Improvement of the Approval Review System to Promote the Practical Application of Software as a Medical Device

Abstract

Recently, various types of Software as a Medical Device (SaMD), including computer-aided diagnosis systems developed using artificial intelligence technology, digital therapeutics prescribed by doctors and installed to the patients’ mobile phone etc, have been developed and put into practical use. They are expected to be new options of therapeutic or diagnostic methods. Since it was clarified that medical software is classified as medical device by the amendment of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (Act No. 145 of 1960) in 2013, the number of the marketing approval of SaMD has been increasing. In addition, it is mentioned in the Basic Policy of Economic and Financial Management and Reform (decided by the Cabinet on June 18, 2021) and the Action Plan of the Growth Strategy (decided by the Cabinet on June 18, 2021) that the government of Japan will accelerate the approval process in order to promote the practical application of SaMD. Based on such background, Ministry of Health, Labour and Welfare of Japan published “DASH for SaMD” (DX (Digital Transformation) Action Strategies in Healthcare for SaMD) on November 24, 2020. This action plan is composed of the following four parts; 1) Early recognition of research seeds and publication of the review guide. 2) Centralization of the consultation contact desk. 3) Review system applicable to unique characteristics of SaMD. 4) Enhancement of structure for early realization. As for 2 and 4, these measures had been taken by April 2021, and as for 1 and 3, these measures are to be taken by the end of FY2021.