Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
MHLW Publishes Guidelines for Evaluating SaMDs Used for Behavioral Modification
The Ministry of Health, Labor and Welfare (MHLW) has announced guidelines for the evaluation of software as a medical device (SaMD) used for behavioral modification, calling for the implementation of clinical trials. The guidelines note that it is difficult to…
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