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MFDS — Structure and Role

The Ministry of Food and Drug Safety (MFDS, ė‹í’ˆė˜ė•Ŋ품ė•ˆė „ė˛˜) is Korea's central authority for medical device regulation, elevated to Ministry level in 2013.

Core responsibilities​

  • Market authorization (품ëĒŠí—ˆę°€) and notification (품ëĒŠė‹ ęŗ ) processing
  • KGMP certification for domestic manufacturers; recognition of foreign GMP certificates
  • Post-market surveillance, adverse event monitoring, recalls
  • UDI-K administration and KIMS database
  • Legislation (ęŗ ė‹œ) and guidance publication
  • Enforcement and inspections

Key contacts​