://player.mux.com/2kjDRrmC01o02EgPyoQIq01AWl3wjZamMzEKd00cpxiM8UY?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F2kjDRrmC01o02EgPyoQIq01AWl3wjZamMzEKd00cpxiM8UY.jpg&accent-color=%232451c6 107 2026-10-16T04:57:36.091Z 2026-07-27 https://www.pureglobal.com/zh/glossary/anmat 2026-07-24 https://www.pureglobal.com/zh/glossary/anvisa ANVISA：巴西医疗器械团队须知 https://www.pureglobal.com/assets/video-posters/kOz5Sb8VUw6q6nPUDAqrW7XLAdF00j3x4gINURRWUOx8.jpg ANVISA 是巴西的国家卫生监督机构。 https://stream.mux.com/kOz5Sb8VUw6q6nPUDAqrW7XLAdF00j3x4gINURRWUOx8.m3u8 https://player.mux.com/kOz5Sb8VUw6q6nPUDAqrW7XLAdF00j3x4gINURRWUOx8?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FkOz5Sb8VUw6q6nPUDAqrW7XLAdF00j3x4gINURRWUOx8.jpg&accent-color=%232451c6 117 2026-09-11T19:47:28.186Z 2026-09-11 https://www.pureglobal.com/zh/glossary/asean-csdt 2026-07-27 https://www.pureglobal.com/zh/glossary/asean-medical-device-directive-amdd 2026-07-27 https://www.pureglobal.com/zh/glossary/australia-tga 2026-07-24 https://www.pureglobal.com/zh/glossary/bangladesh-dgda 2026-07-24 https://www.pureglobal.com/zh/glossary/breakthrough-devices-program 2026-08-11 https://www.pureglobal.com/zh/glossary/ce-marking 2026-08-11 https://www.pureglobal.com/zh/glossary/certificate-of-free-sale 2026-07-27 https://www.pureglobal.com/zh/glossary/china-nmpa 2026-07-24 https://www.pureglobal.com/zh/glossary/clia-waiver 2026-08-11 https://www.pureglobal.com/zh/glossary/cofepris COFEPRIS：墨西哥医疗器械团队核对要点 https://www.pureglobal.com/assets/video-posters/FxkrMNizIXat1gDIhmj017hDw01Sf3gtr8502pl2DB6zsY.jpg COFEPRIS 是墨西哥卫生部下属的联邦卫生风险监管机构。 https://stream.mux.com/FxkrMNizIXat1gDIhmj017hDw01Sf3gtr8502pl2DB6zsY.m3u8 https://player.mux.com/FxkrMNizIXat1gDIhmj017hDw01Sf3gtr8502pl2DB6zsY?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FFxkrMNizIXat1gDIhmj017hDw01Sf3gtr8502pl2DB6zsY.jpg&accent-color=%232451c6 119 2026-09-11T19:53:34.072Z 2026-09-11 https://www.pureglobal.com/zh/glossary/combination-product 2026-08-11 https://www.pureglobal.com/zh/glossary/companion-diagnostics 2026-08-11 https://www.pureglobal.com/zh/glossary/conformity-assessment 2026-07-27 https://www.pureglobal.com/zh/glossary/corrective-and-preventive-action-capa 2026-08-11 https://www.pureglobal.com/zh/glossary/costa-rica-ministry-of-health 2026-07-24 https://www.pureglobal.com/zh/glossary/current-good-manufacturing-practice-cgmp 2026-08-11 https://www.pureglobal.com/zh/glossary/de-novo-classification 2026-08-11 https://www.pureglobal.com/zh/glossary/decree-3770-of-2004 2026-07-27 https://www.pureglobal.com/zh/glossary/decree-4725-2005 哥伦比亚第4725号法令：梳理医疗器械要求 https://www.pureglobal.com/assets/video-posters/bW01mhhW9ZYAaCelwyXEHJfVRChbqmuYTwVlApdDMq6E.jpg 该法令于二零零五年颁布，监管哥伦比亚境内的人用医疗器械。 