Refurbished Medical Devices in India: Access vs. Regulation

CDSCO’s Refusal vs. MoEFCC’s Approval: The Tug-Of-War Over Refurbished Medical Devices

In November 2025, the Ministry of Environment, Forest and Climate Change (MoEFCC) approved the import of multiple refurbished medical devices, including advanced CT and MRI scanners. Yet, less than a year earlier, the Central Drugs Standard Control Organisation (CDSCO) had categorically stated that such devices could not be imported due to the absence of a licensing pathway under the Medical Devices Rules, 2017. This regulatory dichotomy — one ministry greenlighting imports while another invokes procedural hurdles — epitomises India's fragmented approach to refurbished medical equipment, with implications that go far beyond the boundaries of bureaucratic coordination.

The core tension is unmistakable: Should India permit the import and use of refurbished high-end medical devices to expand affordable healthcare access, or should it prioritise stringent regulatory oversight to avoid compromises in patient safety and industrial self-reliance?

The Policy Instrument: Confusion and Contradictions

India currently has no dedicated regulatory framework to address refurbished medical devices. The existing roadmap is a patchwork. On one front, the Hazardous and Other Wastes (Management and Transboundary Movement) Rules, 2016 allow imports of certain used devices, subject to rigorous documentation, including maintenance history and quality assurance reports, and clearance from both the MoEFCC and Directorate General of Foreign Trade (DGFT). On the other front, the CDSCO operates under the Drugs and Cosmetics Act, 1940, and has extended the Medical Devices Rules to oversee all medical devices notified as "drugs." Under this regime, the absence of explicit provisions for refurbished devices leaves them in regulatory limbo, as evidenced by the Jan 2025 CDSCO directive which rendered such imports impermissible.

This dissonance is symptomatic of a larger challenge: How does India balance its dependency on imports for cutting-edge healthcare technology with the competing imperatives of ensuring patient safety and nurturing domestic manufacturing?

Why Stakeholders Defend Refurbished Imports

The argument for refurbished medical devices is firmly rooted in numbers. Consider the price differential: a new 1.5T MRI scanner costs ₹4–8 crore, while it can be refurbished and imported for ₹1–3.5 crore. A new PET-CT scanner is priced at an astronomical ₹20 crore, while a refurbished system costs just ₹60 lakh–₹3.5 crore. For hospitals in smaller cities and standalone diagnostics centers, this gap determines whether essential diagnostic services are even available. As per one 2023 industry estimate, refurbished imports have already enabled 60% of imaging systems in Tier-2 and Tier-3 towns, democratizing healthcare access in areas traditionally underserved.

Additionally, international manufacturers, represented by the Medical Technology Association of India (MTAI), advocate for allowing refurbished imports through Original Equipment Manufacturers (OEMs). They argue that OEMs can ensure these systems are restored to exacting standards; this aligns with global norms from developed markets such as the US and Germany, which allow for OEM-led refurbishment. For India, where 77% of advanced imaging technology is imported, such a model could ensure both affordability and accountability.

Practically, refurbished devices also align with the government's training and human resource strategies. With schemes like Pradhan Mantri Skill Development Program aiming to create a skilled workforce, making affordable equipment available for smaller setups would multiply on-the-job training opportunities for healthcare personnel, crucial for strengthening India's health infrastructure.

But What About Safety and Industry Impact?

On the flip side, the Association of Indian Medical Device Industry (AiMeD) warns of considerable risks. Their concerns are twofold: systemic and industrial. First, the absence of robust traceability systems for refurbished imports raises questions about past usage, remaining lifespan, and servicing standards. A poorly calibrated imported CT scanner could risk undue radiation exposure to patients, while failing to realize diagnostic precision. Second, such imports are seen as an existential threat to India’s nascent but growing domestic medical device manufacturing ecosystem, which has a market size of $11 billion and growing ambitions under the ‘Make in India’ programme. AiMeD points to past instances from the used electronics or vehicles sectors where India became a “global dumping ground” for developed countries' e-waste disguised as second-hand goods, and argues this precedent must not repeat with medical devices—a segment that directly impacts patient lives.

Refurbished imports also raise questions of regulatory bandwidth. As it stands, India’s medical device regulatory ecosystem is fragile and overburdened. The CDSCO’s scientific review capacity has struggled to even license indigenous devices appropriately. Extending this to scrutinize refurbishment compliance under international OEMs, particularly in the absence of operational SOPs, risks enormous gaps in enforcement. Patient well-being could inadvertently be traded off in the rush for affordability.

International Comparisons: A Look at Germany

Germany offers an instructive example. It permits the use of refurbished medical devices but enforces stringent conditions. Devices can only be refurbished by certified companies, often the OEMs themselves, which are held legally accountable for quality and safety parameters. The market is tightly regulated under the European Union's Medical Device Regulation (MDR), with provisions for traceability, compliance audits, and mandatory lifespan certification. As a result, Germany has built an ecosystem where refurbished systems reduce costs without compromising patient safety or domestic manufacturing stability. Could India emulate this model? Perhaps—not without first overhauling the fragmented mandates of its regulatory bodies.

Where India Stands

Despite the MoEFCC’s nod and the CDSCO’s objections, the path ahead appears murky. The February 2026 announcement of a government committee to craft a comprehensive refurbished devices policy is a step in the right direction, but risks abound. For starters, will it reconcile the competing jurisdiction of MoEFCC, CDSCO, and DGFT? Or will institutional inefficiencies persist? Additionally, the jury is out on whether the policy will calibrate affordability with safety and environmental goals without creating room for abuse.

Ultimately, India must decide whether it will merely tweak existing frameworks—which seem inadequate—or use this opportunity to develop a globally benchmarked regulatory pathway, one that enables affordable access without undermining patient safety or domestic innovation. Time is running out: the healthcare gap in Tier-2 and Tier-3 cities continues to widen, waiting for affordable answers.

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