Re-Evaluation System (재평가)
Re-evaluation (재평가) can be triggered at any time by MFDS based on new safety information and applies to any device already on the Korean market.
Triggers
- Significant international safety actions (FDA, TGA, CE withdrawal or major label update)
- New published evidence raising safety concerns
- Pattern of adverse event reports indicating a systematic safety issue
- MFDS market surveillance findings
Process
- MFDS notifies the 품목허가 holder
- Holder submits a re-evaluation dossier within the specified timeframe
- MFDS reviews the dossier
- MFDS decision: confirm / modify conditions / restrict use / revoke approval