What Must Be Reported
Mandatory report categories
| Category | Deadline |
|---|---|
| Serious adverse event — death or serious deterioration of health (unexpected) | 15 calendar days |
| Serious adverse event — expected per risk management | 30 calendar days |
| Device malfunction — could cause death/serious injury if recurring | 30 calendar days |
"Serious deterioration of health" defined by MFDS
- Life-threatening illness or injury
- Permanent impairment of body function or structure
- Hospitalisation or prolonged hospitalisation
- Medical/surgical intervention to prevent permanent impairment
- Foetal distress, death, or congenital abnormality
Who must report?
- Manufacturers (제조업자) — Korean and foreign (via Korean agent)
- Importers (수입업자)
- Healthcare facilities (의료기관) — must report to both the manufacturer/importer AND MFDS directly