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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 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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 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 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 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 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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 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 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https://www.pureglobal.com/de/markets/brazil/anvisa-medical-device-regulations 2026-07-24 https://www.pureglobal.com/de/markets/canada 2026-07-24 https://www.pureglobal.com/de/markets/china 2026-07-24 https://www.pureglobal.com/de/markets/colombia 2026-07-24 https://www.pureglobal.com/de/markets/colombia/invima-medical-device-classification 2026-07-24 https://www.pureglobal.com/de/markets/colombia/invima-medical-device-labeling 2026-07-24 https://www.pureglobal.com/de/markets/colombia/invima-medical-device-postmarket-compliance 2026-07-24 https://www.pureglobal.com/de/markets/colombia/invima-medical-device-regulations 2026-07-24 https://www.pureglobal.com/de/markets/costa-rica 2026-07-24 https://www.pureglobal.com/de/markets/egypt 2026-07-24 https://www.pureglobal.com/de/markets/european-union 2026-07-24 https://www.pureglobal.com/de/markets/european-union/ce-mark-notified-body-search 2026-07-27 https://www.pureglobal.com/de/markets/european-union/ec-european-authorized-representative 2026-07-24 https://www.pureglobal.com/de/markets/european-union/eu-ivdr-consulting 2026-07-24 https://www.pureglobal.com/de/markets/european-union/eu-ivdr-consulting/ce-marking-approval-for-ivds 2026-07-24 https://www.pureglobal.com/de/markets/european-union/eu-ivdr-consulting/ivdr-classification 2026-07-24 https://www.pureglobal.com/de/markets/european-union/eu-ivdr-consulting/ivdr-per-performance-evaluation-report 2026-07-24 https://www.pureglobal.com/de/markets/european-union/eu-ivdr-consulting/pmpf-postmarket-performance 2026-07-24 https://www.pureglobal.com/de/markets/european-union/eu-mdr-consulting 2026-07-24 https://www.pureglobal.com/de/markets/european-union/eu-mdr-consulting/eu-mdr-ce-marking-approval-for-medical-devices 2026-07-24 https://www.pureglobal.com/de/markets/european-union/eu-mdr-consulting/eu-mdr-classification-for-medical-devices 2026-07-24 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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/videos/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/videos/mdcg-2025-5-explained-eu-ivdr-rules-for-ivd-performance-studies 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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/videos/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 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2026-07-27 https://www.pureglobal.com/es/glossary/imda 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 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 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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 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https://www.pureglobal.com/es/videos/mdcg-2025-5-explained-eu-ivdr-rules-for-ivd-performance-studies 2025-08-01 https://www.pureglobal.com/es/videos/mexico-general-health-law Ley General de Salud de México: guía en video https://www.pureglobal.com/assets/video-posters/Slva6uB6lemVTWiE00LzwJos1jEsQHKuhvRExmFpU9dI.jpg Vea cómo la Ley General de Salud de México se vincula con COFEPRIS, el registro y tres verificaciones prácticas para equipos de dispositivos médicos. 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/videos/pure-globals-year-in-review-2025 2026-01-06 https://www.pureglobal.com/es/videos/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/videos/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 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https://www.pureglobal.com/fr/blog-posts/surgical-robot-global-market-access-2026 2026-08-10 https://www.pureglobal.com/fr/blog-posts/thailands-medical-device-and-ivd-import-market 2025-09-16 https://www.pureglobal.com/fr/blog-posts/the-eu-parliament-votes-on-a-resolution-to-revise-specific-parts-of-the-mdr-and-ivdr 2025-08-14 https://www.pureglobal.com/fr/blog-posts/the-impact-of-ai-in-the-medtech-sector 2025-08-14 https://www.pureglobal.com/fr/blog-posts/transla-ai-simplifying-multi-language-documentation-for-global-medtech-companies 2025-02-26 https://www.pureglobal.com/fr/blog-posts/udi-us-eu-china-compliance-workorder-2026 2026-09-06 https://www.pureglobal.com/fr/blog-posts/understanding-reimbursement-related-payment-is-a-critical-piece-of-medical-device-market-access-strategy 2025-08-14 https://www.pureglobal.com/fr/blog-posts/untangling-the-regulations-of-health-tech 2025-08-14 https://www.pureglobal.com/fr/blog-posts/us-regulatory-insights-pure-global-collaboration 2025-08-14 https://www.pureglobal.com/fr/blog-posts/what-are-the-challenges-under-ivdr 2025-08-14 https://www.pureglobal.com/fr/blog-posts/why-and-how-eu-ivdr-compliance-matters-before-the-may-2025-deadline 2025-08-14 https://www.pureglobal.com/fr/blog-posts/wireless-compliance-for-medical-device-manufacturers-overview-of-radio-frequency-module-integration 2025-08-14 https://www.pureglobal.com/fr/case-studies 2026-08-10 https://www.pureglobal.com/fr/case-studies/anvisa-registration-class-iv-coronary-balloon-brazil 2026-08-11 https://www.pureglobal.com/fr/case-studies/anvisa-registration-single-use-endoscopes-brazil 2026-08-10 https://www.pureglobal.com/fr/case-studies/cofepris-ivd-registration-mexico 2026-08-10 https://www.pureglobal.com/fr/case-studies/eu-authorized-representative-medical-devices 2026-08-10 https://www.pureglobal.com/fr/case-studies/eu-mdr-class-iii-dermal-filler-registration 2026-08-11 https://www.pureglobal.com/fr/case-studies/eudamed-basic-udi-di-grouping-contrast-media-consumables 2026-08-11 https://www.pureglobal.com/fr/case-studies/invima-medical-device-registration-colombia 2026-08-10 https://www.pureglobal.com/fr/case-studies/vietnam-medical-device-registration 2026-08-10 https://www.pureglobal.com/fr/company/about 2026-07-12 https://www.pureglobal.com/fr/company/in-the-media 2026-07-12 https://www.pureglobal.com/fr/company/locations 2026-09-03 https://www.pureglobal.com/fr/company/our-team 2026-07-12 