APEC Regulatory Harmonization Steering Committee (RHSC)
Results
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.
Consultation
UDI System for Medical Devices, Unique Device Identification (UDI) Application Guide Working Group, Coordinator Salvatore Scalzo - European Commission, Closed Saturday, 31 August 2013.
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.
Consultation
Regulatory Authority Assessment Method for Recognition and Surveillance of Medical Device Conformity Assessment Bodies, Good Regulatory Review Practices Working Group, Coordinator Melissa Torres, Closed 9 May 2020.
Consultation
Competence and Training Requirements for Regulatory Authority Assessors of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews, Good Regulatory Review Practices Working Group, Closed 26 May 2020.
Consultation
A Proposed Document by the International Medical Device Regulators Forum (IMDRF) Good Regulatory Review Practices Working Group is provided below for public comment.
Consultation
Principles and Practices for Software Bill of Materials (SBOM) for Medical Device Cybersecurity - Good Regulatory Review Practices, Coordinator Dr Aftin Ross
Consultation
IMDRF Principles and Practices for Medical Device Cybersecurity, Medical Device Cybersecurity Guide Working Group, Coordinator Suzanne Schwartz, Closed 2 December 2019.
Consultation
Guiding Principles to Support Medical Device Health Equity (N79)