Regulation for Medical Device Utilizing the Artificial Intelligence Technology in Japan

Abstract

It is said that the unique features of the medical device utilizing the Artificial Intelligence (AI) technology (AI medical device) are the character that specification and performance of the medical device would be changed at the post approval phrase, and also the character that performance of the medical device would be increased/decreased depending on quality of the teacher data. In these points, AI medical devices have different features from other medical devices and that would be a big challenge for the regulations of medical devices. The Ministry of Health, Labor and Welfare (MHLW) has been proceeding with preparing points to consider for the evaluation based on the report from the “Committee for promoting the utilization of AI in the field of health care”. The points to consider which was established by the MHLW on the most recent knowledge, however it is only for current AI medical devices so that it will be needed to revise the points to consider according to the development of technologies in near future. The regulatory sciences for innovative medical devices such as AI medical devices should be examined and considered in order to ensure the quality, safety and efficacy of such medical devices when used in the medical facilities with flexible manner. In this manuscript, I would like to outline the regulation of medical equipment utilizing AI technology, its current situation and current policy focusing on diagnostic imaging medical devices.