https://www.pureglobal.com/fr/contact 2026-06-30 https://www.pureglobal.com/fr/devices 2026-07-20 https://www.pureglobal.com/fr/devices/aesthetic-devices 2026-07-20 https://www.pureglobal.com/fr/devices/cardiovascular 2026-07-20 https://www.pureglobal.com/fr/devices/dental 2026-07-20 https://www.pureglobal.com/fr/devices/diabetes-care 2026-07-20 https://www.pureglobal.com/fr/devices/drug-delivery 2026-07-20 https://www.pureglobal.com/fr/devices/ent-audiology 2026-07-20 https://www.pureglobal.com/fr/devices/ivd 2026-07-20 https://www.pureglobal.com/fr/devices/medical-imaging 2026-07-20 https://www.pureglobal.com/fr/devices/neurotech 2026-07-20 https://www.pureglobal.com/fr/devices/ophthalmic 2026-07-20 https://www.pureglobal.com/fr/devices/orthopedics 2026-07-20 https://www.pureglobal.com/fr/devices/patient-care 2026-07-20 https://www.pureglobal.com/fr/devices/rehab-home 2026-07-20 https://www.pureglobal.com/fr/devices/samd 2026-07-20 https://www.pureglobal.com/fr/devices/surgery-robotics 2026-07-20 https://www.pureglobal.com/fr/devices/urology-womens-health 2026-07-20 https://www.pureglobal.com/fr/glossary/anatel 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. 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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 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 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 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 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 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 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 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 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https://www.pureglobal.com/fr/news/philippines-fda-advisory-2026-1007-cpr-renewal-validity 2026-08-30 https://www.pureglobal.com/fr/news/philippines-fda-dc-2025-0382-extension-of-temporary-suspension-on-medical-device-registration-fees 2025-09-10 https://www.pureglobal.com/fr/news/philippines-fda-extends-cmdr-fee-suspension-2026 2026-07-01 https://www.pureglobal.com/fr/news/philippines-fda-temporarily-suspends-medical-device-registration-fees-in-2025 2025-07-29 https://www.pureglobal.com/fr/news/pure-global-achieves-two-new-brazilian-certificates 2025-04-29 https://www.pureglobal.com/fr/news/pure-global-and-medicept-join-forces-to-expand-market-access-services 2025-03-04 https://www.pureglobal.com/fr/news/pure-global-and-medicept-partner-to-drive-medtech-growth-innovation 2025-03-04 https://www.pureglobal.com/fr/news/pure-global-appoints-ran-chen-as-chief-technology-officer 2025-06-02 https://www.pureglobal.com/fr/news/pure-global-eu-regulation-updates-april 2025-12-27 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https://www.pureglobal.com/fr/news/singapore-hsa-uk-fast-track-pathway-2025 2026-03-12 https://www.pureglobal.com/fr/news/sri-lanka-nmra-aesthetic-device-classification-registration-2027 2026-08-09 https://www.pureglobal.com/fr/news/sustainability-continues-to-gain-significant-attention-in-2025 2025-03-14 https://www.pureglobal.com/fr/news/swissmedic-2024-hospital-inspections-report-compliance-gaps-identified 2025-09-03 https://www.pureglobal.com/fr/news/swissmedic-2025-guidance-on-systems-and-procedure-packs 2025-08-12 https://www.pureglobal.com/fr/news/swissmedic-2026-focus-campaign-on-post-market-surveillance-for-higher-risk-medical-devices 2026-04-30 https://www.pureglobal.com/fr/news/swissmedic-launches-swissdamed-udi-devices-module-ahead-of-2026-compliance-deadline 2025-08-26 https://www.pureglobal.com/fr/news/swissmedic-launches-swissdamed-udi-playground 2025-12-02 https://www.pureglobal.com/fr/news/swissmedic-market-surveillance-results-2026-importer-focus-campaign 2026-02-06 https://www.pureglobal.com/fr/news/swissmedic-swissdamed-fees-2026-update-and-new-rules 2026-06-03 https://www.pureglobal.com/fr/news/swissmedic-swissdamed-registration-obligations-for-devices-2026 2026-03-31 https://www.pureglobal.com/fr/news/switzerland-2025-update-on-good-practices-for-endoscope-reprocessing 2025-09-16 https://www.pureglobal.com/fr/news/tga-f2026l01167-class-iia-saline-flush-cdss-exemption-2026 2026-09-09 https://www.pureglobal.com/fr/news/tga-medical-device-ivd-fees-annual-charges-2026 2026-07-01 https://www.pureglobal.com/fr/news/thailand-fda-2026-electronic-change-notification-system-for-medical-devices 2026-03-17 https://www.pureglobal.com/fr/news/thailand-medical-device-labeling-regulation-2025-key-updates 2026-03-12 https://www.pureglobal.com/fr/news/the-cost-of-non-compliance-in-medtech 2025-03-14 https://www.pureglobal.com/fr/news/the-shift-from-ivdd-to-ivdr-and-the-challenges 2025-03-14 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2025-12-27 https://www.pureglobal.com/fr/news/weekly-regulatory-news-11 2025-12-27 https://www.pureglobal.com/fr/news/weekly-regulatory-news-12 2025-12-27 https://www.pureglobal.com/fr/news/weekly-regulatory-news-13 2025-02-11 https://www.pureglobal.com/fr/news/weekly-regulatory-news-14 2025-12-27 https://www.pureglobal.com/fr/news/weekly-regulatory-news-15 2025-12-27 https://www.pureglobal.com/fr/news/weekly-regulatory-news-16 2025-12-27 https://www.pureglobal.com/fr/news/weekly-regulatory-news-17 2025-12-27 https://www.pureglobal.com/fr/news/weekly-regulatory-news-18 2025-12-27 https://www.pureglobal.com/fr/news/weekly-regulatory-news-19 2025-12-27 https://www.pureglobal.com/fr/news/weekly-regulatory-news-2 2025-04-30 https://www.pureglobal.com/fr/news/weekly-regulatory-news-20 2025-12-27 https://www.pureglobal.com/fr/news/weekly-regulatory-news-21 2025-12-27 https://www.pureglobal.com/fr/news/weekly-regulatory-news-22 2025-12-27 https://www.pureglobal.com/fr/news/weekly-regulatory-news-23 2025-12-27 https://www.pureglobal.com/fr/news/weekly-regulatory-news-24 2025-12-27 https://www.pureglobal.com/fr/news/weekly-regulatory-news-25 2025-12-27 https://www.pureglobal.com/fr/news/weekly-regulatory-news-26 2025-12-27 https://www.pureglobal.com/fr/news/weekly-regulatory-news-27 2025-12-27 https://www.pureglobal.com/fr/news/weekly-regulatory-news-28 2025-12-27 https://www.pureglobal.com/fr/news/weekly-regulatory-news-29 2025-12-27 https://www.pureglobal.com/fr/news/weekly-regulatory-news-3 2025-12-27 https://www.pureglobal.com/fr/news/weekly-regulatory-news-30 2025-12-27 https://www.pureglobal.com/fr/news/weekly-regulatory-news-31 2025-12-27 https://www.pureglobal.com/fr/news/weekly-regulatory-news-32 