Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Keidanren Calls for Clearer Classification Criteria for “Software as a Medical Device” to Promote Development
Japan’s biggest business lobby Keidanren stressed on October 19 the need to clarify the criteria for determining whether “software as a medical device (SaMD),” such as therapy apps and diagnostic imaging programs, will be classified as medical or non-medical devices.…
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