APEC Regulatory Harmonization Steering Committee (RHSC)
Results
Consultation
Competence, Training and Conduct Requirements for Regulatory Reviewers, Good Regulatory Review Practices Working Group, Coordinator Melissa Torres - US Food and Drug Administration (FDA), Closed Friday, 14 October 2016.
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
Proposed update to document on Post-Market Clinical Follow-Up Studies, Medical Device Clinical Evaluation Working Group, Coordinator Dr Yinghui Liu, Closed 11 December 2020.
Consultation
Proposed update to Clinical Evaluation documents, Medical Device Clinical Evaluation Working Group, Coordinator Dr Yinghui Liu - Center for Medical Device Evaluation (CMDE), Closed Wednesday, 5 June 2019.
Consultation
MDSAP - Guidance on Regulatory Authority Assessment Methods of Auditing Organization's Processes, Medical device single audit program (MDSAP) Working Group, Coordinator Kimberly Trautman MSc, Closed 1 June 2015.
Consultation
MDSAP - Medical Device Regulatory Audit Reports, Medical device single audit program (MDSAP) Working Group, Coordinator Kimberly Trautman MSc, Closed 1 June 2015.
Consultation
MDSAP Assessment Outcomes and Recognition/Re-recognition Decision by Regulatory Authorities, Medical device single audit program (MDSAP) Working Group, Coordinator Kimberly Trautman - US Food and Drug Administration (FDA), Closed Saturday, 31 May 2014.
Consultation
Assessor competency and training requirements for Regulatory Authorities undertaking assessments of auditing organizations, Medical device single audit program (MDSAP) Working Group, Coordinator Kimberly Trautman - US Food and Drug Administration (FDA), Closed Friday, 30 August 2013.
Consultation
Regulatory Assessment Program and Assessment Strategy utilizing for the recognition and monitoring of medical device auditing organizations, Medical device single audit program (MDSAP) Working Group, Coordinator Kimberly Trautman - US Food and Drug Administration (FDA), Closed Friday, 30 August 2013.
Consultation
Auditor competency and training requirements for 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.