Southeast Asia - Standards Alliance Phase 2 COVID-19 Medical Device Regulatory Convergence Project (MDRC)

MDRC Overview Presentation Southeast Asia

In Southeast Asia, MDRC works to strengthen resilience for future health crises, invest in global medical device regulatory infrastructure, and build capacity in medical device regulatory agencies in project countries. The project countries are: Viet Nam, Thailand, and Indonesia. The importance of these project countries within their respective regions and sub-regions will facilitate additional project benefits in the surrounding regions including with Malaysia. MDRC’s regional objectives in Southeast Asia are:

Foster implementation of foundational GRPs that promote good governance in the regulatory process, focusing on transparency, predictability and accountability;

Foster implementation of medical device sector-specific convergence in regulations, standards, and conformity assessment;

Assist customs authorities in understanding and following the import criteria and policies set by the health authorities addressing COVID-19.