□ The Ministry of Food and Drug Safety (MFDS) of the Republic of Korea (Minister Oh Yu-Kyoung) held a bilateral meeting with

Health Sciences Authority (HSA) of Singapore on December 6 at COEX (located in Gangnam-gu, Seoul) in order to support

the advancement of domestic medical devices into the global market and strengthen bilateral cooperation in the field of

digital health medical devices.

ㅇ MFDS and HSA have agreed to exchange knowledge on approval policy for digital health medical devices including

artificial intelligence healthcare and build a close cooperation system by holding regular meetings in the future.

The next meeting is scheduled in March next year.

- The key points of this meeting were ▲ Introduction of fast track system on approval for digital health and

artificial intelligence(AI)-enabled medical devices ▲ Introduction of the “Guidance for Review and Approval of

AI-Enabled Medical Devices” published by the MFDS for the first time in the world ▲ Sharing information on

AI-enabled medical device-related guidelines published in Singapore ▲ Discussion on how to promote joint

clinical research to verify clinical effectiveness of AI-enabled medical devices.