Safety with affordability: New rules on medical devices should balance them

An interdepartmental high-level committee of the central government is reported to have begun discussion on framing rules to regulate the entry of refurbished medical devices into India. The pre-owned equipment market, valued at about ₹1,500 crore, accounts for nearly 10 per cent of India’s medical-device sector. These machines help hospitals in small cities keep costs down, but at present, the Medical Devices Rules, 2017, do not differentiate between new and refurbished devices. Nearly 75 per cent of medical devices in India are imported, and shortages of MRI (magnetic resonance imaging) machines, CT (computerised tomography) scanners, ventilators, and dialysis equipment remain widespread. The challenge is a real tradeoff. If import is allowed without adequate checks, unsafe or old machines could slip in, endangering patients. If import is blocked altogether, many hospitals will be forced to delay upgrades and diagnostic tests will become more expensive.

 

Refurbished medical devices are well regulated in many countries. The European Union’s Medical Device Regulation applies the same strict standards to refurbished devices as to new ones, requiring manufacturers or authorised partners to ensure traceability, safety testing, and post-market surveillance. In the United States, the Food and Drug Administration (FDA) draws a clear line between routine “servicing” and “remanufacturing”. If refurbishment alters the device’s performance or intended use, the refurbisher must meet full regulatory obligations like registration, quality system compliance, and safety reporting.

 

A balanced framework in India could combine these lessons with the country’s own needs. Imports should be restricted to original manufacturers or certified partners, while devices that are too old or have exceeded usage thresholds should be barred. Every refurbished machine could carry a unique ID, which would be accompanied by radiation and safety-test reports, and come with at least a one-year warranty. A public registry of refurbished devices and their compliance record would add transparency. At the same time, building certified refurbishment labs and testing facilities in India would not only help in regular safety checks but also generate skilled jobs and help create a credible domestic refurbishment ecosystem. Yet, one of the key hurdles in moving towards such a framework could be the shortage of trained technicians for calibration, radiation-safety checks, and quality audits. Investing in this workforce is as important as writing the rules, because patient safety depends on the rigour of testing and maintenance.

 

Setting up refurbishment units in India can lower costs for hospitals, create jobs, and build a reliable local base for safe devices. If refurbishment is added to the ongoing schemes such as the Promotion of Medical Devices Parks, it can help overcome this hurdle, build a strong domestic base for safe devices, and reduce dependence on imports. In the end, the refurbished-device debate is not about old machines versus new ones; it is about affordability, accessibility, and safety. A transparent, safety-first but affordability-conscious framework is the way forward. Done right, refurbished machines need not be stopgap measures; they can anchor a resilient health care system that expands diagnostics and treatment to underserved regions.