Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Japan Deregulation Panel Proposes Two-Step Approval Scheme for SaMD
The Japanese government’s regulatory reform promotion council submitted its interim recommendation to Prime Minister Fumio Kishida on December 22, calling for the introduction of a two-stage approval scheme for software as a medical device (SaMD). The interim proposal urges the…
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