Bridging the Gap: Risk-Based Regulatory Framework for Software as a Medical Device (SaMD) in India

K Lakshmi Sravani, K Krishna Sandhya, S Akshaya Sree

Abstract: Software as a Medical Device (SaMD) is a growing domain in digital health, encompassing AI-enabled wearable devices and mobile applications that perform medical functions independently. While India regulates medical devices under Medical Device Rules (MDR 2017), there is no specific guideline addressing SaMD, particularly AI/ML-driven software and adaptive algorithms. This study performs a gap analysis by comparing IMDRF, FDA, and EU MDR/MDCG guidelines with India's MDR, highlighting gaps in risk classification, lifecycle management, clinical evidence, and post-market surveillance. Based on the findings, a risk-based, lifecycle-oriented SaMD framework for India is proposed, enabling patient safety, regulatory clarity, and alignment with global best practices.

Keywords: Software as a Medical Device; SaMD; Regulatory Framework; India; AI/ML; Risk-Based Classification; Lifecycle Management

How to Cite?: K Lakshmi Sravani, K Krishna Sandhya, S Akshaya Sree, "Bridging the Gap: Risk-Based Regulatory Framework for Software as a Medical Device (SaMD) in India", Volume 14 Issue 12, December 2025, International Journal of Science and Research (IJSR), Pages: 2140-2141, https://www.ijsr.net/getabstract.php?paperid=SR251225133719, DOI: https://dx.doi.org/10.21275/SR251225133719