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Exporting from Korea β€” MFDS Export Certificate

Korean manufacturers exporting medical devices may need an MFDS export certificate (수좜 의료기기 증λͺ…μ„œ) as proof of regulatory status for importing countries.

Types of export certificates​

CertificatePurpose
Certificate of Free Sale (수좜 의료기기 증λͺ…μ„œ)Confirms device is freely sold in Korea and not banned
GMP Certificate for exportConfirms the manufacturer holds a valid KGMP certificate
Certificate of ComplianceConfirms 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 μ „μžλ―Όμ›):

  • The manufacturing site must be KGMP-certified
  • The product must have a valid ν’ˆλͺ©ν—ˆκ°€ or ν’ˆλͺ©μ‹ κ³  (or be an export-only device meeting requirements)
  • The product must not be banned in Korea

MFDS typically issues export certificates within a few business days.

Export-only devices​

See Export-only devices for specific rules on devices not sold in Korea.