New Regulatory Units in Japan to be dedicated to Review of Software-Driven Medical Devices

With the ubiquity of smartphones driving a revolution in the use of software to perform medical functions, Japan’s authorities have responded by setting up several new regulatory units to review the growing class of software-driven devices.

The offices established in April include one at the Ministry of Health, Labor and Welfare (MHLW) to explore the safety and efficacy of software-driven medical device products, and another at the Pharmaceuticals and Medical Devices Agency (PMDA) to handle sales applications by device manufacturers. Manufacturers will be able to turn to that office with questions on permit applications and fees and the status of regulations.

While many modern medical devices employ software in one form or another, many are not considered software-driven. The SaMD products are defined as software that may work on general-purpose computing platforms but may also interface with other medical devices or other general-purpose hardware and software. The SaMD products range from software allowing a smartphone to view images obtained from a magnetic resonance imaging medical device for diagnostic purposes to Computer-Aided Detection software.