South Korea: Major New Quality Standards, New Renewal Process for Medical Devices Go into Effect

A long-anticipated new law tightening government control over the quality of medical devices went into effect in South Korea in October. Also, a Medical Devices Renewal Program imposes requirements that all medical devices offered for sale in the country be reviewed periodically for safety and efficacy. Previously, not all devices were subject to such ongoing reviews. The new law published by the Ministry of Food and Drug Safety (MFDS) is designed to give consumers access to higher-quality devices whose safety is guaranteed, and to make medical devices produced in Korea more competitive in the global market by bringing quality standards more in line with international norms.

Also, devices already registered and authorized for sale in Korea will be required to apply for new product licenses under the more stringent requirements. However, details on renewals for already registered devices have not been determined yet.  Once granted, medical device licenses will be valid for five years. Until now, marketing authorizations for medical devices never expired.

The changes will impose a cost burden on manufacturers and are likely to push out some products that cannot meet the new standards.