India is preparing to launch a nationwide registry for implantable medical devices in a major step toward improving patient safety and strengthening oversight in the healthcare sector. The proposed system will maintain records of both medical implants and the patients receiving them, enabling better monitoring, traceability and accountability across the market.
According to a senior government official, the proposal is currently under review at the highest levels and is expected to be announced soon. The registry aims to prevent the excessive use of implants and ensure that only certified, high-quality devices are available in the Indian market. Data generated through the platform will also help guide policy decisions and procurement under government health schemes by distinguishing reliable products from cheaper, low-quality alternatives and limiting the entry of substandard imports.
India’s medical devices industry, currently valued at nearly $15 billion, is expected to grow to $50 billion by 2030. However, the country still depends heavily on imports, bringing in over one million high-risk implants every year, including cardiac stents, orthopedic implants, and pacemakers. The registry is being developed under the National Medical Devices Policy 2023, which seeks to address challenges such as inconsistent regulation, dependence on imports, rising costs, and gaps in monitoring as the sector expands.
The rollout of the registry will happen in phases, beginning with cardiac and orthopedic implants. Information will be collected from manufacturers, distributors, and hospitals before the system is gradually expanded to include all categories of medical devices. Industry experts say the registry will improve implant tracking, help identify patients during product recalls, enhance post-market safety monitoring, and build stronger accountability in the healthcare system.
The initiative also aligns with government programmes such as ‘Make in India’ and the Production-Linked Incentive (PLI) scheme, both aimed at increasing domestic manufacturing and reducing import dependence. While India exported medical devices worth around $3.8 billion in 2023-24, imports stood at nearly $8.2 billion, underlining the continued reliance on advanced foreign-made devices.
Through the National Medical Devices Policy 2023, the government aims to transform India into a global medical devices manufacturing hub, targeting a 10-12% share of the global market over the next 25 years and expanding the domestic industry to $50 billion by 2030. The upcoming registry is expected to play a crucial role in improving quality control, patient safety, and traceability across India’s MedTech ecosystem.
