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Foreign GMP Certificate Requirement

Foreign manufacturers wishing to supply devices to Korea do not require a Korean manufacturer license, but must demonstrate GMP compliance through one of two routes before 품목허가 (device approval) can be granted:

Route 1 — MFDS overseas inspection (해외제조소 현지실사)​

  1. Korean importer submits overseas inspection application to MFDS
  2. MFDS schedules inspection (with manufacturer cooperation)
  3. MFDS inspectors visit the foreign site
  4. If satisfactory: Foreign GMP Recognition Certificate (해외제조소 인증) issued

Route 2 — ISO 13485 certificate recognition (most common)​

MFDS recognises ISO 13485 certificates from IAF certification bodies holding Multilateral Recognition Agreement (MLA) accreditation. Requirements:

  • Certificate must be current
  • Certificate scope must cover the specific products being applied for
  • Certification body must be IAF MLA member-accredited

Route comparison​

FactorMFDS overseas inspectionISO 13485 recognition
CostHigher (inspector travel)Lower
Timeline6–12 monthsFaster (if certificate scope matches)
CertaintyHighDepends on certificate scope matching

Route 2 — ISO 13485 certificate recognition​

Scope specificity: The ISO 13485 certificate scope must explicitly list the device category, manufacturing process type, and sterilization method (if applicable) matching the 품목허가 application. Overly broad scopes (e.g., 'all active medical devices') may require scope clarification from the certification body or MFDS review.