Korean KGMP Quality Management System Consulting

KGMP is the quality system standard for South Korea and, despite its name, is more closely modeled after ISO 13485:2003 and not US FDA requirements. All medical device importers or independent Third Party License Holders (contracted by foreign manufacturers in order to secure and maintain the Korea KFDA registration) must possess a quality system that conforms to Korean KGMP. 

In this way, the Korea Food and Drug Administration (KFDA) places much of the responsibility for quality system compliance on the importer, rather than the medical device manufacturer. Manufacturers that are establishing a direct sales office in South Korea must also comply with Korean Good Import Practice (KGIP). KGIP compliance is required for all importers and this responsibility typically falls upon the Third Party License Holder or distributor.

Korean KGMP Certificates

Since most companies do not set up a direct sales office in Korea, they rely on their distributor and/or Third Party License Holder to maintain compliance with KGMP and KGIP. A manufacturer selling in Korea must comply with KGMP requirements and this is very similar to ISO 13485. In fact, most manufacturers supply their ISO 13485 certificate to their Third Party License Holder in Korea and this serves as proof of compliance with KGMP requirements. The Third Party License Holder is then audited for KGMP and KGIP compliance and is issued a certificate by the KFDA. KGIP and KGMP certificates are valid for 3 years. 

Please contact us for more information or a free proposal on our KGMP consulting services.