Japan to Review most Software-based Medical Devices by Same Criteria as Ordinary Medical devices

Telegraphing a desire to smooth the regulatory process for the growing ranks of software as a medical device (SaMD) product, a top Japanese regulatory agency official said the products will be evaluated as medical devices if they are designed to be used to analyze patient data.

In a September 9 online seminar, Yuzuru Okazaki, director of the Office of SaMD at the Pharmaceutical and Medical Devices Agency, said that some such devices, such as those worn by people to track their eating or their fitness, should not be subject to the same regulations as medical devices. But others, which produce, use and analyze clinical data, merit closer review by regulators.

Okazaki stressed that as the devices become more popular, they may present risks to consumers that deserve further investigation by regulators.