Japan Weighs Use of “Sakigake” Fast Track Review Process for Software-Based Medical Devices

A regulatory pathway that for the past six years has allowed Japan to accelerate the approval of innovative drugs and medical devices deemed to address urgent, unmet needs may be expanded to address the software as a medical device (SaMD) market.

In remarks at an online symposium in June, Noriatsu Kono, director of Medical Device Evaluation of the Pharmaceutical Safety and Environmental Health Bureau, said the “SAKIGAKE” fast track designation system employed since 2015, could be appropriate for some SaMD devices that meet needs-based criteria. That could dramatically shorten regulatory review times for the devices and allow for a smoother regulatory process.