Outline of new MHLW guidelines on the treatment of disease risk indicating software as a medical device

Development and commercialization of innovative products/services — including smart technologies — have recently been accelerating rapidly in the healthcare industry. One example is the growing use of AI/machine learning technologies in medical devices that perform diagnosis and/or testing. Further, many software applications and wearable devices are being launched that enable ordinary consumers to collect health-related data, etc.

Commercializing innovative healthcare products/services must of course comply with healthcare regulations, including the Pharmaceuticals and Medical Devices Act of Japan. Whether a product constitutes a “medical device” will materially impact a company’s regulatory response, commercialization strategy and the time and resources required for commercialization. Although this analysis is essential, companies often have difficulty determining whether innovative products will be treated as medical devices due to a lack of relevant precedents. Accordingly, the Ministry of Health, Labour and Welfare (MHLW) issued the “Guidelines for determining whether a program is a medical device” to help companies assess whether software will be treated as a medical device. The Guidelines were last updated on March 31, 2023 to provide further clarification and guidance.