Reporting Timeframes
Timeframesโ
| Event type | Deadline |
|---|---|
| Death or serious deterioration โ unexpected | 15 calendar days from awareness |
| Death or serious deterioration โ expected per risk management | 30 calendar days |
| Malfunction with potential for death/serious injury if recurring | 30 calendar days |
When the clock startsโ
The clock starts from the date the manufacturer or importer becomes aware of the event โ including from a complaint, a healthcare facility report, or any other source.
Initial vs follow-up reportsโ
- Initial report: submit within the timeframe with available information, even if investigation is incomplete
- Follow-up report (์์ ๋ณด๊ณ ): submit with final investigation findings