MFDS-Initiated Corrective Actions
MFDS has broad authority to initiate corrective actions when it determines a device poses a risk to public health.
MFDS corrective action toolsโ
| 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 ํ๋ชฉํ๊ฐ or business licence |
| Public advisory | MFDS publishes safety alerts on its website |
Grounds for MFDS-initiated actionโ
- 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