2025-12-27 https://www.pureglobal.com/fr/news/weekly-regulatory-news-33 2025-12-27 https://www.pureglobal.com/fr/news/weekly-regulatory-news-34 2025-12-27 https://www.pureglobal.com/fr/news/weekly-regulatory-news-35 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https://www.pureglobal.com/fr/resources/glossary 2026-07-24 https://www.pureglobal.com/fr/resources/news 2026-06-17 https://www.pureglobal.com/fr/resources/regulatory-updates 2026-09-10 https://www.pureglobal.com/fr/resources/videos 2026-06-17 https://www.pureglobal.com/fr/services/global-medical-device-registration 2026-07-28 https://www.pureglobal.com/fr/services/in-country-representation 2026-07-28 https://www.pureglobal.com/fr/services/market-access 2026-07-28 https://www.pureglobal.com/fr/services/medical-device-cybersecurity 2026-07-28 https://www.pureglobal.com/fr/services/medical-device-qms-consulting 2026-07-28 https://www.pureglobal.com/fr/services/medical-device-supplier-audits 2026-07-28 https://www.pureglobal.com/fr/services/pricing 2026-06-30 https://www.pureglobal.com/fr/videos/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/videos/brazils-udi-key-insights-for-medical-device-manufacturers 2025-08-01 https://www.pureglobal.com/fr/videos/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/videos/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/videos/eudamed-what-manufacturers-need-to-know-now 2025-07-17 https://www.pureglobal.com/fr/videos/global-expansion-strategies-for-medical-device-manufacturers-how-to-align-commercial-growth-with-regulatory-success 2025-07-25 https://www.pureglobal.com/fr/videos/how-to-get-medical-device-ce-marking-under-eu-mdr-a-step-by-step-guide 2025-08-08 https://www.pureglobal.com/fr/videos/how-to-register-a-medical-device-in-brazil 2025-07-21 https://www.pureglobal.com/fr/videos/how-to-register-a-medical-device-in-canada 2025-07-28 https://www.pureglobal.com/fr/videos/how-to-register-a-medical-device-in-china 2025-07-21 https://www.pureglobal.com/fr/videos/how-to-register-a-medical-device-in-hong-kong 2025-08-11 https://www.pureglobal.com/fr/videos/how-to-register-a-medical-device-in-indonesia 2025-08-11 https://www.pureglobal.com/fr/videos/how-to-register-a-medical-device-in-israel 2025-08-25 https://www.pureglobal.com/fr/videos/how-to-register-a-medical-device-in-japan 2025-08-08 https://www.pureglobal.com/fr/videos/how-to-register-a-medical-device-in-malaysia 2025-08-10 https://www.pureglobal.com/fr/videos/how-to-register-a-medical-device-in-singapore 2025-07-28 https://www.pureglobal.com/fr/videos/how-to-register-a-medical-device-in-thailand 2025-08-11 https://www.pureglobal.com/fr/videos/how-to-register-a-medical-device-in-the-philippines 2025-08-25 https://www.pureglobal.com/fr/videos/how-to-register-a-medical-device-in-the-uk 2025-08-11 https://www.pureglobal.com/fr/videos/how-to-register-a-medical-device-in-vietnam 2025-08-11 https://www.pureglobal.com/fr/videos/how-to-register-a-medical-device-with-invima-in-colombia 2025-07-21 https://www.pureglobal.com/fr/videos/how-to-register-a-medical-device-with-the-us-fda 2026-03-12 https://www.pureglobal.com/fr/videos/how-to-register-medical-device-in-saudi-arabia 2025-08-25 https://www.pureglobal.com/fr/videos/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/videos/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/videos/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/videos/mdcg-2025-5-explained-eu-ivdr-rules-for-ivd-performance-studies 2025-08-01 https://www.pureglobal.com/fr/videos/mexico-general-health-law Loi générale de santé du Mexique : guide vidéo https://www.pureglobal.com/assets/video-posters/dgX01chIlN4oUiAVheidWYONE01Waje9IuAV6CvpVEA6Y.jpg Voyez comment la Loi générale de santé du Mexique relie COFEPRIS, l'enregistrement et trois contrôles pratiques pour équipes de dispositifs médicaux. 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/videos/pure-globals-year-in-review-2025 2026-01-06 https://www.pureglobal.com/fr/videos/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/videos/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/videos/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/videos/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/videos/the-regulatory-changes-in-ivdr-and-its-implications-for-ivd-manufacturers 2025-07-21 https://www.pureglobal.com/fr/videos/understanding-mexicos-new-abbreviated-pathway 2025-08-25 https://www.pureglobal.com/glossary/anatel 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 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 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 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 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 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 2026-07-24 https://www.pureglobal.com/glossary/maude-database 2026-08-11 https://www.pureglobal.com/glossary/mdall 2026-08-11 https://www.pureglobal.com/glossary/mdsap 2026-07-27 https://www.pureglobal.com/glossary/medical-device-classification 2026-07-27 https://www.pureglobal.com/glossary/medical-device-reporting-mdr 2026-08-11 https://www.pureglobal.com/glossary/medical-device-technical-file 2026-07-27 https://www.pureglobal.com/glossary/medsafe 2026-07-24 https://www.pureglobal.com/glossary/medwatch 2026-08-11 https://www.pureglobal.com/glossary/mexico-general-health-law Mexico’s General Health Law, explained https://www.pureglobal.com/assets/video-posters/i02ImEwSW02j4BZC8ftyYGnSd7YPg3AiLP01wn8SKwgYME.jpg A 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 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 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 2026-07-24 https://www.pureglobal.com/glossary/what-is-the-artg 2026-07-24 https://www.pureglobal.com/glossary/what-is-the-therapeutic-goods-act-1989-australia 2026-07-27 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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 2026-07-24 https://www.pureglobal.com/it/glossary/notified-body 2026-08-11 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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 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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/videos/brazils-udi-key-insights-for-medical-device-manufacturers 2025-08-01 https://www.pureglobal.com/it/videos/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/videos/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/videos/eudamed-what-manufacturers-need-to-know-now 