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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The Wednesday TableShe had been on virtual calls since eight in the morning. The screen glowed. Her eyes burned. Plugged into Teams across time zones, she was digitally connected yet entirely isolated from the reality of Japan’s pharma market.She needed…





