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.

In lieu of full STED files, MFDS will require the following STED-related documentation from Class IV device market applicants:

• Flow charts showing each step of the device’s manufacturing process;
• Detailed explanations of processes that could affect the performance and/or effectiveness of the device;
• Descriptions and indications of all sterilization methods, standards, validation cycles and conditions utilized in the device’s manufacturing process.

The MFDS announcement is expected to reduce submission preparation timeframes for Class IV device applicants, potentially easing South Korean market entry for higher-risk device manufacturers.

Additional South Korean regulatory resources from Emergo by UL:

• MFDS medical device registration and approval consulting
• Korea License Holder (KLH) in-country representation
• Process chart: South Korea MFDS regulatory approval pathway