Southeast Asia

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…

The Medical Device Regulatory Convergence Project (MDRC) held the Webinar on Conformity Assessment for Medical Devices – Personalized Medical Devices on 6 and 7 February. The Webinar had approximately 20 officials attend the two-day session, which focused on conformity assessment and personalized medical devices; the latter topic was included at MOH’s request. The MDRC team also…

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…

The Medical Device Regulatory Convergence Project co-lead by USAID, ANSI, and AdvaMed in collaboration with the Ministry of Health of Indonesia organized a training on International References and Standards on Quality Management System – MDSAP, Artificial Intelligence and Software as Medical Device (SaMD), Clinical Evaluation, Electrical Safety and Performance, and Post-market Surveillance of Medical Devices…

The Medical Device Regulatory Convergence Project co-lead by USAID, ANSI, and AdvaMed in collaboration with the Ministry of Health of Indonesia and Gadjah Mada University organized a Webinar series on Good Regulatory Practices, focused on the World Trade Organization’s (WTO) Technical Barriers to Trade (TBT) agreement and legal obligations as it relates to GRPs and…