Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
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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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