eSubmission System (의료기기 전자민원)
All 품목허가, 품목신고, GMP, and classification inquiries are submitted electronically via the MFDS eSubmission portal.
Portal details
- URL: emed.mfds.go.kr
- Access: Korean business registration number required; foreign applicants work through their Korean importer/agent
Submission types
| Type | Korean |
|---|---|
| Marketing Authorization | 품목허가 |
| Notification | 품목신고 |
| Change authorization | 변경허가 |
| Change notification | 변경신고 |
| Product classification inquiry | 품목 분류 민원 |
| GMP certificate application | GMP 인증 신청 |
Before submitting
- All documentation must be in Korean (or translated)
- KGMP / foreign GMP certificate must be active and in scope
- Application fees paid (per MFDS fee schedule)