2022 Volume 12 Issue 3 Pages 307-313
This document introduces the importance of Software as a Medical Device (SaMD) using digital technology, which is undergoing rapid technological innovation to solve social issues in our country, and METI’s support for it. METI has been initiatively attempted to encourage the research and development for SaMD, for example, the establishment of a centralized consultation service, consulting by experts, execute the research and development subsidies, formulating the guidelines, and inform the dissemination. We believe that the necessary of SaMD will increase in the future influenced by the necessity of operational efficiency and reformation of the work styles in the medical field. We will contribute to improve the environment of research and development to promote the innovative medical devices based on their social value, and we will also cooperate with other ministries and industries to establish the rules to ensure the safety of novel medical devices. Finally, we concluded by indicating that our expectations for SaMD are also reflected in the five priority areas of medical devices must be supported to effective research and development listed in the Second Basic Plan for Medical Devices, which was approved by the Cabinet in May of 2022.
