Korea MFDS, Rapid Support for the Productization of Digital Therapeutic Devices

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The Ministry of Food and Drug Safety (MFDS) announced on December 7th that it has prepared the 'Guidelines for Safety and Performance Evaluation as well as Clinical Trial Protocol Development for Digital Therapeutic Devices' to support the rapid productization of domestically researched and developed digital therapeutic devices.


The main content of this guide includes methods and criteria for evaluating the performance and safety of digital therapeutic devices for the approval of improving hyperactivity and attention disorders (ADHD) as well as eating disorders. It covers aspects such as the evaluation methods for performance and safety during approval, clinical trial design methods, and criteria for effectiveness assessment.


In addition, the Ministry of Food and Drug Safety held the "Forum for Rapid Productization Support and Development Directions of Digital Therapeutic Devices" on December 7 to discuss the development direction of digital therapeutic devices.


※ Digital therapeutics refers to software medical devices used for the treatment, prevention, and management of medical conditions or disorders. This category includes applications, wearable devices, games, and other technologies utilized for treating conditions such as depression and anxiety disorders.





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