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Ministry of Food and Drug Safety 국민 안심이 기준입니다 YOUR SAFETY IS OUR STANDARD

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[Press release] MFDS strengthens bilateral cooperation with HSA to lead global digital health medical devices
  • Registration Date 2022-12-14
  • Hit 8983

□ 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.

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