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.