MFDS-Initiated Corrective Actions
MFDS has broad authority to initiate corrective actions when it determines a device poses an unacceptable risk to public health or fails to comply with regulatory requirements.
MFDS corrective action tools
| Tool | Description |
|---|---|
| Mandatory recall order | MFDS directs the manufacturer/importer to recall products |
| Sale suspension | MFDS orders suspension of sales/supply of a device |
| Import ban | MFDS prohibits importation of specific products or from specific foreign manufacturers |
| Licence suspension/cancellation | MFDS suspends or cancels a 품목허가 or business licence |
| Public advisory | MFDS publishes safety alerts on its website |
Grounds for MFDS-initiated action
- Post-market safety data indicates the device is unsafe
- GMP non-compliance discovered at inspection
- Fraudulent or false information in the application
- Failure to comply with mandatory adverse event reporting
- International safety action (FDA, CE withdrawal) triggers MFDS review
Related pages
Compliance and timelines
Manufacturers and importers must comply with MFDS corrective action orders within the timeframe specified in the order. For mandatory recalls, compliance is typically required within 10–30 days depending on the risk class and nature of the action. Non-compliance may result in criminal penalties, administrative fines, or suspension of business operations.