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Export-Only Devices

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

  • Manufacturer must hold a manufacturer licence (μ œμ‘°μ—… ν—ˆκ°€)
  • KGMP certification still required
  • MFDS may issue an export certificate (수좜 의료기기 증λͺ…μ„œ) confirming KGMP compliance and that the product is not prohibited in Korea β€” required by many importing countries

To obtain an export certificate​

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