Regulatory Strategy for Medical Devices in Korea

The medical device market in Korea is about $2.8 billion. To be successful in Korea, an excellent regulatory strategy is needed.

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 to get a medical device registered in Korea: a product license, Korean Good Manufacturing Practice (KGMP) certificate, and a device business license. Once these three licenses are obtained, it is legal to market a medical device in Korea.

New regulatory issues include local testing requirements, future inspections of foreign manufacturing sites to check for GMP compliance, and a new risk classification system. It is key to keep track of these upcoming changes to determine the appropriate regulatory strategy.

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