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eSubmission System User Guides

MFDS provides user guides for the eSubmission portal (의료기기 μ „μžλ―Όμ›) on its website.

Available user guides​

  • How to set up an account (Korean business registration required)
  • How to submit a ν’ˆλͺ©ν—ˆκ°€ application step by step
  • How to submit a ν’ˆλͺ©μ‹ κ³ 
  • How to apply for KGMP certification
  • How to register in KIMS / UDI portal
  • How to submit a change application (λ³€κ²½ν—ˆκ°€ / λ³€κ²½μ‹ κ³ )
  • 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.