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Business Suspension and Licence Cancellation

MFDS has authority to suspend or cancel manufacturer or importer licences (the immediately all The suspension remains in effect until MFDS confirms that corrective actions have been completed and re-inspection confirms compliance. is permanent and the entity to submit with demonstration of complete resolution of the issues that led to cancellation, including previously approved associated 품목허가) in serious cases.

Grounds for suspension​

  • Major GMP nonconformities not corrected within required timeframe
  • Manufacturing without a valid KGMP certificate
  • Repeated or systematic failure to comply with adverse event reporting
  • Supply of products materially different from what was approved

Grounds for cancellation​

  • Fraud or falsification in regulatory applications
  • Failure to comply with a mandatory recall order
  • Repeated serious violations
  • Criminal conviction related to medical device supply

Impact​

During suspension: the manufacturer/importer must immediately cease supply of all affected products. The suspension remains in effect until MFDS confirms that corrective actions have been completed and re-inspection confirms compliance. Cancellation is permanent and requires the entity to submit a new licence application with demonstration of complete resolution of the issues that led to cancellation, including re-approval of all previously approved products.

MFDS has authority to suspend or cancel manufacturer or importer licences in serious cases. A suspension is temporary and remains in effect until MFDS confirms that corrective actions have been completed and re-inspection confirms compliance. Cancellation is permanent and requires the entity to submit a new licence application with demonstration of complete resolution of the issues that led to cancellation, including re-approval of all associated 품목허가.