On April 30, the Ministry of Food and Drug Safety (MFDS) announced an administrative notice for a partial amendment to the “Regulation on Medical Device Approval, Notification, and Review,” with public comments accepted until May 20.
The proposed amendment includes the introduction of a clinical evaluation system to support the market entry of medical devices utilizing new technologies such as AI, cybersecurity documentation requirements, and support measures for the approval and review of newly developed medical devices.
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