MFDS Overseas Inspection Program
MFDS conducts overseas inspections of foreign manufacturing sites for GMP certification and post-market surveillance purposes.
Inspection typesโ
| Type | Purpose |
|---|---|
| Pre-approval inspection | GMP certification for new ํ๋ชฉํ๊ฐ |
| Renewal inspection | Foreign GMP recognition renewal |
| For-cause inspection | Triggered by adverse events or safety concerns |
| Surveillance inspection | Routine monitoring of approved manufacturers |
Who pays?โ
The cost of MFDS overseas inspections (inspector travel, accommodation, fees) is borne by the Korean importer.
Preparing for an MFDS overseas inspectionโ
- All documentation must be available in Korean (translation required)
- Facility in normal operation during inspection
- Key personnel (QA Manager, production manager) present and available for interview
- All records complete and current
- Ensure KGMP alignment is demonstrated throughout the inspection