Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
MHLW Mulls Sakigake System for SaMD with Medical Device as a Model: Official
The Ministry of Health, Labor and Welfare (MHLW) is contemplating the introduction of a sakigake fast-track designation system for software as a medical device (SaMD) by looking at one for medical devices, the ministry’s medical device review chief said on…
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