In 2021, the APACMed Digital Health (DH) Committee published a position paper Digital Health Regulation in Asia-Pacific: Overview and Best Practices calling for the development and convergence of tailored, risk-based software regulatory frameworks across APAC countries. Highlighting the DH regulatory activities in leading markets in APAC like Australia, Japan, Singapore, Korea and China, identifying best practices and gaps and drawing comparisons to forward-thinking DH regulation from abroad such as in the United States.
Within this new paper, APACMed reviews India’s regulatory approaches for software regulation alongside international best practices, reiterating the framework for fit-for-purpose regulation of DH solutions.