Policy Sessions:
The Coalition held a series of educational webinars to provide the policy context for Medical Device Regulatory Convergence. Topics included:
- Medical Device International Benchmarks: WHO, IMDRF, MDSAP
- Good Regulatory Practices (GRP)
- Technical Barriers to Trade (TBT)
- International Standards and Conformity Assessment System
- International Medical Device Standardization
Webinar Session 1 – May 26, 2020
Regulatory Convergence and International Benchmarks: WHO, IMDRF, MDSAP. Agenda, Slides deck, Webinar Recording.
Webinar Session 2 – June 2, 2020
Global Perspectives: GMTA, MDUFA, 21st Century Cures, APEC MD Initiative, GRPs and International Benchmarks: OECD, IDB, ABD, APEC & Advancing Opportunities from the COVID-19 Pandemic.
Agenda, Slides deck, Webinar Recording.
Webinar Session 3 – June 9, 2020
World Trade Organization and TBT Agreement as GRP, International Standards And Conformity Assessment as GRP, International Standards and SDOs for Medical Technology & National Standard Bodies.
Agenda, Slides deck, Webinar Recording.
This policy series was followed by a webinar session from the U.S. FDA as part of the Coalition Regulator Series.
