In-depth Analysis of September 2026 MFDS Medical Device Approval Status and the Clinical Trials Ecosystem
Korea’s medical device industry and biopharmaceutical ecosystem are facing a major paradigm shift starting in 2026. The Ministry of Food and Drug Safety (MFDS) has fully implemented the ‘Digital Medical Products Act (DMPA)’ and the completely revised ‘Regulations on Approval, Notification, and Review of Medical Devices (Notice 2026-6)’ to support the rapid commercialization of innovative … In-depth Analysis of September 2026 MFDS Medical Device Approval Status and the Clinical Trials Ecosystem