CMIC：2025年日本市场进入：软件作为医疗器械的现状报告（英文版）

Software as a medical device (SaMD) is a new wave of software-driven technology with the potential to deliver more personalized approaches to disease detection, management, and treatment. In Japan—which is already an important market for medical device and digital therapeutics—SaMD represents an exciting but challenging new era. As foreign companies look to conduct trials in Japan and enter the Japanese market, partnering with a local player like CMIC provides significant benefits. CMIC can h