The Ministry of Food and Drug Safety of Korea("MFDS") recently released its guidelines on safety and efficacy for DTx products aimed at treating depression and other mental issues such as panic disorder etc. (Dec. 14, 2022). Please see a brief summary on the standards for the MFDS' guideline as follows:
For panic disorder patients, medical institutions normally conduct medication treatment and although the efficacy for these drugs have been established, there are also side-effects such as dizziness, insomnia, eating issues etc. associated with such treatments. Furthermore, if patients rely on such drugs for an extended term, this can lead to withdrawal symptoms for patients. Therefore, in order to supplement the shortcomings of drug treatment, medical institutions have also instituted cognitive behavioral therapy (CBT) to supplement drug therapy for panic disorder patients.
Most DTx products used to treat panic disorders use mobile medical applications, which are deemed as SaMD digital medical devices in Korea. As all medical devices are regulated by the MFDS in Korea, the MFDS has released the following protocol as a guideline for assessing safety and efficacy of a DTx product:
If your company is currently developing DTx, please note that the above standards must be included a clinical trial that is conducted. In addition the UI must support Korean and thus this also lends support to conduct clinical trials locally here in Korea for DTx developers. Please feel free to reach out to us if you have any questions regarding DTx approval or any other medical device related inquiries at MDREX (pro@mdrex.co.kr).
※ Source: http://www.kmdianews.com/news/articleView.html?idxno=57214