APEC Regulatory Harmonization Steering Committee (RHSC)
Results
Article
Reminder: The current consultation on IMDRF/CEIVD WG/N91 Draft: 2026 – Clinical Evidence for IVD Medical Devices: Definitions and Principles of Performance Evaluation will close on 5 May 2026.
Technical document
IMDRF/AE WG/N43
Technical document: IMDRF/AE WG/N43FINAL:2020 (Edition 4) - Annexes and release notes updated annually
Current Annexes and Appendix release: IMDRF/AE WG/N43FINAL:2025
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Information document
IMDRF/NCAR WG/N14 FINAL:2025 (Edition 5)
Medical Devices: Post-Market Surveillance: National Competent Authority Report Exchange Criteria and Report Form
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Article
Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices: Workshop record available fthrough GRRP Working Group
Technical document
IMDRF/GRRP WG/N52 FINAL:2024 (Edition 2)
Technical document: IMDRF/GRRP WG/N52 FINAL:2024 (Edition 2)
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Technical document
IMDRF/GRRP WG/N47 FINAL:2024 (Edition 2)
Technical document: IMDRF/GRRP WG/N47 FINAL:2024 (Edition 2)
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Technical document
IMDRF/PMD WG/N58:2023 (Edition 2)
Technical document: IMDRF/PMD WG/N58 FINAL:2023 (Edition 2)
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Technical document
IMDRF/PMD WG/N74
Personalized Medical Devices – Production Verification and Validation (N74)
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Technical document
IMDRF/CYBER WG/N70
Principles and Practices for the Cybersecurity of Legacy Medical Devices (N70) Final
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