What Must Be Reported
Mandatory report categoriesβ
| Category | Deadline |
|---|---|
| Serious adverse event β death or serious deterioration of health (unexpected) | 15 calendar days |
| Serious adverse event β expected per risk management | 30 calendar days |
| Device malfunction β could cause death/serious injury if recurring | 30 calendar days |
"Serious deterioration of health" defined by MFDSβ
- 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?β
- Manufacturers (μ μ‘°μ μ) β Korean and foreign (via Korean agent)
- Importers (μμ μ μ)
- Healthcare facilities (μλ£κΈ°κ΄) β must report to both the manufacturer/importer AND MFDS directly