This article discusses how the CDSCO has issued its final Guidance Document on Medical Device Software (MDSW), clarifying how the Medical Devices Rules, 2017 apply to software used for medical purposes. The guidance distinguishes software as a medical device (SaMD) from software in a medical device (SiMD), and clarifies regulatory pathways, risk classification, clinical investigation, licensing, cybersecurity, quality management, and post-market surveillance requirements. It also exempts general wellness software from regulation while bringing predictive health software within regulatory scrutiny. New provisions include software lifecycle controls, Software Bill of Materials (SBOM), algorithm change protocols for AI systems, real-world evidence obligations, and alignment with the Ayushman Bharat Digital Mission (ABDM).
Please click here to read the full article by Sidharrth Shankar, Partner; Eshika Phadke, Senior Associate, published in Lexology.
Sidharrth (Sid) is a seasoned corporate lawyer and also the co-chair of the corporate practice with a core focus on private equity and mergers & acquisitions. Sid has substantial experience advising global private equity funds, multinational corporations and strategic investors on complex cross-border transactions across a broad spectrum of industries over the last two and a half decades, with over two decades in JSA itself.