Korea to mandate higher quality standards on medical devices

South Korea’s Ministry of Food and Drug Safety is instituting new quality standards on the testing, marketing and use of medical devices that are more in line with established international norms.

The new standards will go into effect in phases beginning July 1 and will include new requirements on whether a document review or an on-site inspection is called for, a longer list of materials required to be reviewed by authorities before a device can be approved for sale in Korea and an expansion in the scope of quality control at every step in the supply chain.

The new quality standards are designed to give consumers access to higher quality devices and to make medical devices produced in Korea more competitive in the global market. But they will impose a cost burden on manufacturers, especially domestic manufacturers. Many foreign firms already adhere to the new standards but will have to align themselves with Korea’s system.