Breadcrumb Home Documents Documents IMDRF documents support regulatory harmonization and convergence of IMDRF List of links to various types of documents Technical documents Final documents produced by a working group GHTF final documents Final documents created by the Global Harmonization Task force (GHTF) that are still current. Procedural documents Operational planning and guidance Information documents Reference material for IMDRF members Meeting outcome statements Official meeting summaries including MC decisions GHTF archives Historical information and archived documents produced by the Global Harmonization Task Force (GHTF) Latest technical documents IMDRF/Standards WG/N72 IMDRF Standards Liaison Program Framework 13 May 2022 IMDRF/AIMD WG/N67 Machine Learning-enabled Medical Devices: Key Terms and Definitions 9 May 2022 IMDRF/NCAR WG/N14 Medical Devices: Post-Market Surveillance: National Competent Authority Report Exchange Criteria and Report Form 5 May 2022 IMDRF/MDSAP WG/N4 Competence and Training Requirements for Auditing Organizations 20 October 2021 View all technical documents Meeting outcome statements Meeting no: 21Australia Virtual Meeting outcome statement14 June 2022 Meeting no: 20Korea Virtual Meeting outcome statement19 November 2021 Meeting no: 19Korea Virtual Meeting outcome statement25 March 2021 Meeting no: 18Singapore Virtual Meeting outcome statement25 September 2020 Meeting no: 17Closed session management committee meeting outcome statement18 March 2020 Meeting no: 16Russia Yekaterinburg meeting outcome statement19 September 2019 View all outcome statements
IMDRF/NCAR WG/N14 Medical Devices: Post-Market Surveillance: National Competent Authority Report Exchange Criteria and Report Form 5 May 2022