On December 12, 2022, the Ministry of Food and Drug Safety (MFDS) announced that they will resume KGMP on-site audits starting on January 1, 2023, for all Class 2, 3, and 4 devices for registration approvals in Korea. Over the COVID period, the MFDS was only doing paper, not on-site audits. However, as many global countries have relaxed COVID restrictions, these KGMP audits will resume in the US, Canada, Japan, Germany, and several other countries. On-site KGMP audits will not be resumed in China, Russia, and some other countries.
Please remember device approval in Korea has two main steps – a dossier submission and KGMP audit. Normally, a KGMP audit will include a representative from the Korean MFS or a notified body, plus a seasoned RA professional, as well as a trained interpreter/translator. While product registration licenses will now expire every 5 years in Korea, KGMP certificates need to be renewed every 3 years. If the device manufacturer has multiple manufacturing sites, normally the sites with the highest-risk devices and highest import volumes will be audited.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.
Source used in the article: https://www.mfds.go.kr/eng/index.do