Korean KGMP Quality Management System Consulting

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KGMP is the quality system standard applied to the Korean domestic medical device manufacturer 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 KGIP (Korea Good Import Practice).

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. 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 overseas manufacturers have not set up a direct sales office in Korea, they rely on their distributor and/or Third Party License Holder to maintain compliance with KGIP. A manufacturer selling in Korea must comply with KGIP requirements and get KGIP approval; the overseas manufacturer must submit a valid ISO 13485 certificate (Class II, III, IV) or ISO 9001 certificate (Class I) to the KFDA. The Third Party License Holder is then audited for KGIP compliance and is issued a certificate by the KFDA. KGIP certificates are valid for 3 years.