The Medical Device Regulatory Convergence Project (MDRC) co-lead by USAID, ANSI, and AdvaMed conducted the virtual Regional Workshop on Good Regulatory Practices (GRPs) and Medical Devices Regulation on 28 February and 1 March 2023.
The workshop featured discussions the World Trade Organization’s (WTO) Technical Barriers to Trade (TBT) agreement and legal obligations as it relates to GRPs and national commitments, assessment of safety and performance of medical devices; regulatory reliance models for medical device assessment; and post-market surveillance.
Representatives from National Standards Organizations in ASEAN, the ASEAN Medical Device Committee, private sector and industry associations, and the U.S. government joined the workshop.
Karl Fickenscher, Senior Deputy Assistant Administrator, Bureau for Development, Democracy, and Innovation, USAID, and Mohd Asni Abd Ghani, Vice-Chair of the ASEAN Medical Device Committee, delivered key remarks.
Agenda
Recordings
Day 1
Day 2
Use and Contextualization of Reliance Models to Streamline Medical Device Assessment – Neil Mafnas
Presentations
Day 1
Overview of International Good Regulatory Practices and Standards
TBT Agreement and medical device regulation – Devin McDaniels, Deputy Secretary
Good Regulatory Practice – Renee Hancher, Director
Global Frameworks for Regulation of Medical Devices
WHO GLOBAL MODEL REGULATORY FRAMEWORK FOR MEDICAL DEVICES INCLUDING IVDs (GMRF) – Agnes Sitta Kijo, Technical Officer
Foundational Principles & Regulatory Convergence – Tammy Steuerwald, Global Head of Regulatory Policy
Day 2
Use and Contextualization of Reliance Models to Streamline Medical Device Assessment
US Food and Drug Administration – Neil Mafnas, Center for Devices and Radiological Health
Health Sciences Authority – Wong Woei Jiuang, Assistant Group Director
Post-Market Surveillance – Regulators’ Role and Private Sector Stakeholder Perspectives
On Post-Market Surveillance and Market Vigilance – Anita Sands, Technical Officer
International Medical Device Regulator Forum (IMDRF) Adverse Event Terminology – Lailing Liew, Regulatory Consultant
