KGMP is the Korean food and drug quality system certification.
A major step in registering medium- and high-risk medical devices in Korea is compliance with Korean Good Manufacturing Practice (KGMP) quality system regulations. Similar to the ISO 13485 quality system standard, the Korean Ministry of Food and Drug Safety (MFDS) requires the use of KGMP for all Class II, III and IV medical devices. MFDS will verify KGMP compliance through on-site inspections, conducted by its employees or with the assistance of third-party auditors.
With a strong track record in Seoul, we provide KGMP implementation and maintenance support to companies in Korea and abroad. We also help businesses prepare for on-site audits to verify KGMP compliance.