2025-07-17 https://www.pureglobal.com/it/videos/global-expansion-strategies-for-medical-device-manufacturers-how-to-align-commercial-growth-with-regulatory-success 2025-07-25 https://www.pureglobal.com/it/videos/how-to-get-medical-device-ce-marking-under-eu-mdr-a-step-by-step-guide 2025-08-08 https://www.pureglobal.com/it/videos/how-to-register-a-medical-device-in-brazil 2025-07-21 https://www.pureglobal.com/it/videos/how-to-register-a-medical-device-in-canada 2025-07-28 https://www.pureglobal.com/it/videos/how-to-register-a-medical-device-in-china 2025-07-21 https://www.pureglobal.com/it/videos/how-to-register-a-medical-device-in-hong-kong 2025-08-11 https://www.pureglobal.com/it/videos/how-to-register-a-medical-device-in-indonesia 2025-08-11 https://www.pureglobal.com/it/videos/how-to-register-a-medical-device-in-israel 2025-08-25 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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/videos/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/videos/mdcg-2025-5-explained-eu-ivdr-rules-for-ivd-performance-studies 2025-08-01 https://www.pureglobal.com/it/videos/mexico-general-health-law Legge Generale sulla Salute del Messico: videoguida https://www.pureglobal.com/assets/video-posters/fLXlzcQ48Xjw1602gOcGgni5IAlPHuez01IX01GyA019pm8.jpg Guarda come la Legge Generale sulla Salute del Messico si collega a COFEPRIS, alla registrazione dei dispositivi e a tre verifiche pratiche per i team. 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/videos/pure-globals-year-in-review-2025 2026-01-06 https://www.pureglobal.com/it/videos/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/videos/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 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https://www.pureglobal.com/ja/blog-posts/recall-management-a-necessary-evil-of-a-medical-device-companys-post-market-responsibilities 2025-08-14 https://www.pureglobal.com/ja/blog-posts/regulatory-requirements-and-challenges-for-new-and-old-class-d-devices-under-ivdr 2025-08-14 https://www.pureglobal.com/ja/blog-posts/research-report-ai-as-a-medical-device-global-market-access 2026-08-09 https://www.pureglobal.com/ja/blog-posts/research-report-asean-medtech-import-market 2025-08-20 https://www.pureglobal.com/ja/blog-posts/research-report-continuous-glucose-monitors-global-market-access 2026-07-06 https://www.pureglobal.com/ja/blog-posts/research-report-malaysias-medical-device-and-ivd-market 2025-08-20 https://www.pureglobal.com/ja/blog-posts/research-report-mexicos-medical-device-and-ivd-import-market 2025-08-20 https://www.pureglobal.com/ja/blog-posts/singapore-hsa-as-a-gateway-to-faster-device-registration-in-key-markets 2025-08-14 https://www.pureglobal.com/ja/blog-posts/supply-chain-requirements-for-economic-operators-under-the-eu-ivdr 2025-08-14 https://www.pureglobal.com/ja/blog-posts/surgical-robot-global-market-access-2026 2026-08-10 https://www.pureglobal.com/ja/blog-posts/thailands-medical-device-and-ivd-import-market 2025-09-16 https://www.pureglobal.com/ja/blog-posts/the-eu-parliament-votes-on-a-resolution-to-revise-specific-parts-of-the-mdr-and-ivdr 2025-08-14 https://www.pureglobal.com/ja/blog-posts/the-impact-of-ai-in-the-medtech-sector 2025-08-14 https://www.pureglobal.com/ja/blog-posts/transla-ai-simplifying-multi-language-documentation-for-global-medtech-companies 2025-02-26 https://www.pureglobal.com/ja/blog-posts/udi-us-eu-china-compliance-workorder-2026 2026-09-06 https://www.pureglobal.com/ja/blog-posts/understanding-reimbursement-related-payment-is-a-critical-piece-of-medical-device-market-access-strategy 2025-08-14 https://www.pureglobal.com/ja/blog-posts/untangling-the-regulations-of-health-tech 2025-08-14 https://www.pureglobal.com/ja/blog-posts/us-regulatory-insights-pure-global-collaboration 2025-08-14 https://www.pureglobal.com/ja/blog-posts/what-are-the-challenges-under-ivdr 2025-08-14 https://www.pureglobal.com/ja/blog-posts/why-and-how-eu-ivdr-compliance-matters-before-the-may-2025-deadline 2025-08-14 https://www.pureglobal.com/ja/blog-posts/wireless-compliance-for-medical-device-manufacturers-overview-of-radio-frequency-module-integration 2025-08-14 https://www.pureglobal.com/ja/case-studies 2026-08-10 https://www.pureglobal.com/ja/case-studies/anvisa-registration-class-iv-coronary-balloon-brazil 2026-08-11 https://www.pureglobal.com/ja/case-studies/anvisa-registration-single-use-endoscopes-brazil 2026-08-10 https://www.pureglobal.com/ja/case-studies/cofepris-ivd-registration-mexico 2026-08-10 https://www.pureglobal.com/ja/case-studies/eu-authorized-representative-medical-devices 2026-08-10 https://www.pureglobal.com/ja/case-studies/eu-mdr-class-iii-dermal-filler-registration 2026-08-11 https://www.pureglobal.com/ja/case-studies/eudamed-basic-udi-di-grouping-contrast-media-consumables 2026-08-11 https://www.pureglobal.com/ja/case-studies/invima-medical-device-registration-colombia 2026-08-10 https://www.pureglobal.com/ja/case-studies/vietnam-medical-device-registration 2026-08-10 https://www.pureglobal.com/ja/company/about 2026-07-12 https://www.pureglobal.com/ja/company/in-the-media 2026-07-12 https://www.pureglobal.com/ja/company/locations 2026-09-03 https://www.pureglobal.com/ja/company/our-team 2026-07-12 https://www.pureglobal.com/ja/contact 2026-06-30 https://www.pureglobal.com/ja/devices 2026-07-20 https://www.pureglobal.com/ja/devices/aesthetic-devices 2026-07-20 https://www.pureglobal.com/ja/devices/cardiovascular 2026-07-20 https://www.pureglobal.com/ja/devices/dental 2026-07-20 https://www.pureglobal.com/ja/devices/diabetes-care 2026-07-20 https://www.pureglobal.com/ja/devices/drug-delivery 2026-07-20 https://www.pureglobal.com/ja/devices/ent-audiology 2026-07-20 https://www.pureglobal.com/ja/devices/ivd 2026-07-20 https://www.pureglobal.com/ja/devices/medical-imaging 2026-07-20 https://www.pureglobal.com/ja/devices/neurotech 2026-07-20 https://www.pureglobal.com/ja/devices/ophthalmic 2026-07-20 https://www.pureglobal.com/ja/devices/orthopedics 2026-07-20 https://www.pureglobal.com/ja/devices/patient-care 2026-07-20 https://www.pureglobal.com/ja/devices/rehab-home 2026-07-20 https://www.pureglobal.com/ja/devices/samd 2026-07-20 https://www.pureglobal.com/ja/devices/surgery-robotics 2026-07-20 https://www.pureglobal.com/ja/devices/urology-womens-health 2026-07-20 https://www.pureglobal.com/ja/glossary/anatel 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 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 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 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 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 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 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 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。 