https://stream.mux.com/bW01mhhW9ZYAaCelwyXEHJfVRChbqmuYTwVlApdDMq6E.m3u8 https://player.mux.com/bW01mhhW9ZYAaCelwyXEHJfVRChbqmuYTwVlApdDMq6E?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FbW01mhhW9ZYAaCelwyXEHJfVRChbqmuYTwVlApdDMq6E.jpg&accent-color=%232451c6 131 2026-09-11T19:57:47.697Z 2026-09-11 https://www.pureglobal.com/zh/glossary/design-controls 2026-08-11 https://www.pureglobal.com/zh/glossary/design-history-file-dhf 2026-08-11 https://www.pureglobal.com/zh/glossary/egypt-eda 2026-07-24 https://www.pureglobal.com/zh/glossary/electronic-instructions-for-use-eifu 2026-08-11 https://www.pureglobal.com/zh/glossary/eu-declaration-of-conformity 2026-07-27 https://www.pureglobal.com/zh/glossary/eu-mdcg MDCG：欧盟医疗器械指南 https://www.pureglobal.com/assets/video-posters/vFXhHIvNgSwdjUa7Pv00wjCvN514HND1ata2JxDqcm900.jpg 了解欧盟医疗器械协调小组的职责，以及其指导文件如何支持MDR与IVDR的实施。 https://stream.mux.com/vFXhHIvNgSwdjUa7Pv00wjCvN514HND1ata2JxDqcm900.m3u8 https://player.mux.com/vFXhHIvNgSwdjUa7Pv00wjCvN514HND1ata2JxDqcm900?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FvFXhHIvNgSwdjUa7Pv00wjCvN514HND1ata2JxDqcm900.jpg&accent-color=%232451c6 109 2026-10-16T04:58:05.790Z 2026-07-27 https://www.pureglobal.com/zh/glossary/eu-mdr 2026-08-11 https://www.pureglobal.com/zh/glossary/european-commission 2026-07-24 https://www.pureglobal.com/zh/glossary/fda-21-cfr-part-11 2026-08-11 https://www.pureglobal.com/zh/glossary/fda-510k-premarket-notification 2026-08-11 https://www.pureglobal.com/zh/glossary/fda-form-483 2026-08-11 https://www.pureglobal.com/zh/glossary/fda-product-code 2026-08-11 https://www.pureglobal.com/zh/glossary/fda-recall-classes 2026-08-11 https://www.pureglobal.com/zh/glossary/fda-warning-letter 2026-08-11 https://www.pureglobal.com/zh/glossary/field-safety-corrective-action-fsca 2026-07-27 https://www.pureglobal.com/zh/glossary/general-safety-and-performance-requirements-gspr 2026-07-27 https://www.pureglobal.com/zh/glossary/gmdn 2026-07-27 https://www.pureglobal.com/zh/glossary/gudid 2026-08-11 https://www.pureglobal.com/zh/glossary/health-canada-hc 加拿大卫生部：MDEL与MDL解析 https://www.pureglobal.com/assets/video-posters/Elr3pp02daZ3cHrUOfyy5s2nYlMc00xm9IywdsJB1pc8A.jpg 了解本视频涵盖的MDEL与MDL、加拿大医疗器械分类及许可费用。 https://stream.mux.com/Elr3pp02daZ3cHrUOfyy5s2nYlMc00xm9IywdsJB1pc8A.m3u8 https://player.mux.com/Elr3pp02daZ3cHrUOfyy5s2nYlMc00xm9IywdsJB1pc8A?