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 Digital Therapeutics(DTx)(Revision)
  • Registration Date 2020-11-04
  • Hit 7529

This guidance shall apply to the approval/certification of the manufacturing/import, review of technical documents, and approval of clinical trial protocols for a DTx that provide evidence-based therapeutic intervention to patients for preventing, managing, or treating medical disorders or diseases.


Note : This guideline was previously titled 'Guideline on Review and Approval of Digital Therapeutics (For Industry)'.

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Division Digital Health Devices Division

Written by Chungkeun Lee

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