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https://www.pureglobal.com/ja/videos/how-to-register-a-medical-device-in-malaysia 2025-08-10 https://www.pureglobal.com/ja/videos/how-to-register-a-medical-device-in-singapore 2025-07-28 https://www.pureglobal.com/ja/videos/how-to-register-a-medical-device-in-thailand 2025-08-11 https://www.pureglobal.com/ja/videos/how-to-register-a-medical-device-in-the-philippines 2025-08-25 https://www.pureglobal.com/ja/videos/how-to-register-a-medical-device-in-the-uk 2025-08-11 https://www.pureglobal.com/ja/videos/how-to-register-a-medical-device-in-vietnam 2025-08-11 https://www.pureglobal.com/ja/videos/how-to-register-a-medical-device-with-invima-in-colombia 2025-07-21 https://www.pureglobal.com/ja/videos/how-to-register-a-medical-device-with-the-us-fda 2026-03-12 https://www.pureglobal.com/ja/videos/how-to-register-medical-device-in-saudi-arabia 2025-08-25 https://www.pureglobal.com/ja/videos/invima INVIMA：コロンビア医療機器ロードマップ 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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/videos/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/videos/mdcg-2025-5-explained-eu-ivdr-rules-for-ivd-performance-studies 2025-08-01 https://www.pureglobal.com/ja/videos/mexico-general-health-law メキシコ一般保健法：動画ガイド https://www.pureglobal.com/assets/video-posters/5z2PNdrQFRpMx65GOjNCyc3TaYa101lEUa2iIWD00eeRY.jpg メキシコ一般保健法がCOFEPRISや医療機器登録とどのように関連しているか、医療機器チーム向けの実践的な3つの確認事項とともに動画でご覧いただけます。 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/videos/pure-globals-year-in-review-2025 2026-01-06 https://www.pureglobal.com/ja/videos/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/videos/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/videos/singapore-hsa シンガポールHSA：医療機器申請ルートの選定 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2026-07-20 https://www.pureglobal.com/ko/devices/surgery-robotics 2026-07-20 https://www.pureglobal.com/ko/devices/urology-womens-health 2026-07-20 https://www.pureglobal.com/ko/glossary/anatel 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 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 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 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 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 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 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 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 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 2026-07-24 https://www.pureglobal.com/ko/glossary/what-is-the-artg 2026-07-24 https://www.pureglobal.com/ko/glossary/what-is-the-therapeutic-goods-act-1989-australia 2026-07-27 https://www.pureglobal.com/ko/legal/cookie-policy 2026-06-17 https://www.pureglobal.com/ko/legal/privacy-policy 2026-06-17 https://www.pureglobal.com/ko/legal/terms-of-use 2026-06-17 https://www.pureglobal.com/ko/markets 2026-06-30 https://www.pureglobal.com/ko/markets/argentina 2026-07-24 https://www.pureglobal.com/ko/markets/australia 2026-07-24 https://www.pureglobal.com/ko/markets/bangladesh 2026-07-24 https://www.pureglobal.com/ko/markets/brazil 2026-07-24 https://www.pureglobal.com/ko/markets/brazil/ai-brazil-anvisa-submissions 2026-07-24 https://www.pureglobal.com/ko/markets/brazil/anvisa-medical-device-classification 2026-07-24 https://www.pureglobal.com/ko/markets/brazil/anvisa-medical-device-labeling 2026-07-24 https://www.pureglobal.com/ko/markets/brazil/anvisa-medical-device-postmarket-surveillance 2026-07-24 https://www.pureglobal.com/ko/markets/brazil/anvisa-medical-device-regulations 2026-07-24 https://www.pureglobal.com/ko/markets/canada 2026-07-24 https://www.pureglobal.com/ko/markets/china 2026-07-24 https://www.pureglobal.com/ko/markets/colombia 2026-07-24 https://www.pureglobal.com/ko/markets/colombia/invima-medical-device-classification 2026-07-24 https://www.pureglobal.com/ko/markets/colombia/invima-medical-device-labeling 2026-07-24 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https://www.pureglobal.com/ko/videos/how-to-register-a-medical-device-in-the-philippines 2025-08-25 https://www.pureglobal.com/ko/videos/how-to-register-a-medical-device-in-the-uk 2025-08-11 https://www.pureglobal.com/ko/videos/how-to-register-a-medical-device-in-vietnam 2025-08-11 https://www.pureglobal.com/ko/videos/how-to-register-a-medical-device-with-invima-in-colombia 2025-07-21 https://www.pureglobal.com/ko/videos/how-to-register-a-medical-device-with-the-us-fda 2026-03-12 https://www.pureglobal.com/ko/videos/how-to-register-medical-device-in-saudi-arabia 2025-08-25 https://www.pureglobal.com/ko/videos/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/videos/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/videos/japan-mhlw 일본 MHLW 및 PMDA: 기관별 역할 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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/videos/pure-globals-year-in-review-2025 2026-01-06 https://www.pureglobal.com/ko/videos/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/videos/saudi-sfda 사우디 SFDA: 의료기기 품목허가 및 현지 역할 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https://www.pureglobal.com/pt/case-studies/eudamed-basic-udi-di-grouping-contrast-media-consumables 2026-08-11 https://www.pureglobal.com/pt/case-studies/invima-medical-device-registration-colombia 2026-08-10 https://www.pureglobal.com/pt/case-studies/vietnam-medical-device-registration 2026-08-10 https://www.pureglobal.com/pt/company/about 2026-07-12 https://www.pureglobal.com/pt/company/in-the-media 2026-07-12 https://www.pureglobal.com/pt/company/locations 2026-09-03 https://www.pureglobal.com/pt/company/our-team 2026-07-12 https://www.pureglobal.com/pt/contact 2026-06-30 https://www.pureglobal.com/pt/devices 2026-07-20 https://www.pureglobal.com/pt/devices/aesthetic-devices 2026-07-20 https://www.pureglobal.com/pt/devices/cardiovascular 2026-07-20 https://www.pureglobal.com/pt/devices/dental 2026-07-20 https://www.pureglobal.com/pt/devices/diabetes-care 2026-07-20 