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FElr3pp02daZ3cHrUOfyy5s2nYlMc00xm9IywdsJB1pc8A.jpg&accent-color=%232451c6 111 2026-10-16T04:57:20.641Z 2026-07-24 https://www.pureglobal.com/zh/glossary/hong-kong-mdd 2026-07-24 https://www.pureglobal.com/zh/glossary/iec-60601-1 2026-07-27 https://www.pureglobal.com/zh/glossary/iec-60601-1-2 2026-08-11 https://www.pureglobal.com/zh/glossary/iec-62304 2026-07-27 https://www.pureglobal.com/zh/glossary/iec-62366-1 2026-07-27 https://www.pureglobal.com/zh/glossary/iec-81001-5-1 2026-07-27 https://www.pureglobal.com/zh/glossary/imda 越南IMDA：器械分类与注册 https://www.pureglobal.com/assets/video-posters/ZeTHNh2Kol01XXJq1OHedf7LxxsqvCMugJssLn2Q1Vr4.jpg 走近越南IMDA，深入了解A–D类医疗器械分类、注册路径及相关费用。 https://stream.mux.com/ZeTHNh2Kol01XXJq1OHedf7LxxsqvCMugJssLn2Q1Vr4.m3u8 https://player.mux.com/ZeTHNh2Kol01XXJq1OHedf7LxxsqvCMugJssLn2Q1Vr4?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FZeTHNh2Kol01XXJq1OHedf7LxxsqvCMugJssLn2Q1Vr4.jpg&accent-color=%232451c6 107 2026-10-16T04:57:54.771Z 2026-07-24 https://www.pureglobal.com/zh/glossary/imdrf 2026-07-27 https://www.pureglobal.com/zh/glossary/india-cdsco 2026-07-24 https://www.pureglobal.com/zh/glossary/indonesia-moh 2026-07-27 https://www.pureglobal.com/zh/glossary/inmetro 2026-07-27 https://www.pureglobal.com/zh/glossary/investigational-device-exemption-ide FDA IDE：研究用器械豁免 https://www.pureglobal.com/assets/video-posters/6VHfOLqokbmjvm0157534U1CEumk4LhdnLXa00ZB87XJI.jpg 了解研究用器械豁免如何适用于器械研究、风险判定及FDA审批。 https://stream.mux.com/6VHfOLqokbmjvm0157534U1CEumk4LhdnLXa00ZB87XJI.m3u8 https://player.mux.com/6VHfOLqokbmjvm0157534U1CEumk4LhdnLXa00ZB87XJI?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F6VHfOLqokbmjvm0157534U1CEumk4LhdnLXa00ZB87XJI.jpg&accent-color=%232451c6 107 2026-10-16T04:58:22.372Z 2026-08-11 https://www.pureglobal.com/zh/glossary/invima INVIMA：您的哥伦比亚医疗器械路线图 https://www.pureglobal.com/assets/video-posters/tlhXbdcjzJr02fiv02brj2wlhUPbFPC601wUIKB01Q1XKoU.jpg INVIMA 是哥伦比亚国家卫生产品监管机构。 https://stream.mux.com/tlhXbdcjzJr02fiv02brj2wlhUPbFPC601wUIKB01Q1XKoU.m3u8 https://player.mux.com/tlhXbdcjzJr02fiv02brj2wlhUPbFPC601wUIKB01Q1XKoU?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FtlhXbdcjzJr02fiv02brj2wlhUPbFPC601wUIKB01Q1XKoU.jpg&accent-color=%232451c6 115 2026-09-11T19:45:27.163Z 2026-09-11 https://www.pureglobal.com/zh/glossary/iso-10993 2026-07-27 https://www.pureglobal.com/zh/glossary/iso-11135 2026-07-27 https://www.pureglobal.com/zh/glossary/iso-11137 2026-07-27 https://www.pureglobal.com/zh/glossary/iso-11607 2026-07-27 https://www.pureglobal.com/zh/glossary/iso-13485 2026-07-27 https://www.pureglobal.com/zh/glossary/iso-14155 2026-07-27 https://www.pureglobal.com/zh/glossary/iso-14644 2026-08-11 https://www.pureglobal.com/zh/glossary/iso-14971 2026-07-27 https://www.pureglobal.com/zh/glossary/iso-15223-1 ISO 15223-1：医疗器械标签应包含的内容 https://www.pureglobal.com/assets/video-posters/3u57zMukJrNPLQWPGJEdaTq17Hwj00mqHR715u5t016qY.jpg 该标准规定了随附医疗器械提供信息的符号。 