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Advancing Software as a Medical Device Regulations in Asia-Pacific

Advancing Software as a Medical Device Regulations in Asia-Pacific

This position paper outlines best practices and actionable recommendations to guide the development of risk-based, fit-for-purpose regulatory frameworks for Software as a Medical Device (SaMD). It is intended for both regulators and industry to support convergence, improve predictability, and enable safe, timely access to innovation. Drawing on international guidance and regional insights, the paper highlights regulatory approaches from Australia, Japan, Singapore, and the U.S. as key reference points for the APAC region.

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