Overview — Korean GMP (KGMP) and ISO 13485 Alignment
Korean Good Manufacturing Practice (KGMP, 의료기기 제조 및 품질관리 기준) is the Korean QMS standard for medical device manufacturers. It is largely aligned with ISO 13485:2016.
Why KGMP is critical in Korea
Unlike most other jurisdictions, KGMP certification is a prerequisite for 품목허가. There is no "self-declaration" pathway — MFDS must certify (or recognise) the GMP of every manufacturing site before a product can be approved.
KGMP vs ISO 13485
| Feature | KGMP | ISO 13485 |
|---|---|---|
| Legal basis | Medical Devices Act, Article 19 | International standard |
| Certification body | MFDS (domestic) or recognised by MFDS (foreign) | Accredited third-party CB |
| Inspection | MFDS on-site inspection required | Third-party audit |
| Scope | ISO 13485 aligned + Korean additions | Universal |
Core KGMP requirements
- Management responsibility and quality policy
- Resource management (personnel, infrastructure)
- Design and development controls
- Production and process controls
- Purchasing and supplier controls
- Inspection, testing, and monitoring
- CAPA (Corrective and Preventive Action)
- Complaint handling and adverse event interface