Cracking the Code: South Korea's MFDS for FDA-Approved Devices

Medical Device Global Market Access · Aug 4, 2025 · 3m

This episode explores the process for medical device manufacturers to enter the South Korean market after receiving FDA approval. We delve into the specifics of the Ministry of Food and Drug Safety (MFDS) requirements, comparing its risk-based classification and submission pathways to the U.S. system. The discussion focuses on the practical steps for leveraging existing FDA testing data, the critical need for Korea Good Manufacturing Practice (KGMP) certification, and the role of a local Korea License Holder (KLH). Key Questions: • How does South Korea's four-class risk system for medical…