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Export-Only Devices

Export-only devices are exempt from ν’ˆλͺ©ν—ˆκ°€ / ν’ˆλͺ©μ‹ κ³ , but:

MFDS issues an export certificate (수좜 의료기기 증λͺ…μ„œ, 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 β€” 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