Refurbished medical devices: Why India is set to see a slugfest between global and domestic manufacturers

The import of refurbished or pre-used medical devices such as magnetic resonance imaging (MRI) scanners, computed tomography (CT) machines, robotic surgery systems, and other high-end diagnostic equipment has divided India’s medical device industry, with stakeholders sharply split over regulation. Indian manufacturers have raised concerns about safety, oversight and the impact on domestic industry. International medical device associations argue that instead of restrictions or bans, India needs a clear and robust policy under the Medical Devices Rules, overseen by the Ministry of Health and Family Welfare (MoHFW). On February 3, the Department of Pharmaceuticals under the Ministry of Chemicals and Fertilizers informed the Rajya Sabha that MoHFW has constituted a committee on “Policy on regulation of refurbished medical devices”, which will examine the scope of refurbished devices, develop methodologies to evaluate their safety, performance and remaining useful life, and suggest guidance for waste disposal. What are refurbished medical devices, what is the government’s policy on them, and what do industry players stand on this? We explain. ## What are refurbished medical devices? Refurbished medical equipment are essentially used devices and systems that have been restored to their original operating specifications and are then sold to hospitals and clinics at a lower cost. Most of these are capital-intensive technologies that cost several crores, depending on their configuration. These include high-end diagnostic and imaging systems such as CT scanners, MRI machines, PET-CT systems, advanced endoscopy and laparoscopy systems, and robotic navigation systems. A new 1.5T MRI machine (T stands for Tesla, the unit to measure magnetic field) can cost between Rs 4 crore and Rs 8 crore or more, while refurbished versions typically range between Rs 1-3.5 crore. A new PET-CT system can cost Rs 20 crore and above, compared with Rs 60 lakh to Rs 3.5 crore for refurbished systems. A new CT scanner may cost Rs 2-4 crore, while refurbished units generally range between Rs 20 lakh and Rs 2.5 crore. Such expenditure is often beyond hospitals in Tier-2 and Tier-3 cities, district centres, and standalone diagnostic facilities. Refurbished equipment can reduce upfront capital costs, enabling local access to advanced diagnostics and supporting affordability and decentralisation of healthcare. Although India’s medical device manufacturing ecosystem is expanding, the country continues to depend on imports for advanced imaging and highly specialised technologies due to technological complexity, advanced detector systems, precision component supply chains and established global manufacturing hubs. Although India’s trade data does not separately classify refurbished and new devices, refurbished high-end equipment is typically sourced from advanced healthcare markets where hospitals upgrade systems before the end of their functional life, including the US, Germany, Japan, and the Netherlands. ## What is the current Indian government policy on this? India has no dedicated regulatory pathway under the Medical Devices Rules, 2017 defining or governing refurbished devices. Medical devices were brought under a phased regulatory framework beginning in 2017 through the Medical Devices Rules, and in 2020 all medical devices were notified as “drugs” under the Drugs and Cosmetics Act, expanding central regulation but without creating a specific pathway for refurbished products. Currently, imports are allowed through no-objection certificates issued by an expert committee under the Ministry of Environment, Forest and Climate Change (MoEFCC). The committee can approve imports of 38 high-end and high-value medical equipment items, strictly based on a list prescribed by MoHFW’s Directorate General of Health Services. Industry estimates value the refurbished segment at around Rs 1,500 crore, accounting for nearly 10 per cent of India’s medical equipment market. Imports of used medical equipment are governed primarily under the Hazardous and Other Wastes (Management and Transboundary Movement) Rules, 2016. Earlier, used critical-care devices were prohibited. In December 2022, amendments permitted the import of certain “high-end and high-value used medical equipment” subject to stringent conditions. These include prior permission from MoEFCC after expert scrutiny, submission of maintenance history and quality assurance reports, compliance documentation, technical inputs from the Central Drugs Standard Control Organisation (CDSCO), and import authorisation from the Directorate General of Foreign Trade. In November 2025, a technical