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

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

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Guidance on the Review and Approval of Artificial Intelligence (AI)-based Medical Devices
  • Registration Date 2023-07-20
  • Hit 3033

This guidance applies to machine Learning-enabled medical devices, in which machine learning-based AI technology is applied to diagnose, manage, or predict diseases by analyzing medical data. They also apply to AI software configured using hardware. For example, clinical decision supporting (CDS) and computer-aided detection/diagnosis (CAD) software fall under this category.

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  • Guidance on the Review and Approval of Artificial Intelligence (AI)-based Medical Devices.pdf Download

Division Digital Health Device Division

Written by Chungkeun Lee

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