The Medical Device Regulatory Convergence Project (MDRC) held two Small Group Sessions with Indonesian MOH officials, the first on 7 December 2022 and the second on 6 and 7 February. The event, in partnership with the Ministry of Health, Indonesia, had the purpose to provide opportunity for two-way interaction between international experts and MOH officials on alignment and implementation of QMS measures and international good regulatory practices (GRPs) to ease regulatory burden on MOH. For the first session, approximately 20 officials attended the two-hour workshop, which focused on contextualizing and implementing fundamental GRPs and QMS methods. Speakers included representatives from the Medical Devices Directorate, Health Canada and from the Medical Device Single Audit Program (MDSAP), TUV.
Recap Foundational GRPs
Good Regulatory Practices (GRP) and Technical Barriers to Trade (TBT) – Renata Amaral
Introduction to QMS Topic
Regulatory Oversight of Manufacturing Quality in the Medical Device Industry – Frederic Hamelin – Health Canada, Dawn Tibodeau – TÜV SÜD America