Current Status and Future Prospects for SaMD

Abstract

The SaMD Forum was held on February 4, 2022, bringing together innovators and administrative officers, regulation staffs. The purpose of the forum was to promote the early commercialization of SaMD by establishing an examination system and structure that takes into account the characteristics of SaMD. At the forum, discussions were held among the parties concerned from three perspectives: research and development, regulatory review, and reimbursement pricing. There are four points that the author believes will be the subject of future work. The first is the issue of “endless software updates on post-marketing,” the second is the issue of “achievement criteria and the necessity of clinical trials,” the third is the issue of the concept of “prescribing of information,” and the fourth is the issue of “Innovation Assessment”. SaMD is evolving at an extremely rapid pace, and new issues will continue to emerge in the future. Therefore, it is important to continue discussions from the demand side among stakeholders through the continuous holding of the forum.