Exporting from Korea — MFDS Export Certificate
Korean manufacturers exporting medical devices may need an MFDS export certificate (수출 의료기기 증명서) as proof of regulatory status for importing countries.
Types of export certificates
| Certificate | Purpose |
|---|---|
| Certificate of Free Sale (수출 의료기기 증명서) | Confirms device is freely sold in Korea and not banned |
| GMP Certificate for export | Confirms the manufacturer holds a valid KGMP certificate |
| Certificate of Compliance | Confirms device meets Korean regulatory requirements |
Who needs an export certificate?
Most importing countries (EU, US, ASEAN, etc.) require an export certificate or Certificate of Free Sale as part of their import registration / market approval process for foreign devices.
How to obtain
Apply via the MFDS eSubmission portal (의료기기 전자민원):
- The manufacturing site must be KGMP-certified
- The product must have a valid 품목허가 or 품목신고 (or be an export-only device meeting requirements)
- The product must not be banned in Korea
MFDS typically issues export certificates within 3–5 business days. Expedited processing may be available upon request; contact the MFDS eSubmission helpdesk for details.
Export-only devices
See Export-only devices for specific rules on devices not sold in Korea.