South Korea MFDS Proposes Faster Class II Medical Device Certification

South Korea's Ministry of Food and Drug Safety (MFDS) has proposed a new one-stop certification and technical review process for Class II medical devices. This episode breaks down the amendment, announced on September 14, 2026, which aims to cut total review times from 40 days to 25. We cover who is affected, the crucial public comment deadline of October 26, 2026, and practical steps manufacturers should take now to prepare for this streamlined market access pathway. Key Questions: - What is the new 'one-stop' certification process proposed by South Korea's MFDS? - Which specific device class does this proposed change affect? - How much faster could the market access process become for Class II devices? - What is the deadline for submitting public comments on this proposal? - Why is simultaneous submission of certification and technical documents a major change? - What are the immediate actions regulatory teams should take in response to this news? - How can manufacturers prepare their technical documentation for this new process? - Why is consulting with a local representative in South Korea important right now? Sources: - https://www.gca-korea.com/post/korean-mfds-to-introduce-a-one-stop-certification-and-review-process-for-class-ii-medical-devices How Pure Global can help: Pure Global provides end-to-end regulatory consulting for MedTech and IVD companies seeking to enter or expand in over 30 global markets, including South Korea. Our team of local experts, supported by advanced AI technology, can help you navigate the MFDS regulatory landscape, act as your in-country representative, and prepare technical dossiers for efficient submission. We streamline the registration process, allowing you to access multiple markets with a single, coordinated strategy. For support with your South Korea market access plan, contact us at [email protected], visit https://pureglobal.com, or explore our free AI tools and device database at https://pureglobal.ai.