expert committee under MoEFCC cleared several high-end refurbished devices for reuse in India, including 16 CT scanners, 10 MRI systems, and 10 surgical robotic units. These approvals were issued under the regulatory framework governing refurbished or used high-value equipment, which falls under waste-management and reuse rules rather than conventional medical device import laws. The move contradicted CDSCO’s position, triggering a regulatory clash. In January 2025, CDSCO had stated that refurbished medical devices cannot be imported for sale or distribution because there is no licensing provision for them under the Medical Devices Rules, 2017. This created a legal inconsistency between environmental clearances issued by MoEFCC and CDSCO’s prohibition, raising concerns about policy coherence, patient safety, and domestic manufacturing. India also lacks a statutory definition distinguishing “used”, “refurbished”, “reconditioned”, or “remanufactured” medical devices, creating ambiguity over classification, licensing and compliance. The current debate – and what stakeholders are saying The debate centres on the absence of a clear regulatory pathway under the Medical Devices Rules. The issue is no longer whether refurbished devices should exist, but how they should be regulated. Another dimension concerns industrial policy versus healthcare access. Some stakeholders argue unrestricted imports could hurt domestic manufacturing. Others stress that refurbished equipment plays a vital role in expanding advanced diagnostics in Tier-2 and Tier-3 cities. Internationally, refurbished devices are regulated rather than universally banned. The Medical Technology Association of India (MTAI), representing more than 50 international manufacturers, argued that a blanket ban is neither practical nor desirable given affordability challenges. Welcoming the government’s decision to set up a policy committee, MTAI chairman Pavan Choudary said it aligns with the Union Budget’s commitment to train 1.5 lakh healthcare workers annually and India’s ambition to export 3 lakh healthcare professionals each year. He said that earlier interim measures imposed rigid age and remaining-life caps misaligned with global standards. As India pursues free trade agreements and bilateral trade agreements, Choudary urged a time-bound, globally aligned policy permitting refurbished devices only through original equipment manufacturers, ensuring legal accountability, service support, and patient safeguards. He added that an effective framework would expand affordable access, enable advanced training in smaller cities, strengthen Make in India, and support the Electronics Repair Services Outsourcing initiative. The Association of Indian Medical Device Industry (AiMeD), a forum representing domestic manufacturers, strongly opposes relaxing restrictions without a robust regulatory framework benchmarked to global standards such as the International Medical Device Regulators Forum. Rajiv Nath, forum coordinator, argued that refurbished devices pose risks from unknown histories, inconsistent performance, limited traceability, and shortened lifespans that cannot be fully addressed through post-facto checks. He said countries such as Indonesia, Thailand, Vietnam, China, Egypt, Brazil, Jordan, and Peru disallow such imports to protect public health. Nath argued India should prioritise new, indigenously manufactured devices under existing policies and initiatives rather than becoming a dumping ground for end-of-life equipment. He questioned claims of consumer benefit, asking whether clinics disclose equipment life, calibration dates, or the utility difference between decade-old and new machines. According to him, total medical device imports last year stood at Rs 76,000 crore, of which Rs 48,000 crore were medical electronics. He estimated Rs 12,000-15,000 crore worth of unauthorised trade in pre-owned equipment was ongoing without oversight and warned that legalising such imports could undermine Make in India and weaken preparedness in future health emergencies. Srinivasa Reddy, senior vice president at the medical technology company SS Innovations, said that in developed countries, medical equipment typically has a functional life of about 10 years, after which hospitals upgrade systems. Older units are refurbished, recalibrated, and sometimes updated with new software, but core components remain a decade old. When such systems enter India at similar price points as newly developed domestic products, they compete directly with Indian innovation, potentially discouraging investment in high-end technologies. He argued this risks turning India into a dumping ground for outdated equipment and weakening indigenous medical technology development.