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https://player.mux.com/U15jTq8oUzCKD01mFUIQk6j8JdBAK78imVvOIh2Z45fg?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FU15jTq8oUzCKD01mFUIQk6j8JdBAK78imVvOIh2Z45fg.jpg&accent-color=%232451c6 124 2026-09-11T19:49:31.797Z 2026-09-11 https://www.pureglobal.com/zh/glossary/japan-pmda 日本PMDA：器械路径与审评时限 https://www.pureglobal.com/assets/video-posters/dKRTxxT02r8v9kMX6ns5rG3dmEE9ap73mU5cX36R25Hw.jpg 关于日本PMDA、器械分类、备案、认证、厚生劳动省审批及审评时限的视频指南。 https://stream.mux.com/dKRTxxT02r8v9kMX6ns5rG3dmEE9ap73mU5cX36R25Hw.m3u8 https://player.mux.com/dKRTxxT02r8v9kMX6ns5rG3dmEE9ap73mU5cX36R25Hw?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FdKRTxxT02r8v9kMX6ns5rG3dmEE9ap73mU5cX36R25Hw.jpg&accent-color=%232451c6 103 2026-10-16T04:56:46.728Z 2026-07-24 https://www.pureglobal.com/zh/glossary/laboratory-developed-test-ldt 2026-08-11 https://www.pureglobal.com/zh/glossary/macau-isaf 2026-07-24 https://www.pureglobal.com/zh/glossary/malaysia-mda 马来西亚MDA：医疗器械监管 https://www.pureglobal.com/assets/video-posters/11KfReMlINv12OFt8uFn4qlyx300rCqE02ukcSqql4XFI.jpg 概述马来西亚医疗器械管理局、器械注册、本地代表及A类器械费用。 https://stream.mux.com/11KfReMlINv12OFt8uFn4qlyx300rCqE02ukcSqql4XFI.m3u8 https://player.mux.com/11KfReMlINv12OFt8uFn4qlyx300rCqE02ukcSqql4XFI?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F11KfReMlINv12OFt8uFn4qlyx300rCqE02ukcSqql4XFI.jpg&accent-color=%232451c6 110 2026-10-16T04:56:46.830Z 2026-07-24 https://www.pureglobal.com/zh/glossary/maude-database 2026-08-11 https://www.pureglobal.com/zh/glossary/mdall 2026-08-11 https://www.pureglobal.com/zh/glossary/mdsap 2026-07-27 https://www.pureglobal.com/zh/glossary/medical-device-classification 2026-07-27 https://www.pureglobal.com/zh/glossary/medical-device-reporting-mdr 2026-08-11 https://www.pureglobal.com/zh/glossary/medical-device-technical-file 2026-07-27 https://www.pureglobal.com/zh/glossary/medsafe 2026-07-24 https://www.pureglobal.com/zh/glossary/medwatch 2026-08-11 https://www.pureglobal.com/zh/glossary/mexico-general-health-law 墨西哥《卫生总法》视频讲解 https://www.pureglobal.com/assets/video-posters/9X9FJ00iQZnWlIAUPr7tiCrBS01v02kBvSPNUsb5JPXs2w.jpg 为医疗器械团队梳理法律框架、COFEPRIS 的职责，以及规划注册申报前需要核实的三个要点。 https://stream.mux.com/9X9FJ00iQZnWlIAUPr7tiCrBS01v02kBvSPNUsb5JPXs2w.m3u8 https://player.mux.com/9X9FJ00iQZnWlIAUPr7tiCrBS01v02kBvSPNUsb5JPXs2w?