The development of artificial intelligence (AI)-based medical devices is expanding in scope and accelerating in pace. In order to improve patient access to these innovative medical devices, it is necessary to consider how the views of regulatory authorities have evolved from the early stages of development. This chapter outlines (1) regulatory trends in Japan and the USA regarding AI-based medical devices and (2) issues in performance evaluation. To deal with the constant improvements in performance that are inherent in AI, both Japan and the USA have established systems that allow the submission of improvement plans prior to the application for approval of devices, thereby simplifying subsequent applications. In addition, although there are differences in terms of transparency regarding the applicability of medical devices, the basic concept is the same in both countries. An important factor in the acquisition of data for performance evaluation is the protection of personal information. In Japan, a law has been enacted to allow the commercial use of personal information with opt-out consent. However, to evaluate the performance of a product, it is of major importance to ensure and prove that the data are sufficiently comprehensive to accommodate the diversity of analysis targets. As discussions on these issues continue into the future, medical device companies need to remain cognizant of the changes that occur and ensure that they stay abreast of the latest regulations.