Episode Details

South Korea's Ministry of Food and Drug Safety (MFDS) has released Legislative Notice No. 2026-341, a proposal to amend the rules for medical device testing. This episode breaks down the most significant change: officially allowing medical device testing institutions to test digital medical devices, including Software as a Medical Device (SaMD) and AI-based technologies. We discuss what this means for manufacturers seeking market access in South Korea, the revised administrative penalty criteria for testing labs, and the crucial public comment deadline of September 14, 2026. Key Questions: - What is Legislative Notice No. 2026-341 from South Korea's MFDS? - How will this proposal change testing requirements for digital medical devices in South Korea? - Which types of devices, like SaMD and AI-based software, are impacted? - Why is the MFDS formalizing the role of medical device testing institutions for these products? - What are the revised administrative penalty criteria for testing institutions? - What is the deadline for submitting public comments on this proposal? - What practical steps should digital health manufacturers take now in response to this notice? - How can companies prepare their technical documentation for these new testing pathways? Sources: - https://www.foodmate.com/news/korea/413031.html How Pure Global can help: Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies, streamlining global market access. We act as your local representative in over 30 markets, develop efficient regulatory strategies, and use advanced AI to compile and manage technical dossiers for submission. Our team of local experts provides continuous regulatory monitoring to ensure your products remain compliant long after approval. Whether you are a startup or a multinational enterprise, Pure Global provides the strategic support and technology-driven solutions needed to access global markets faster. Contact us at info@pureglobal.com or visit https://pureglobal.com. Explore our free AI-powered regulatory tools and database at https://pureglobal.ai.