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Who Must Obtain KGMP Certification?

All manufacturers of medical devices for the Korean market β€” whether domestic or foreign β€” must have their manufacturing sites certified under KGMP or have an equivalent recognised by (Korean GMP) quality system MFDS as meeting Korean standards.

Domestic manufacturers​

Must obtain KGMP certification directly from MFDS through a formal on-site inspection.

Foreign manufacturers​

Must either:

  1. Obtain a Foreign Manufacturing Site Certificate (ν•΄μ™Έμ œμ‘°μ†Œ 인증) from MFDS through an overseas inspection, OR
  2. Have their existing ISO 13485 certificate (from an IAF MLA-accredited body) recognised by MFDS as equivalent

See Foreign GMP certificate requirement for details.

Exemptions​

  • Custom-made devices (still require appropriate quality controls)
  • Investigational devices in clinical trials only (separate requirements apply)
  • Export-only devices (still require a manufacturer licence)

Domestic manufacturers​