Software as a medical device (SaMD) may be eligible for conditional early review and approval in Japan including diagnostic imaging software and therapeutic apps.
Japan’s Pharmaceutical and Medical Devices Law, approved this year, permits manufacturers to get their products rapidly approved even if they were unable to enlist enough patients to conduct new clinical trials on the products. To be eligible for approval, manufacturers must submit both adequate data from previous trials and ensure measures are taken to mitigate risks once the products go to market.
Noriatsu Kono, director of Medical Device Evaluation of the Pharmaceutical Safety and Health Bureau, said they will make decisions on SaMD products on a case-by-case basis.