What Are The Key Differences Between Registering Medical Devices In Korea And Other Markets?

Registering medical devices in Korea involves navigating the Ministry of Food and Drug Safety (MFDS) regulations, which emphasize local clinical data and Korean Good Manufacturing Practice (KGMP) certification. Unlike other markets, Korea requires a local representative for foreign manufacturers and often demands additional documentation, making the process more complex and time-consuming.

Leave a Reply

You must be logged in to post a comment.