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