Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
MHLW Drafts Guidelines for Evaluating SaMD Used for Behavioral Modification
The Ministry of Health, Labor and Welfare (MHLW) has drafted guidelines for evaluating software as a medical device (SaMD) used for behavioral modification. The guidelines stress the need for clinical trials since no approval criteria currently exist for such products…
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