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Import Bans and Market Withdrawal Orders

Import bans​

MFDS may issue an import ban for specific products or from specific foreign manufacturers when:

  • A device poses an unacceptable safety risk to Korean patients
  • The foreign manufacturer's GMP has been found seriously deficient
  • The product has been subject to a significant recall or withdrawal in another major jurisdiction without adequate corrective measures
  • The product fails to meet labelling or compliance requirements for the Korean market

Market withdrawal orders​

MFDS may order the withdrawal from the Korean market of all units of a specific product when:

  • A Class 1 recall is required but the manufacturer/importer has not acted
  • The device is found to be genuinely unsafe based on post-market data
  • The 품목허가 is cancelled by MFDS

Notification of import bans​

MFDS publishes import ban decisions on its official website and notifies industry through medical device bulletin notifications. Importers and distributors are legally required to check the MFDS notification list and maintain awareness of current bans before importing any device. Failure to comply with an active import ban may result in product seizure and regulatory penalties.

Appeal and review

Manufacturers and importers subject to an import ban may request reconsideration or appeal through the MFDS administrative review process. Requests should include evidence demonstrating that the grounds for the ban no longer apply or were incorrectly assessed.