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Export-Only Devices

Export-only devices are exempt from 품목허가 / 품목신고, but:

MFDS issues an export certificate (수출 의료기기 증명서, also called Certificate of Free Sale in some jurisdictions) confirming KGMP compliance at the manufacturing site and that the product is not banned or prohibited for marketing in Korea — required by many importing countries as proof of regulatory standing

To obtain an export certificate​

  • KGMP-certified manufacturing site required
  • Product must not be banned in Korea
  • Apply via MFDS eSubmission portal

Export certificate validity and renewal

Export certificates are typically valid for 1–3 years depending on the product category and MFDS issuance terms. To renew: • Apply via MFDS eSubmission portal 30–60 days before expiration • Confirm KGMP certification remains active • Declare the product remains compliant with Korean regulations (not banned or prohibited) • Provide updated manufacturing site information if applicable

Renewal processing typically takes 5–10 business days.