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One Audit, Six Markets? MDSAP vs. ISO 13485 in Southeast Asia
We explore the Quality Management System requirements for medical device manufacturers in six key Southeast Asian markets: Singapore, Malaysia, Vietnam, the Philippines, Thailand, and Indonesia. The episode details the mandatory ISO 13485 standard and clarifies where the Medical Device Single Audit Program (MDSAP) is, and importantly, where it isn't, a valid substitute for market access. Key Questions: • What is the fundamental difference between ISO 13485 and an MDSAP audit? • Is ISO 13485 certification mandatory for all major Southeast Asian markets? • Which Southeast Asian country…
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