Re-Examination System (재심사)
Re-examination (재심사) is a Korean post-market requirement mandating periodic formal MFDS review of newly approved Grade III and IV devices after a defined period on the market to reassess benefit-risk balance based on accumulated post-market evidence.
Who is subject?
Grade III and IV devices that received a first-ever 품목허가 in Korea (새로운 허가).
Re-examination period
Typically 3 to 5 years from first approval. The manufacturer/importer must submit a re-examination application within a specified window before expiry (typically 6 months before).
What re-examination involves
- All post-market data accumulated during the period
- Analysis of adverse events, PMS data, international safety developments
- Updated clinical evaluation
- MFDS review of the re-examination dossier
Possible outcomes
- Confirm original authorisation
- Add new conditions (e.g., labelling warnings)
- Restrict the indication
- In rare cases, revoke the 품목허가
Re-examination vs re-evaluation
| Feature | Re-examination (재심사) | Re-evaluation (재평가) |
|---|---|---|
| Timing | Fixed — end of re-examination period | Variable — triggered by safety signal |
| Applicability | New approvals only | Any device on market |
| Initiation | Manufacturer applies proactively | MFDS initiates |
Related pages
"Failure to submit: If the re-examination dossier is not submitted by the deadline, MFDS may suspend or revoke the 품목허가 without further notice."