APEC Regulatory Harmonization Steering Committee (RHSC)
Results
Working group
Review and update the GHTF/SG1/N045:2008 Principles of In Vitro Diagnostic (IVD) Medical Devices Classification.
Consultation
Principles of In Vitro Diagnostic (IVD) Medical Devices Classification, Principles of In Vitro Diagnostic (IVD) Medical Devices Classification Working Group, Coordinator Tatyana Buryakina, Closed 25 July 2020.
Consultation
Medical Devices: Post Market Surveillance: National Competent Authority Report Exchange Criteria and Report Form, A review of the NCAR system Working Group, Coordinator Jean-Francois Roche
European Commission, Closed Monday, 8 December 2014.
Working group
A working group for Clinical Evidence for IVD Medical Devices
Consultation
UDI System for Medical Devices, Unique Device Identification (UDI) Application Guide Working Group, Coordinator Salvatore Scalzo - European Commission, Closed Saturday, 31 August 2013.
Page
IMDRF-developed or IMDRF-sponsored training materials and events supporting Regulatory Authorities (RA), medical device industry and other stakeholders in understanding and implementing IMDRF technical documents
Working group
Manage cybersecurity risks in medical devices through a life-cycle approach. Striking the right balance between pre-market and post-market requirements.
Consultation
Assessment and Decision Process for the Recognition of a Conformity Assessment Body Conducting Medical Device Regulatory Reviews, Good Regulatory Review Practices Working Group, Coordinator Melissa Torres, Closed date 19 April 2021.
Consultation
Requirements for Regulatory Authority Recognition of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews, Good Regulatory Review Practices Working Group, Closed 3 October 2019.