MFDS Signs MOU with Korean Society of Digital Therapeutics for Review and Clinical Consultation

[Asia Economy Reporter Kim Young-won] The Ministry of Food and Drug Safety (MFDS) is partnering with the Korean Society of Digital Therapeutics to support the rapid commercialization of digital therapeutics (digital therapeutic devices) and the proactive establishment of safety management standards.

On the 30th, the MFDS's National Institute of Food and Drug Safety Evaluation announced that it will hold a business agreement ceremony in the afternoon and sign an agreement with the Korean Society of Digital Therapeutics.

Digital therapeutic devices refer to software medical devices that use digital technology proven to have therapeutic effects to prevent, manage, or treat patients' diseases or disabilities. The Korean Society of Digital Therapeutics was founded in October last year to establish research and development and academic exchange in digital therapeutics.

The main contents of this agreement include consultation on the review, clinical trials, and research of digital therapeutic devices, as well as joint hosting of education, seminars, and symposiums related to digital therapeutic devices.

The MFDS explained that it plans to work together with the Korean Society of Digital Therapeutics to enhance regulatory expertise on digital therapeutic devices by sharing the latest domestic and international regulatory information and expanding consultations on clinical efficacy.

Following the business agreement ceremony, the two organizations will hold a meeting to share the development results of clinical evaluation guidelines for digital therapeutic devices and discuss the current status of work and future development directions. Currently, there are 13 domestic digital therapeutic devices that have received Investigational New Drug (IND) approval from the MFDS, including those for insomnia, anxiety disorder improvement, and respiratory rehabilitation, but no products have been approved yet.

An MFDS official stated, "Through this agreement, the expertise in approval and review of digital therapeutic devices will be enhanced, and the cultivation of professionals with abundant field experience will help strengthen regulatory science capabilities for digital therapeutic devices."

This content was produced with the assistance of AI translation services.