https://www.pureglobal.com/pt/devices/drug-delivery 2026-07-20 https://www.pureglobal.com/pt/devices/ent-audiology 2026-07-20 https://www.pureglobal.com/pt/devices/ivd 2026-07-20 https://www.pureglobal.com/pt/devices/medical-imaging 2026-07-20 https://www.pureglobal.com/pt/devices/neurotech 2026-07-20 https://www.pureglobal.com/pt/devices/ophthalmic 2026-07-20 https://www.pureglobal.com/pt/devices/orthopedics 2026-07-20 https://www.pureglobal.com/pt/devices/patient-care 2026-07-20 https://www.pureglobal.com/pt/devices/rehab-home 2026-07-20 https://www.pureglobal.com/pt/devices/samd 2026-07-20 https://www.pureglobal.com/pt/devices/surgery-robotics 2026-07-20 https://www.pureglobal.com/pt/devices/urology-womens-health 2026-07-20 https://www.pureglobal.com/pt/glossary/anatel 2026-07-27 https://www.pureglobal.com/pt/glossary/anmat 2026-07-24 https://www.pureglobal.com/pt/glossary/anvisa ANVISA: O que equipes de dispositivos no Brasil devem saber https://www.pureglobal.com/assets/video-posters/Xae9e02Im02Q022AYXSH8laRcaj01yoFMZYNmJQJUJ47f1Y.jpg A ANVISA é a agência de vigilância sanitária do Brasil. 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https://www.pureglobal.com/pt/videos/mdcg-2025-5-explained-eu-ivdr-rules-for-ivd-performance-studies 2025-08-01 https://www.pureglobal.com/pt/videos/mexico-general-health-law Lei Geral de Saúde do México: Guia em Vídeo https://www.pureglobal.com/assets/video-posters/WZwBP7wW9GvsGPGb8N01KerYZHtvV9JRvnfHRpOOIaxk.jpg Veja como a Lei Geral de Saúde do México conecta COFEPRIS, registro de dispositivos e três verificações práticas para equipes de dispositivos médicos. 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/videos/pure-globals-year-in-review-2025 2026-01-06 https://www.pureglobal.com/pt/videos/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/videos/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/videos/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/videos/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/videos/the-regulatory-changes-in-ivdr-and-its-implications-for-ivd-manufacturers 2025-07-21 https://www.pureglobal.com/pt/videos/understanding-mexicos-new-abbreviated-pathway 2025-08-25 https://www.pureglobal.com/resources/blog 2026-09-06 https://www.pureglobal.com/resources/community 2026-06-17 https://www.pureglobal.com/resources/events 2026-06-17 https://www.pureglobal.com/resources/glossary 2026-07-24 https://www.pureglobal.com/resources/news 2026-06-17 https://www.pureglobal.com/resources/regulatory-updates 2026-09-10 https://www.pureglobal.com/resources/videos 2026-06-17 https://www.pureglobal.com/services/global-medical-device-registration 2026-07-28 https://www.pureglobal.com/services/in-country-representation 2026-07-28 https://www.pureglobal.com/services/market-access 2026-07-28 https://www.pureglobal.com/services/medical-device-cybersecurity 2026-07-28 https://www.pureglobal.com/services/medical-device-qms-consulting 2026-07-28 https://www.pureglobal.com/services/medical-device-supplier-audits 2026-07-28 https://www.pureglobal.com/services/pricing 2026-06-30 https://www.pureglobal.com/videos/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/videos/brazils-udi-key-insights-for-medical-device-manufacturers 2025-08-01 https://www.pureglobal.com/videos/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/videos/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/videos/eudamed-what-manufacturers-need-to-know-now 2025-07-17 https://www.pureglobal.com/videos/global-expansion-strategies-for-medical-device-manufacturers-how-to-align-commercial-growth-with-regulatory-success 2025-07-25 https://www.pureglobal.com/videos/how-to-get-medical-device-ce-marking-under-eu-mdr-a-step-by-step-guide 2025-08-08 https://www.pureglobal.com/videos/how-to-register-a-medical-device-in-brazil 2025-07-21 https://www.pureglobal.com/videos/how-to-register-a-medical-device-in-canada 2025-07-28 https://www.pureglobal.com/videos/how-to-register-a-medical-device-in-china 2025-07-21 https://www.pureglobal.com/videos/how-to-register-a-medical-device-in-hong-kong 2025-08-11 https://www.pureglobal.com/videos/how-to-register-a-medical-device-in-indonesia 2025-08-11 https://www.pureglobal.com/videos/how-to-register-a-medical-device-in-israel 2025-08-25 https://www.pureglobal.com/videos/how-to-register-a-medical-device-in-japan 2025-08-08 https://www.pureglobal.com/videos/how-to-register-a-medical-device-in-malaysia 2025-08-10 https://www.pureglobal.com/videos/how-to-register-a-medical-device-in-singapore 2025-07-28 https://www.pureglobal.com/videos/how-to-register-a-medical-device-in-thailand 2025-08-11 https://www.pureglobal.com/videos/how-to-register-a-medical-device-in-the-philippines 2025-08-25 https://www.pureglobal.com/videos/how-to-register-a-medical-device-in-the-uk 2025-08-11 https://www.pureglobal.com/videos/how-to-register-a-medical-device-in-vietnam 2025-08-11 https://www.pureglobal.com/videos/how-to-register-a-medical-device-with-invima-in-colombia 2025-07-21 https://www.pureglobal.com/videos/how-to-register-a-medical-device-with-the-us-fda 2026-03-12 https://www.pureglobal.com/videos/how-to-register-medical-device-in-saudi-arabia 2025-08-25 https://www.pureglobal.com/videos/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 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2026-06-17 https://www.pureglobal.com/zh/blog-posts/brazil-medical-device-market-statistics 2026-04-08 https://www.pureglobal.com/zh/blog-posts/brazils-medical-device-and-ivd-import-market 2025-09-08 https://www.pureglobal.com/zh/blog-posts/brazils-udi-system-nears-enforcement-what-medical-device-manufacturers-must-know-for-2025-and-beyond 2026-02-26 https://www.pureglobal.com/zh/blog-posts/changing-global-markets-brazil-navigating-new-regulatory-landscapes 2025-08-14 https://www.pureglobal.com/zh/blog-posts/clinical-evidence-under-ivdr-what-is-an-adequate-level-for-ivd-manufacturers 2025-08-14 https://www.pureglobal.com/zh/blog-posts/coronary-stent-global-market-access-2026 2026-08-17 https://www.pureglobal.com/zh/blog-posts/engaging-a-notified-body-under-the-ivdr-what-legacy-manufacturers-need-to-know-about-the-pre-application-process 2025-08-14 https://www.pureglobal.com/zh/blog-posts/how-the-eu-ivdr-opens-doors-beyond-the-eu 2025-08-14 https://www.pureglobal.com/zh/blog-posts/how-to-register-medical-devices-and-ivds-in-brazil 2026-07-09 https://www.pureglobal.com/zh/blog-posts/how-to-register-medical-devices-and-ivds-in-mexico 