South Korea MFDS Proposes Faster Class II Medical Device Certification

Podcast: Medical Device Global Market Access · Pure Global

Opublikowano: 2026-10-15

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...