Central Drugs Standard Control Organisation is preparing to establish a national registry for implantable medical devices and patients, a major regulatory step aimed at improving patient safety, strengthening post market surveillance, and ensuring accountability across India’s healthcare ecosystem. The proposed system will collect real-time data from hospitals and healthcare providers to monitor device performance and identify adverse events more efficiently.

The registry is expected to cover high risk implantable devices including cardiac stents, pacemakers, orthopedic implants, neuro devices, and other long-term implantable technologies. Officials believe the centralized database will help regulators quickly detect defective devices, streamline product recalls, reduce overuse, and improve clinical outcomes for patients nationwide.

India’s medical device regulatory ecosystem has expanded significantly under the Medical Devices Rules, 2017, with all medical devices now regulated under the Drugs and Cosmetics Act. Implantable devices fall under higher-risk Class C and Class D categories, requiring stricter oversight and licensing compliance.

The initiative will also strengthen the country’s Materiovigilance Programme of India (MvPI), launched in 2015 to monitor adverse events linked to medical devices. According to official data, India currently has 174 Medical Device Adverse Event Monitoring Centres (MDMCs) supporting adverse-event reporting and safety surveillance nationwide.

Healthcare experts say the proposed registry could significantly improve traceability and transparency in India’s rapidly growing medical device market, which is projected to cross USD 50 billion by 2030 according to industry estimates. The registry is also expected to support evidence-based policymaking, improve patient follow up, and align India’s medical device governance with global best practices followed in the United States and Europe.

The move comes amid increasing global focus on post market device surveillance, particularly for implantable technologies where long term patient monitoring is critical for identifying device failures, safety risks, and performance issues. Industry stakeholders expect the registry to further strengthen regulatory compliance, encourage responsible manufacturing practices, and enhance public trust in advanced medical technologies across India’s healthcare sector.