2026-06-17 https://www.pureglobal.com/zh/blog-posts/how-to-use-your-fda-and-eu-medical-device-approvals-to-access-25-markets 2026-06-02 https://www.pureglobal.com/zh/blog-posts/human-factors-in-medical-device-manufacturing 2025-08-14 https://www.pureglobal.com/zh/blog-posts/indonesias-medical-device-and-ivd-import-market 2026-01-12 https://www.pureglobal.com/zh/blog-posts/intended-purpose-for-ivds-and-impact-on-the-classification-under-ivdr 2025-08-14 https://www.pureglobal.com/zh/blog-posts/iso-10993-1-2025-global-transition-guide 2026-08-03 https://www.pureglobal.com/zh/blog-posts/ivd-global-market-access-2026 2026-07-27 https://www.pureglobal.com/zh/blog-posts/leveraging-medical-device-ce-marking-for-faster-entry-into-brazil 2025-10-22 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https://www.pureglobal.com/zh/blog-posts/orthopedic-implant-global-market-access-2026 2026-07-20 https://www.pureglobal.com/zh/blog-posts/partnering-with-pure-global-singapore 2025-08-14 https://www.pureglobal.com/zh/blog-posts/perspectives-on-using-outsourced-regulatory-services-vs-the-diy-approach 2025-08-14 https://www.pureglobal.com/zh/blog-posts/pure-global-2024-a-year-of-growth-innovation-and-global-impact 2025-02-26 https://www.pureglobal.com/zh/blog-posts/pure-global-regulatory-decisions-for-global-success 2025-07-29 https://www.pureglobal.com/zh/blog-posts/recall-management-a-necessary-evil-of-a-medical-device-companys-post-market-responsibilities 2025-08-14 https://www.pureglobal.com/zh/blog-posts/regulatory-requirements-and-challenges-for-new-and-old-class-d-devices-under-ivdr 2025-08-14 https://www.pureglobal.com/zh/blog-posts/research-report-ai-as-a-medical-device-global-market-access 2026-08-09 https://www.pureglobal.com/zh/blog-posts/research-report-asean-medtech-import-market 2025-08-20 https://www.pureglobal.com/zh/blog-posts/research-report-continuous-glucose-monitors-global-market-access 2026-07-06 https://www.pureglobal.com/zh/blog-posts/research-report-malaysias-medical-device-and-ivd-market 2025-08-20 https://www.pureglobal.com/zh/blog-posts/research-report-mexicos-medical-device-and-ivd-import-market 2025-08-20 https://www.pureglobal.com/zh/blog-posts/singapore-hsa-as-a-gateway-to-faster-device-registration-in-key-markets 2025-08-14 https://www.pureglobal.com/zh/blog-posts/supply-chain-requirements-for-economic-operators-under-the-eu-ivdr 2025-08-14 https://www.pureglobal.com/zh/blog-posts/surgical-robot-global-market-access-2026 2026-08-10 https://www.pureglobal.com/zh/blog-posts/thailands-medical-device-and-ivd-import-market 2025-09-16 https://www.pureglobal.com/zh/blog-posts/the-eu-parliament-votes-on-a-resolution-to-revise-specific-parts-of-the-mdr-and-ivdr 2025-08-14 https://www.pureglobal.com/zh/blog-posts/the-impact-of-ai-in-the-medtech-sector 2025-08-14 https://www.pureglobal.com/zh/blog-posts/transla-ai-simplifying-multi-language-documentation-for-global-medtech-companies 2025-02-26 https://www.pureglobal.com/zh/blog-posts/udi-us-eu-china-compliance-workorder-2026 2026-09-06 https://www.pureglobal.com/zh/blog-posts/understanding-reimbursement-related-payment-is-a-critical-piece-of-medical-device-market-access-strategy 2025-08-14 https://www.pureglobal.com/zh/blog-posts/untangling-the-regulations-of-health-tech 2025-08-14 https://www.pureglobal.com/zh/blog-posts/us-regulatory-insights-pure-global-collaboration 2025-08-14 https://www.pureglobal.com/zh/blog-posts/what-are-the-challenges-under-ivdr 2025-08-14 https://www.pureglobal.com/zh/blog-posts/why-and-how-eu-ivdr-compliance-matters-before-the-may-2025-deadline 2025-08-14 https://www.pureglobal.com/zh/blog-posts/wireless-compliance-for-medical-device-manufacturers-overview-of-radio-frequency-module-integration 2025-08-14 https://www.pureglobal.com/zh/case-studies 2026-08-10 https://www.pureglobal.com/zh/case-studies/anvisa-registration-class-iv-coronary-balloon-brazil 2026-08-11 https://www.pureglobal.com/zh/case-studies/anvisa-registration-single-use-endoscopes-brazil 2026-08-10 https://www.pureglobal.com/zh/case-studies/cofepris-ivd-registration-mexico 2026-08-10 https://www.pureglobal.com/zh/case-studies/eu-authorized-representative-medical-devices 2026-08-10 https://www.pureglobal.com/zh/case-studies/eu-mdr-class-iii-dermal-filler-registration 2026-08-11 https://www.pureglobal.com/zh/case-studies/eudamed-basic-udi-di-grouping-contrast-media-consumables 2026-08-11 https://www.pureglobal.com/zh/case-studies/invima-medical-device-registration-colombia 2026-08-10 https://www.pureglobal.com/zh/case-studies/vietnam-medical-device-registration 2026-08-10 https://www.pureglobal.com/zh/company/about 2026-07-12 https://www.pureglobal.com/zh/company/in-the-media 2026-07-12 https://www.pureglobal.com/zh/company/locations 2026-09-03 https://www.pureglobal.com/zh/company/our-team 2026-07-12 https://www.pureglobal.com/zh/contact 2026-06-30 https://www.pureglobal.com/zh/devices 2026-07-20 https://www.pureglobal.com/zh/devices/aesthetic-devices 2026-07-20 https://www.pureglobal.com/zh/devices/cardiovascular 2026-07-20 https://www.pureglobal.com/zh/devices/dental 2026-07-20 https://www.pureglobal.com/zh/devices/diabetes-care 2026-07-20 https://www.pureglobal.com/zh/devices/drug-delivery 2026-07-20 https://www.pureglobal.com/zh/devices/ent-audiology 2026-07-20 https://www.pureglobal.com/zh/devices/ivd 2026-07-20 https://www.pureglobal.com/zh/devices/medical-imaging 2026-07-20 https://www.pureglobal.com/zh/devices/neurotech 2026-07-20 https://www.pureglobal.com/zh/devices/ophthalmic 2026-07-20 https://www.pureglobal.com/zh/devices/orthopedics 2026-07-20 https://www.pureglobal.com/zh/devices/patient-care 2026-07-20 https://www.pureglobal.com/zh/devices/rehab-home 2026-07-20 https://www.pureglobal.com/zh/devices/samd 2026-07-20 https://www.pureglobal.com/zh/devices/surgery-robotics 2026-07-20 https://www.pureglobal.com/zh/devices/urology-womens-health 2026-07-20 https://www.pureglobal.com/zh/glossary/anatel 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 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 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 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 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。 https://stream.mux.com/3u57zMukJrNPLQWPGJEdaTq17Hwj00mqHR715u5t016qY.m3u8 https://player.mux.com/3u57zMukJrNPLQWPGJEdaTq17Hwj00mqHR715u5t016qY?