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    Ministry of Food and Drug Safety (Korea)

    South Korea's regulator for foods, drugs, cosmetics, and medical devices.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    MFDS regulates medical devices under the Medical Devices Act, classifying products into four risk classes. Higher-risk devices typically require KGMP certification and in-country clinical data when applicable.

    What this means in practice

    MFDS participates in MDSAP as an Affiliate Member and offers an innovative medical device fast-track designation for digital health and AI-based devices.

    Primary references

    3 sources
    Link health: 2 verified 1 needs review· last checked 2026-05-09
    MFDS·1FDA·1European Commission·1
    1. 1
      MFDS English
      Needs review
      MFDSmfds.go.kr
    2. 2
      FDA - Medical Devices
      Verified
      FDAfda.gov
    3. 3
      European Commission - Medical Devices
      Verified
      European Commissionhealth.ec.europa.eu

    Inline markers like [1] jump to the matching reference above.