[Press Release, July 2, 2020 / unofficial translation] Advancing into a Leader in AI Medical Devices - MFDS elected as the inaugural chair of an international organization's working group on AI medical devices - □ The Ministry of Food and Drug Safety (MFDS, Minister Lee Eui-kyung) has announced that the Steering Committee of the "International Medical Device Regulators Forum (IMDRF)" unanimously elected the MFDS as the inaugural chair of "Artificial Intelligence Medical Devices (AIMDs)" on June 25. * International Medical Device Regulators Forum (IMDRF): A council of regulators from 10 countries, including the United States and Europe, which leads global regulatory harmonization on medical devices. South Korea joined the IMDRF in December 2017. ** Artificial intelligence medical device: A medical device that uses a computer to implement part or all of human intellectual abilities through machine learning, etc. ○ The newly created working group plans to establish a range of international guidelines, such as the definition and applicable scope of artificial intelligence medical devices under the leadership of the MFDS. □ The MFDS has made various efforts to support the development of AI medical devices and create a proactive regulatory environment. ○ In 2017, the MFDS published a total of six guidelines, including the world's first “Guideline on the Review and Approval of Artificial Intelligence Medical Devices,” paving the way for approving 36 AI medical devices from 15 companies in Korea. ○ In addition, the "Medical Device Industry Promotion and Innovative Medical Device Support Act" was newly enforced in May to lay the groundwork for promoting the innovative medical devices industry including AI and supporting product development. □ Minister Eui-kyung Lee said, “this feat of being elected as chair indicates the international recognition of Korea's regulatory capability on AI devices and will also help the Korean medical devices industry strengthen export competitiveness." ○ “We will redouble our efforts to emphasize the role of Korea in global regulatory harmonization on medical devices by taking the lead in cooperation within international organizations such as the World Health Organization (WHO) and the International Electrotechnical Commission (IEC),” the Minister added.