MFDS Inspection Types and Authority
MFDS has broad statutory authority to inspect medical device manufacturers, importers, distributors, and healthcare facilities.
Inspection types
| Inspection type | Description | Frequency |
|---|---|---|
| KGMP certification inspection | Initial certification of domestic manufacturers | On application |
| Periodic KGMP re-inspection | Certificate renewal (~every 3 years) | Scheduled |
| Overseas GMP inspection | Foreign manufacturing site certification | On application or for-cause |
| Market surveillance inspection | Product sampling, distributor/retailer inspection | Risk-based, often unannounced |
| For-cause inspection | Triggered by adverse events, complaints, or intelligence | As needed |
| Post-market surveillance audit | Review of PMS activities and records | Risk-based |
Legal authority
MFDS inspection authority derives from:
- Medical Devices Act, Article 36 (Inspection and investigation authority)
- Medical Devices Act, Article 37 (Authority to order suspension)
Refusing or obstructing a lawful MFDS inspection is a criminal offence under the Medical Devices Act.