South Korea – South Korean MFDS reduces submission requirements for high-risk medical devices

The South Korean Ministry of Food and Drug Safety (MFDS) has moved to reduce registration submission requirements for Class IV high-risk medical devices.

According to a notification (link in Korean) from the regulator, manufacturers of Class IV devices will no longer be required to prepare and submit full Summary Technical Documentation (STED) files along with Korean technical files when applying for South Korean market authorization…