Companies without a physical location in South Korea must appoint a Korea License Holder to coordinate the registration of their medical device with the Ministry of Food and Drug Safety (MFDS, formerly the Korea Food and Drug Administration or KFDA). The License Holder also controls the device registration and can help to ensure compliance with Korea Good Manufacturing Practice (KGMP) requirements.
Responsibilities of the Korea License Holder
The Korean License Holder has substantial responsibilities in Korea, including:
- Submit product registration application
- Submit KGMP Certificate application
- Work with distributor(s) to obtain identical registration, in order to import registered products
- Coordinate Incident Reporting within Korea
- Act as the primary liaison with the MFDS
- Submit insurance reimbursement (HIRA) application
Benefits of independent representation in South Korea
Many companies elect to have a distributor submit their medical device registration in Korea and appoint their distributor as their primary Korea License Holder. Unfortunately, many non-Korean manufacturers do not realize that if the distributor is appointed as the primary Korea License Holder, the distributor owns the original medical device registration with the MFDS. This becomes a problem if the manufacturer wants to switch or add distributors at a later time.
Emergo offers independent Korea License Holder services, allowing you the freedom to select and switch or add distributors as needed.
Please contact us for more information on our Third Party License Holder representation services for Korea.