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F3u57zMukJrNPLQWPGJEdaTq17Hwj00mqHR715u5t016qY.jpg&accent-color=%232451c6 124 2026-09-11T19:55:40.171Z 2026-09-11 https://www.pureglobal.com/zh/glossary/iso-17665 2026-07-27 https://www.pureglobal.com/zh/glossary/iso-20417 2026-07-27 https://www.pureglobal.com/zh/glossary/israel-amar 2026-07-24 https://www.pureglobal.com/zh/glossary/japan-mhlw 日本MHLW与PMDA分工 https://www.pureglobal.com/assets/video-posters/U15jTq8oUzCKD01mFUIQk6j8JdBAK78imVvOIh2Z45fg.jpg MHLW是日本厚生劳动省，拥有医疗器械审批的行政权力。 https://stream.mux.com/U15jTq8oUzCKD01mFUIQk6j8JdBAK78imVvOIh2Z45fg.m3u8 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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 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 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https://www.pureglobal.com/zh/resources/glossary 2026-07-24 https://www.pureglobal.com/zh/resources/news 2026-06-17 https://www.pureglobal.com/zh/resources/regulatory-updates 2026-09-10 https://www.pureglobal.com/zh/resources/videos 2026-06-17 https://www.pureglobal.com/zh/services/global-medical-device-registration 2026-07-28 https://www.pureglobal.com/zh/services/in-country-representation 2026-07-28 https://www.pureglobal.com/zh/services/market-access 2026-07-28 https://www.pureglobal.com/zh/services/medical-device-cybersecurity 2026-07-28 https://www.pureglobal.com/zh/services/medical-device-qms-consulting 2026-07-28 https://www.pureglobal.com/zh/services/medical-device-supplier-audits 2026-07-28 https://www.pureglobal.com/zh/services/pricing 2026-06-30 https://www.pureglobal.com/zh/videos/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。 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2026-09-11T19:53:34.072Z 2026-09-11 https://www.pureglobal.com/zh/videos/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/videos/eudamed-what-manufacturers-need-to-know-now 2025-07-17 https://www.pureglobal.com/zh/videos/global-expansion-strategies-for-medical-device-manufacturers-how-to-align-commercial-growth-with-regulatory-success 2025-07-25 https://www.pureglobal.com/zh/videos/how-to-get-medical-device-ce-marking-under-eu-mdr-a-step-by-step-guide 2025-08-08 https://www.pureglobal.com/zh/videos/how-to-register-a-medical-device-in-brazil 2025-07-21 https://www.pureglobal.com/zh/videos/how-to-register-a-medical-device-in-canada 2025-07-28 https://www.pureglobal.com/zh/videos/how-to-register-a-medical-device-in-china 2025-07-21 https://www.pureglobal.com/zh/videos/how-to-register-a-medical-device-in-hong-kong 2025-08-11 https://www.pureglobal.com/zh/videos/how-to-register-a-medical-device-in-indonesia 2025-08-11 https://www.pureglobal.com/zh/videos/how-to-register-a-medical-device-in-israel 2025-08-25 https://www.pureglobal.com/zh/videos/how-to-register-a-medical-device-in-japan 2025-08-08 https://www.pureglobal.com/zh/videos/how-to-register-a-medical-device-in-malaysia 2025-08-10 https://www.pureglobal.com/zh/videos/how-to-register-a-medical-device-in-singapore 2025-07-28 https://www.pureglobal.com/zh/videos/how-to-register-a-medical-device-in-thailand 2025-08-11 https://www.pureglobal.com/zh/videos/how-to-register-a-medical-device-in-the-philippines 2025-08-25 https://www.pureglobal.com/zh/videos/how-to-register-a-medical-device-in-the-uk 2025-08-11 https://www.pureglobal.com/zh/videos/how-to-register-a-medical-device-in-vietnam 2025-08-11 https://www.pureglobal.com/zh/videos/how-to-register-a-medical-device-with-invima-in-colombia 2025-07-21 https://www.pureglobal.com/zh/videos/how-to-register-a-medical-device-with-the-us-fda 2026-03-12 https://www.pureglobal.com/zh/videos/how-to-register-medical-device-in-saudi-arabia 2025-08-25 https://www.pureglobal.com/zh/videos/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/videos/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。 https://stream.mux.com/3u57zMukJrNPLQWPGJEdaTq17Hwj00mqHR715u5t016qY.m3u8 https://player.mux.com/3u57zMukJrNPLQWPGJEdaTq17Hwj00mqHR715u5t016qY?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2F3u57zMukJrNPLQWPGJEdaTq17Hwj00mqHR715u5t016qY.jpg&accent-color=%232451c6 124 2026-09-11T19:55:40.171Z 2026-09-11 https://www.pureglobal.com/zh/videos/japan-mhlw 日本MHLW与PMDA分工 https://www.pureglobal.com/assets/video-posters/U15jTq8oUzCKD01mFUIQk6j8JdBAK78imVvOIh2Z45fg.jpg MHLW是日本厚生劳动省，拥有医疗器械审批的行政权力。 https://stream.mux.com/U15jTq8oUzCKD01mFUIQk6j8JdBAK78imVvOIh2Z45fg.m3u8 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/videos/mdcg-2025-5-explained-eu-ivdr-rules-for-ivd-performance-studies 2025-08-01 https://www.pureglobal.com/zh/videos/mexico-general-health-law 墨西哥《卫生总法》：视频指南 https://www.pureglobal.com/assets/video-posters/9X9FJ00iQZnWlIAUPr7tiCrBS01v02kBvSPNUsb5JPXs2w.jpg 观看视频，了解墨西哥《卫生总法》如何与COFEPRIS及医疗器械注册相衔接，以及面向医疗器械团队的3项实用核查。 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/videos/pure-globals-year-in-review-2025 2026-01-06 https://www.pureglobal.com/zh/videos/rdc-751-2022 巴西RDC 751：分类、注册卷宗与标签 https://www.pureglobal.com/assets/video-posters/q4ww5vlLFl8v5BlkbK1f4HaLy01nNGcdufxRyxcMtkfs.jpg 该决议于二零二三年三月正式生效。 https://stream.mux.com/q4ww5vlLFl8v5BlkbK1f4HaLy01nNGcdufxRyxcMtkfs.m3u8 https://player.mux.com/q4ww5vlLFl8v5BlkbK1f4HaLy01nNGcdufxRyxcMtkfs?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2Fq4ww5vlLFl8v5BlkbK1f4HaLy01nNGcdufxRyxcMtkfs.jpg&accent-color=%232451c6 131 2026-09-11T20:04:11.570Z 2026-09-11 https://www.pureglobal.com/zh/videos/saudi-sfda 沙特 SFDA：医疗器械准入与本地角色 https://www.pureglobal.com/assets/video-posters/Fduso6CZu7q3IEBKAUVrZBuKslWZ3dd01SqF2oOr8Y6g.jpg 沙特食品药品管理局负责监管医疗器械与体外诊断试剂。 https://stream.mux.com/Fduso6CZu7q3IEBKAUVrZBuKslWZ3dd01SqF2oOr8Y6g.m3u8 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/videos/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/videos/thailand-fda 泰国FDA：医疗器械上市实用清单 https://www.pureglobal.com/assets/video-posters/ZRpFfj9WOt53UU36eqjIJZYUGW8Lk0000sW2wUcZaU3m8.jpg 隶属于公共卫生部的泰国FDA负责监管健康产品。 https://stream.mux.com/ZRpFfj9WOt53UU36eqjIJZYUGW8Lk0000sW2wUcZaU3m8.m3u8 https://player.mux.com/ZRpFfj9WOt53UU36eqjIJZYUGW8Lk0000sW2wUcZaU3m8?preload=none&stream-type=on-demand&poster=https%3A%2F%2Fwww.pureglobal.com%2Fassets%2Fvideo-posters%2FZRpFfj9WOt53UU36eqjIJZYUGW8Lk0000sW2wUcZaU3m8.jpg&accent-color=%232451c6 117 2026-09-11T19:51:34.303Z 2026-09-11 https://www.pureglobal.com/zh/videos/the-regulatory-changes-in-ivdr-and-its-implications-for-ivd-manufacturers 2025-07-21 https://www.pureglobal.com/zh/videos/understanding-mexicos-new-abbreviated-pathway 2025-08-25