South Korea is pushing to standardize international regulations on medical devices fueled by artificial intelligence technologies and to eliminate structural barriers to marketing those and other innovative medical device technologies.
In July, Eui-Kyung Lee, who heads Korea’s Ministry of Food and Drug Safety, pushed medical device regulators from nine other countries to establish common guidelines for defining artificial intelligence devices. As the first chair of Artificial Intelligence Medical Devices of the International Medical Device Regulators Forum, she is instituting the new guidelines a priority. At home, Korean regulators have enacted a series of laws since May, geared to support the development of the medical device, medical technology and in vitro diagnostics industries. They have approved a string of new medical device technologies, from mammography software to an AI-powered lung scan. And since March, MFDS has approved the use in emergency situations of three COVID-19 test kits.