The Pharmaceutical and Medical Devices Agency (PMDA) has added a video about regulating software as a medical device (SaMD) in Japan to its training materials.
In the five-minute, English-language video, PMDA provides global and Japanese definitions of medical devices, plus the International Medical Device Regulators Forum’s definition of SaMD. PMDA also covers the risk-based classification of medical devices and SaMD in Japan.
“Generally, SaMD has less risk than traditional MD because SaMD is noninvasive. Therefore, the risk classification of software as a medical device is different from that of medical devices other than SaMD,” PMDA said. “Software products equivalent to a Class I medical device have no risk and are not regulated by the [Pharmaceutical and Medical Device Act in Japan].”
PMDA goes on to describe how to review SaMD. In principle the process is the same as for non-software products. PMDA assesses the purpose of development and intended use before evaluating the safety and effectiveness of the product based on nonclinical and clinical data.
The agency is asking companies to specific input and output data, the algorithm and user environment in applications. Applicants should identify risks in SaMD and confirm requirements for software products’ lifecycle processes.
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