Software as a Medical Device (SaMD) represents a transformative opportunity for Japan’s healthcare system. By improving accuracy, efficiency, and decision-making, SaMD can alleviate labor pressures, enhance care quality, and optimize resources. However, realizing these benefits depends on a reimbursement system that reflects SaMD’s unique characteristics.

Japan has taken commendable steps through initiatives such as Dash for SaMD 2 (2023) and the FY2024 Health Insurance Medical Materials System Reform. These reforms mark progress, but additional measures are needed to ensure predictability, incentivize diffusion, and sustain innovation.

APACMed’s Market Access Committee’s position paper on ‘Advancing SaMD Innovation in Japan’, developed in collaboration with KPMG Japan, outlines our perspective on the critical role of Japan’s reimbursement system in fostering SaMD innovation, identifies gaps in current frameworks, and provides actionable recommendations to ensure innovation thrives.