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MFDS — Structure and Role

The Ministry of Food and Drug Safety (MFDS, 식품의약품안전처) is Korea's central authority for medical device regulation, elevated to Ministry level in 2013.

Core responsibilities​

  • Market authorization (품목허가) and notification (품목신고) 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 (고시) and guidance publication
  • Enforcement and inspections

Key contacts​

The Ministry of Food and Drug Safety (MFDS, 식품의약품안전처) is Korea's central authority for medical device regulation. MFDS was reorganized and elevated to Ministry level in 2013 from its previous status within the Korea Food and Drug Administration.