APEC Regulatory Harmonization Steering Committee (RHSC)
Results
Consultation
Recognition and monitoring of organizations undertaking audits of medical device manufacturers, Medical device single audit program (MDSAP) Working Group, Coordinator Kimberly Trautman - US Food and Drug Administration (FDA), Closed Friday, 14 June 2013.
Consultation
Recognition Criteria for Medical Device Auditing Organizations, Medical device single audit program (MDSAP) Working Group, Coordinator Kimberly Trautman - US Food and Drug Administration (FDA), Closed Friday, 14 December 2012.
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
Tools for Assessing the Usability of Registries in Support of Regulatory Decision Making, Integrating patient registries and innovative tools for enhanced medical device evaluation and tracking Working Group, Coordinator Danica Marinac-Dabic, Closed 1 December 2017.
Consultation
Methodological Principles in the Use of International Medical Device Registry Data, Integrating patient registries and innovative tools for enhanced medical device evaluation and tracking Working Group, Coordinator Danica Marinac-Dabic,US Food and Drug Administration (FDA), Closed Friday, 2 December 2016.
Consultation
Patient Registry: Essential Principles, Integrating patient registries and innovative tools for enhanced medical device evaluation and tracking Working Group, Coordinator Danica Marinac-Dabic -
US Food and Drug Administration (FDA) , Closed Saturday, 16 January 2016.
Consultation
Personalized Medical Devices - Regulatory Pathways, Personalized Medical Devices (PMD) Working Group, Coordinator Tracey Duffy, Closed 24 July 2019.
Consultation
Definitions for Personalized Medical Devices, Personalized Medical Devices (PMD) Working Group, Coordinator Tracey Duffy, Closed 24 May 2018.
Consultation
RPS Table of Contents Pilot, Regulated Product Submission Working Group, Coordinator Patrick Axtell
US Food and Drug Administration (FDA), Closed Tuesday, 20 March 2018.
Consultation
RPS - Common Data Elements for Medical Device Identification, Regulated Product Submission Working Group, Coordinator Nancy Shadeed, Closed 15 September 2015.