Medical Device Registration in Korea

The Korean medical device market is about $2.8 billion, compared to China's $7.5 billion market. Over 60% of Korea's medical device market comes from imported products.

Since 1997, medical devices have been regulated by the Korea Food and Drug Administration (KFDA). The KFDA is an independent agency under the supervision of the Ministry of Health and Welfare (MOHW). There are three processes required to get a device registered in Korea: a product license; Korean Good Manufacturing Practice (KGMP) certification; and a Device Business License.

In 2007, Korea fully implemented the Medical Devices Act, which enhanced medical device registration procedures. A certain amount of medical device technical review can now be performed by independent third party labs (similar to Notified Bodies).

The Medical Devices Act also increased Korean Good Manufacturing Practice (KGMP) requirements for foreign medical device manufacturers registering their products. Before, foreign manufacturers could usually meet Korean requirements by showing compliance with ISO 13485:2003 or US FDA QSR standards. Now, the KFDA often needs additional testing reports.

PBM can act as an In-Country Caretaker (ICC) and register the foreign company's medical device products in their own name.

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