In-Country Caretaker (ICC) for Medical Devices and Pharmaceuticals/Drugs in Korea

In Korea, the holder (agent) of a medical product registration must be a Korea-based entity. This entity is called the In-Country Caretaker (ICC). Foreign medical companies without their own local Korean operations and who do not want to use their distributor as their local agent can have an independent ICC in Korea maintain their product registrations in the name of the foreign manufacturer.

An ICC in Korea is responsible for applying to the Korea Food and Drug Administration (KFDA) for product approval; making sure that Korean labeling is accurately added to the products, documenting and reporting adverse events or product failures, etc.

An ICC can also act as a liaison between the foreign manufacturer and its Korean distributor. Distributors usually require data from foreign manufacturers so they can be certified for Korean Good Import Practice, and an ICC can coordinate these requests.

PBM can act as your ICC in Korea.

For more information on medical regulations in Korea, please see the following PBM publications and/or contact us to discuss your specific needs.