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

Related pages

• Who must obtain KGMP? · Domestic manufacturer certification · GMP for foreign manufacturers