Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
SaMD Could Be Eligible for 2-Stage Approval System: MHLW
The current two-step approval scheme allowed for certain medical devices can be also applied to software as medical device (SaMD), the Ministry of Health, Labor and Welfare (MHLW) said on May 30. The MHLW expressed this view during a session…
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