Regulating Medical Devices for Safety, Access and Scale

India’s medical devices sector is becoming central to India’s health-system and industrial policy agenda, shaping diagnosis, treatment, monitoring, surgical care, rehabilitation, emergency response and public health delivery. As the market expands and domestic manufacturing receives greater policy attention, the key challenge is to ensure that devices are safe, effective, affordable, serviceable and trusted across levels of care. Recent reforms have strengthened the regulatory architecture, but gaps remain in risk classification, standards, clinical evidence, testing capacity, pricing, procurement, maintenance, post-market surveillance and lifecycle accountability. These issues are becoming more urgent as India moves into more complex device categories, including imaging equipment, implants, diagnostics, critical care technologies, connected devices, software as a medical device and AI-enabled tools. A stronger ecosystem will require clearer standards, better institutional coordination, credible testing infrastructure and procurement systems that account for quality, lifecycle cost, uptime and real-world performance.

This invite-only roundtable will bring together a group of policymakers, regulators, manufacturers, clinicians, hospital leaders, procurement specialists, health economists, legal experts and public health voices to examine how India can regulate medical devices for safety, access and scale. The discussion will focus on the institutional conditions needed to support responsible innovation, reliable access and patient safety. It will also identify priority areas for deeper follow-up conversations, including refurbished medical devices, software-driven health technologies, AI-enabled diagnostics, procurement reform and India’s role in Global South medical technology cooperation.

Programme