DOMESTIC RA
DOMESTIC RA
3rd Party Holder

icmcert@naver.com

+82-2-851-3111
Overseas medical device manufacturers without local branches must designate an agent in Korea to register medical devices with the Ministry of Food and Drug Safety (MFDS). As an agent with an import business permission, we can help you with the management of medical device registration and compliance with Korean Good Manufacturing Practice (KGMP) requirements.
Most overseas manufacturers designate distributors as medical device registration and importers. In most cases, overseas manufacturers do not value the fact that distributors manage medical device registration. In this case, foreign manufacturers may have problems when changing distributors in the future. As an independent third-party holder, we allow manufacturers to manage distributors.