Business Suspension and Licence Cancellation
MFDS has authority to suspend or cancel manufacturer or importer licences (and 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.