『One Audit, Six Markets? MDSAP vs. ISO 13485 in Southeast Asia』のカバーアート

One Audit, Six Markets? MDSAP vs. ISO 13485 in Southeast Asia

One Audit, Six Markets? MDSAP vs. ISO 13485 in Southeast Asia

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 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 officially accepts MDSAP audit reports? • What does it mean for a country to be an "Official Observer" of the MDSAP program? • When does Singapore's new rule regarding MDSAP acceptance come into effect? • For which markets is MDSAP not a direct substitute for ISO 13485? • How does the ASEAN Medical Device Directive (AMDD) influence these regulations? • Is pursuing an MDSAP audit a cost-effective strategy if you're only targeting Southeast Asia? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email info@pureglobal.com for tailored support.

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