| Summary: | Machine learning (ML) and deep learning (DL) are changing the world and reshaping the medical field. Thus, we conducted a systematic review to determine the status of regulatory-approved ML/DL-based medical devices in Japan, a leading stakeholder in international regulatory harmonization. Information about the medical devices were obtained from the Japan Association for the Advancement of Medical Equipment search service. The usage of ML/DL methodology in the medical devices was confirmed using public announcements or by contacting the marketing authorization holders via e-mail when the public announcements were insufficient for confirmation. Among the 114,150 medical devices found, 11 were regulatory-approved ML/DL-based Software as a Medical Device, with 6 products (54.5%) related to radiology and 5 products (45.5%) related to gastroenterology. The domestic ML/DL-based Software as a Medical Device were mostly related to health check-ups, which are common in Japan. Our review can help understanding the global overview that can foster international competitiveness and further tailored advancements. Author summary Artificial Intelligence (AI), Machine learning (ML)/deep learning (DL) is in the early stages of its applications in the medical field. The current study, by investigating the state of regulatory-approved ML/DL-based medical devices in Japan, revealed that the clinical application of AI-based medical devices is closely related to society. It also emphasizes the need to understand the industrial demand, and sociocultural situation of each country, such as the state of health insurance, medical access, and health awareness, for global expansion of ML/DL-based medical devices. The study consists one of the two studies that revealed the approval status of AI-related medical devices among the leading members of international regulatory harmonization. Revealing the regulatory status of each country provides a global overview that can foster international competitiveness and further tailored advancements of ML/DL-based medical devices. Considering the current lack of relevant information about such devices, further studies revealing the status of regulatory-approved ML/DL-based medical devices are expected.
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