In Korea, the holder 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 office 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.
What are the responsibilities of an ICC?
- An ICC in Korea is responsible for applying to the Ministry of Food and Drug Safety (MFDS) for product approval, making sure that Korean labeling is accurately added to the product, 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.
Pacific Bridge Medical can act as your ICC in Korea. Contact us for a free consultation to discuss your specific needs.
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