Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
MHLW Launches New Office to Fuel SaMD Commercialization
The Ministry of Health, Labor and Welfare (MHLW) on April 1 established a new office to propel the commercialization of software as a medical device (SaMD) in Japan, such as therapeutic apps and diagnostic imaging software. SaMD is defined by…
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