Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
MHLW Aims to Set Up Evaluation Index, Sakigake System for SaMD by March
Japan is poised to compile an evaluation index for software as a medical device (SaMD) and introduce a pilot-based sakigake system for such products by the end of next March in a bid to facilitate commercialization in this fledgling field,…
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