Nov 20, 2019
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:
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.
New regulation will set specific registration requirements for IVD devices
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