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South Korea MFDS Proposal for Digital Medical Device Testing: What Manufacturers Need to Know
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: -…
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