Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Japan to Roll Out Pilot Program for SaMD Priority Review System
The Japanese health ministry is introducing a pilot-based priority review system for software as a medical device (SaMD), covering innovative and useful products expected to be developed and filed in Japan ahead of the rest of the world. Applications are…
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