APEC Regulatory Harmonization Steering Committee (RHSC)
Results
Article
Global Harmonization Working Party (GHWP) has voluntarily withdrawn from IMDRF.
Article
From May 2025, all IMDRF related forms will be available online from IMDRF’s Citizen Space site.
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
Published date
Technical document
IMDRF/SaMD WG/N81 FINAL:2025
Characterization Considerations for Medical Device Software and Software-Specific Risk
Published date
Technical document
IMDRF/AIML WG/N88 FINAL:2025
Good machine learning practice for medical device development: Guiding principles
Published date
Article
Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices: Workshop record available fthrough GRRP Working Group
Technical document
IMDRF/AET WG/N85 FINAL: 2024
Common Data Set for Adverse Event Data Exchange Between IMDRF Regulators
Published date
Technical document
IMDRF/RPS WG/N9 Final:2024 (Edition 4)
IMDRF/RPS WG/N9 Final:2024 (Edition 4)
Published date
Technical document
IMDRF/RPS WG/N13 Final:2024 (Edition 4)
Technical document: IMDRF/RPS WG/N13 FINAL:2024 (Edition 4)
Published date
Technical document
IMDRF/GRRP WG/N66 FINAL:2024 (Edition 2)
Technical document IMDRF/GRRP WG/N66 FINAL:2024 (Edition 2)
Published date