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 Clinical Trials Design of Artificial Intelligence(AI)-based Medical Devices
  • Registration Date 2023-07-20
  • Hit 1675

This guidance applies to the regulatory pathways of clinical trial approval, manufacturing, and import licensing (subject to clinical trial data submission) or technical documentation review (subject to clinical trial data submission) for machine learning-enabled medical devices that analyze medical data to diagnose, control, or predict diseases.

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  • Guidance on Clinical Trials Design of Artificial Intelligence(AI)-based Medical Devices.pdf Download

Division Digital Health Device Division

Written by Chungkeun Lee

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