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 ํ๋ชฉํ๊ฐ) in serious cases.
Grounds for suspensionโ
- 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 cancellationโ
- Fraud or falsification in regulatory applications
- Failure to comply with a mandatory recall order
- Repeated serious violations
- Criminal conviction related to medical device supply
Impactโ
During suspension: manufacturer/importer must cease supply of affected products. Cancellation requires a new licence application and re-approval of all products.