APEC Regulatory Harmonization Steering Committee (RHSC)
Results
Procedural document
IMDRF/MC/N91 FINAL:2025
The strategic plan outlines the mission, objectives and priorities of the International Medical Device Regulators Forum (IMDRF).
Published date
Article
Global Harmonization Working Party (GHWP) has voluntarily withdrawn from IMDRF.
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
Article
Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices: Workshop record available fthrough GRRP Working Group
Procedural document
IMDRF/MC/N83 FINAL: 2024
Slide Template (MS PowerPoint) to assist in the development of presentations by Regulatory Authorities making IMDRF Membership Applications
Published date
Procedural document
FOR GUIDANCE ONLY - IMDRF/MC/N69 FINAL:2023 (Edition 8)
FOR GUIDANCE ONLY: IMDRF/MC/N69 FINAL:2023 (Edition 8)
Published date
Procedural document
IMDRF/MC/N75 FINAL:2023 (Edition 2)
IMDRF Working Group Membership Application Form
Published date
Article
IMDRF Working Group Updates to the 24th IMDRF MC Session available for review and feedback