ASEAN Medical Device Regulatory Integration

Navigating global regulatory markets can be a challenge, particularly when multiple countries in a region differ in their rules. Playing by a common set of rules for medtech regulation is about to get a little easier in Southeast Asia, as a group of countries prepares to unveil a more unified approach to oversight.

The Association of Southeast Asian Nations (ASEAN) is a political and economic grouping of ten countries making up all of Southeast Asia: Indonesia, Singapore,Malaysia, the Philippines, Thailand, Brunei, Cambodia, Vietnam, Laos, and Myanmar. ASEAN has a combined population of about 600 million people and a combined GDP of about $2.6 trillion (adjusted for purchasing power parity). By comparison, the EU has 500 million people and a $14.7 trillion GDP, and Japan has 125 million people and a $4.3 trillion GDP.