Korea tightens quality control for medical device tests

Moving to align its quality control requirements for medical devices with international standards, South Korea’s primary regulatory body, the Ministry of Food and Drug Safety (MFDS) will begin implementing Good Laboratory Practices (GLP) regulations on medical devices beginning May 1, 2019.

The regulations require conducting medical device safety tests in government authorized laboratories, and mandate close reporting and monitoring of the tests to ensure the quality and validity of the data produced.

The new requirements will increase the cost to manufacturers – of gaining medical device approval in Korea. They will also mean a longer time to get new products to market. Before, tests conducted by local laboratories were acceptable as long as they were approved by MFDS, now only tests conducted in laboratories strictly aligned with GLP will be in compliance.

In tightening its testing regulations, South Korea is seeking to ensure compliance with universal quality standards for the design, manufacture, export, and sales of various medical devices. Adopting the new standard would also smooth Korea’s participation in the International Medical Device Single Audit Program, facilitating speedier approvals of devices in the future.