APEC Regulatory Harmonization Steering Committee (RHSC)
Results
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
Information document
IMDRF/MC/N87
IMDRF 26th Session Workshop - White Paper on Developing a Regulatory Framework
Published date
Technical document
IMDRF/AET WG/N85 FINAL: 2024
Common Data Set for Adverse Event Data Exchange Between IMDRF Regulators
Published date
Outcome statement
MDRF 26th MC Meeting Seattle, Washington September 2024 - Outcome Statement
Published date
Information document
IMDRF/MC/N84
IMDRF Document Implementation Report
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