Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Regulatory Panel Members Want Clearer Standard for SaMD Efficacy in 2-Stage Approval Scheme
Members of the government’s regulatory reform promotion council on December 25 called for clarifying the standards for confirming the efficacy of software as a medical device (SaMD) under the two-stage approval system for these products. In November, the Ministry of…
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