In South Korea, a medical product must be registered by a Korea-based entity. The registered holder is referred to as In-country Caretaker (ICC). Any foreign medical company that wishes to register, manufacture, and market its product in South Korea should have an ICC.
They can do so without having their own office or local agent as a distributor.
The responsibilities of an ICC are briefly listed below:
- In South Korea, an ICC is responsible for applying to the Ministry of Food and Drug Safety (MFDS) for product approval.
- An ICC is a liaison between the foreign manufacturer and the distributor in South Korea
- An ICC can coordinate the requests from distributors that require data from foreign manufacturers to be certified for the Korean Good Import Practice (GIP)
- An ICC is also responsible for looking after the labeling of the product in Korea
- An ICC ensures the accuracy of documentation and reporting of adverse events, product failures, etc.
Listed below are Freyr’s offerings for overseas manufacturers:
- Planning of drug development strategy and gap analysis
- Vendor selection and management (need-based)
- Trial fee payment to clinical sites
- Labeling and packaging of investigational product
Freyr can help your company establish its presence in South Korea and manage your product manufacturing in the country. We have in-depth expertise with the know-how to face the unique challenges you may have experienced with clinical trials in South Korea. Contact our team to learn more.