In Japan, New Guidelines Released on When Software is Considered a Medical Device

New guidelines on software applications released by Japanese regulators seek to help manufacturers and consumers understand which programs, features, and products constitute a medical device, and how such products—increasingly prevalent in the Japanese market—will be regulated.

Released in March by the Ministry of Health, Labor and Welfare (MHLW), the guidelines classify software as a medical device if, among other features, it uses entered data to display the risks of diseases, it is used to diagnose, treat, or prevent disease, or it is used to support another medical device by, for example, processing or analyzing data obtained from the device.

Examples of software products not classified as medical devices are wellness applications that monitor daily exercise, track diet, help users manage weight, etc.

The release of the guidelines is part of a flurry of activity by Japanese regulators to respond to a revolution in the use of smartphone software to perform medical and wellness functions. In April, Japan’s authorities set up several new regulatory units to review the growing class of software-driven devices and to handle sales applications by device manufacturers.