The Japanese government is considering a new program to shorten the approval review for software as a medical device (SaMD) and AI products. Currently, approval of these types of products can take several years in Japan. With the new regulations, approvals could be granted within one year. The Council for the Promotion of Regulatory Reform, an advisory body to Prime Minister Fumio Kishida, presented its policy recommendations in an interim report on December 22, 2022. The Ministry of Health, Labor, and Welfare (MHLW) will proceed with specific recommendations. The plan is to implement a new program by the end of fiscal 2023 and introduce new legislation in fiscal 2024.
Under the new system, the MHLW will promote a new system that allows real-world data collected at medical sites to be submitted instead of clinical trials for product approval. This new system will also raise reimbursement prices for SaMD and AI products after efficacy is confirmed.
Besides importing foreign SaMD products, Japan is developing its own products in this area too. Last year, Fujifilm’s AI software was approved in Japan for the diagnosis of esophagus and stomach cancers.
Japan lags behind developed countries in Europe and the US in the utilization of SaMD and AI. To date, while hundreds of these types of medical products have been registered in the West, only about 30 products have been approved in Japan. It is expected that this new policy will lead to further utilization of SaMD and AI in Japanese medical settings.