South Korea - Proposed Amendments to the Regulation on the Permission, Notification, Review, etc. of Medical Devices

T​he Ministry of Food and Drug Safety (MFDS) is amending the "Regulation on the Permission, Notification, Review, etc of Medical Devices" as follows:

1) Class 1 medical devices approved/certified/notified prior to changes in approval/certification/notification may be manufactured or imported for 6 months from the date of the change approval, etc.

2) Expansion of the scope of real-world evidence for medical devices as clinical investigation documents

3) Abolition of the notarization for translations of documents in foreign languages other than English