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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​

TypeKorean
Marketing Authorization품목허가
Notification품목신고
Change authorization변경허가
Change notification변경신고
Product classification inquiry품목 분류 민원
GMP certificate applicationGMP 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)

Before uploading, ensure all documents:

  • Follow MFDS naming conventions (typically: [device name][document type][submission date])
  • Are uploaded in the correct folder structure within the eSubmission portal
  • Use standard file formats: PDF for technical documentation and reports, Excel (.xlsx) for test data summary tables, DICOM or equivalent for imaging data
  • Include electronic signatures (didsign or equivalent Korean digital signature) or certified scans of original wet signatures where legally required

Incomplete or incorrectly formatted submissions will trigger a 보충요청 and pause the review clock.

All documents must follow MFDS naming conventions and be uploaded in the correct folder structure within the eSubmission portal. File formats typically required: PDF for technical documentation, Excel for test data summary tables. Electronic signatures (or certified scans of original signatures) are acceptable for most documents.