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 quality documentation, batch records, and procedural records must be available in Korean or with certified Korean translation. MFDS may accept documents in English for reference, but all records of regulatory significance must be in Korean.
- 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