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GMP Standards Notification

The MFDS GMP Standards Notification (의료기기 제조 및 품질관리 기준) defines the detailed requirements of the Korean Good Manufacturing Practice (KGMP) system, largely aligned with ISO 13485:2016.

Key chapters​

  • Management responsibility
  • Resource management
  • Product realisation (design, development, production)
  • Measurement, analysis, and improvement (CAPA, internal audit)
  • Korean-specific documentation requirements and GMP certificate application

IVD-specific GMP​

A separate chapter (or separate notification under the IVD Act) covers IVD-specific GMP requirements.

2016': "(Note: As of 2024, MFDS has not yet issued formal guidance on full adoption of ISO 13485:2022. Compliance with ISO 13485:2016 and existing KGMP requirements remains the current standard. Confirm with MFDS whether early adoption of 2022 version is acceptable.)"