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F9X9FJ00iQZnWlIAUPr7tiCrBS01v02kBvSPNUsb5JPXs2w.jpg&accent-color=%232451c6 108 2026-09-11T04:38:01.602Z 2026-09-11 https://www.pureglobal.com/zh/glossary/mhra MHRA：英国医疗器械法规 https://www.pureglobal.com/assets/video-posters/PiCcyO02oZcLiqy7n3tHnXD2lZRah9m01cMKWrB67HxIY.jpg 关于MHRA、英国医疗器械法规以及本视频所讨论CE与UKCA标志路径的指南。 https://stream.mux.com/PiCcyO02oZcLiqy7n3tHnXD2lZRah9m01cMKWrB67HxIY.m3u8 https://player.mux.com/PiCcyO02oZcLiqy7n3tHnXD2lZRah9m01cMKWrB67HxIY?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FPiCcyO02oZcLiqy7n3tHnXD2lZRah9m01cMKWrB67HxIY.jpg&accent-color=%232451c6 107 2026-10-16T04:57:38.088Z 2026-07-24 https://www.pureglobal.com/zh/glossary/notified-body 2026-08-11 https://www.pureglobal.com/zh/glossary/pakistan-drap 2026-07-24 https://www.pureglobal.com/zh/glossary/periodic-safety-update-report-psur 2026-07-27 https://www.pureglobal.com/zh/glossary/peru-digemid 2026-07-24 https://www.pureglobal.com/zh/glossary/philippines-fda 2026-07-24 https://www.pureglobal.com/zh/glossary/post-market-surveillance-pms 2026-08-11 https://www.pureglobal.com/zh/glossary/predicate-device 2026-08-11 https://www.pureglobal.com/zh/glossary/premarket-approval-pma 2026-08-11 https://www.pureglobal.com/zh/glossary/qmsr 2026-07-24 https://www.pureglobal.com/zh/glossary/quality-management-system-qms 2026-08-11 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https://player.mux.com/Fduso6CZu7q3IEBKAUVrZBuKslWZ3dd01SqF2oOr8Y6g?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FFduso6CZu7q3IEBKAUVrZBuKslWZ3dd01SqF2oOr8Y6g.jpg&accent-color=%232451c6 127 2026-09-11T20:02:00.937Z 2026-09-11 https://www.pureglobal.com/zh/glossary/singapore-hsa 新加坡HSA：器械路径选择指南 https://www.pureglobal.com/assets/video-posters/TMr4n3GteA5Cho9I74UM01AB00wt02f01ovvHRH2UpVeFp00.jpg HSA即新加坡卫生科学局。 https://stream.mux.com/TMr4n3GteA5Cho9I74UM01AB00wt02f01ovvHRH2UpVeFp00.m3u8 https://player.mux.com/TMr4n3GteA5Cho9I74UM01AB00wt02f01ovvHRH2UpVeFp00?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FTMr4n3GteA5Cho9I74UM01AB00wt02f01ovvHRH2UpVeFp00.jpg&accent-color=%232451c6 129 2026-09-11T19:59:55.834Z 2026-09-11 https://www.pureglobal.com/zh/glossary/south-korea-mfds 2026-07-24 https://www.pureglobal.com/zh/glossary/swissmedic 2026-07-24 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https://player.mux.com/ctdHI00Tr9g6pU1RmSJtpiyysaG7vvsZeEA02y01TOsHhg?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FctdHI00Tr9g6pU1RmSJtpiyysaG7vvsZeEA02y01TOsHhg.jpg&accent-color=%232451c6 115 2026-10-16T04:57:03.866Z 2026-07-24 https://www.pureglobal.com/zh/glossary/what-is-the-therapeutic-goods-act-1989-australia 2026-07-27