The Ministry of Health, Labor and Welfare (MHLW) on December 18 presented a proposal to define the scope of products…
REGULATORY
MHLW Aims to Set Up Evaluation Index, Sakigake System for SaMD by March
Japan is poised to compile an evaluation index for software as a medical device (SaMD) and introduce a pilot-based sakigake system for such products by the end of next March in a bid to facilitate commercialization in this fledgling field,…
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