APEC Regulatory Harmonization Steering Committee (RHSC)
Results
Procedural document
IMDRF/MC/N2
Procedural document: IMDRF/MC/N2
Published date
Article
From May 2025, all IMDRF related forms will be available online from IMDRF’s Citizen Space site.
Procedural document
IMDRF/MC/N1
Procedural document: IMDRF/MC/N1 FINAL:2024 (Edition 7)
Published date
Information document
IMDRF/NCAR WG/N14 FINAL:2025 (Edition 5)
Medical Devices: Post-Market Surveillance: National Competent Authority Report Exchange Criteria and Report Form
Published date
Outcome statement
IMDRF 27th MC Meeting Tokyo, Japan March 2025 - Outcome Statement
Published date
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