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eSubmission System User Guides

MFDS provides user guides for the eSubmission portal (의료기기 전자민원) on its website.

Available user guides​

  • How to set up an account (Korean business registration required)
  • How to submit a 품목허가 application step by step
  • How to submit a 품목신고
  • How to apply for KGMP certification
  • How to register in KIMS / UDI portal
  • How to submit a change application (변경허가 / 변경신고)
  • How to submit an adverse event report

Language​

User guides are currently in Korean only. For non-Korean speakers, work with a Korean regulatory consultant or your Korean importer/agent.

Technical support​

MFDS provides a technical helpdesk for the eSubmission portal. Contact details on the MFDS website.

Technical support​

Account Issues: If you cannot access your account, reset your password via the login page or contact the MFDS technical helpdesk. Only Korean business registration numbers (사업자등록번호) are currently accepted for account setup.