Refurbished Medical Devices Policy: Why India is framing new rules (MoHFW committee)
India is working on a formal Refurbished Medical Devices Policy after the Ministry of Health and Family Welfare (MoHFW) constituted a committee to define what refurbished devices can be allowed, how their safety/performance should be evaluated, and how they must be disposed of at end-of-life.
This matters for UPSC because it sits at the intersection of public health access, regulatory governance, environmental safeguards, and Make in India concerns.
What is “refurbished” medical equipment?
Refurbished/used high-end medical devices typically refer to pre-owned equipment that is restored to working condition (often by OEMs or specialised entities) and sold for reuse—commonly including imaging and high-value diagnostic systems.
In India’s current debate, the focus is primarily on expensive, high-end devices such as MRI and CT scanners, because refurbished units can reduce upfront costs for hospitals and diagnostic centres.
What is the government’s latest step (Feb 2026)?
The government has constituted a committee on “Policy on regulation of refurbished medical devices” to bring control and clarity to this segment.
As per the PIB reply, the committee has three key tasks: define the scope (which devices can be refurbished), develop a methodology to evaluate safety/performance/remaining useful life, and suggest guidance for waste disposal of refurbished devices at end-of-life.
Why is there a policy conflict (health vs environment regulation)?
1) CDSCO position under Medical Devices Rules, 2017
CDSCO has clarified that refurbished medical devices cannot be imported for sale and distribution because there is no specific regulation/provision under the Medical Devices Rules, 2017 for such imports, and therefore licences are not issued for them.
This stance effectively tightens the health regulator’s gatekeeping role over what can enter India’s clinical ecosystem.
2) MoEFCC’s waste-management route
On the other hand, refurbished device imports have been dealt with largely through the lens of waste management under the Hazardous and Other Wastes (Management and Transboundary Movement) Rules, 2016, with environmental scrutiny and permissions enabling certain consignments historically.
This has produced a “regulatory standoff” where one wing treats these as reuse/controlled waste imports and another treats them as unregulated medical devices for sale.
Stakeholders: Who wants what, and why?
Pro-import argument (mainly global manufacturers / some user ecosystem)
A key pro-import claim is that refurbished systems can cut costs sharply (often cited as 60–70% cheaper), improving access to advanced diagnostics in Tier-2/Tier-3 cities and smaller hospitals.
Supporters also argue that a clear policy can enable India to build capability in repair/refurbishment services and high-skill technical jobs.
Anti-import argument (domestic manufacturers / Make in India concern)
Domestic manufacturers and some stakeholders warn that unrestricted refurbished imports could make India a dumping ground for end-of-life equipment, potentially undermining Make in India and creating patient-safety and maintenance risks if device history is unclear.
Their concern is not only clinical risk but also industrial policy: cheaper imports can distort demand away from domestic manufacturing and innovation.
Economic and healthcare impact: why this policy is high-stakes
1) Affordability and access
High-end imaging equipment is capital-intensive, and lower-cost refurbished options can help district-level facilities and standalone centres expand diagnostic capacity faster.
For public policy, this aligns with goals like reducing out-of-pocket expenditure and improving early detection of disease through wider diagnostics coverage.
2) Quality, uptime, and safety risks
Refurbished devices may have shorter remaining life, unknown usage conditions, and dependency on parts/service networks—so without robust standards, outcomes can vary widely.
That is why the committee’s mandate explicitly includes safety/performance testing and assessment of remaining useful life.
3) End-of-life waste and disposal
Large medical electronics ultimately become hazardous/e-waste, so the policy must integrate disposal responsibilities so India does not inherit unmanaged waste burdens.
The PIB reply specifically asks the committee to suggest guidance for waste disposal once the device finishes operational life in India.
What could a “good” policy look like? (UPSC analysis points)
A balanced national framework could include:
- Clear device eligibility: limited categories + age/residual life limits + certification norms.
- OEM-only refurbishment or strict accreditation: to ensure genuine spares, calibration, and service support.
- Mandatory testing and documentation: usage history, quality checks, performance benchmarks, and remaining life certificates.
- Strong post-market surveillance: reporting of adverse events, periodic safety checks, and recall mechanisms.
- End-of-life responsibility: disposal pathways and compliance so the system is environmentally sustainable.
Prelims pointers
- Refurbished medical devices are regulated under the Drugs and Cosmetics Act, 1940 and Medical Devices Rules, 2017.
- MoHFW constituted a committee to frame “Policy on regulation of refurbished medical devices” with focus on scope, safety/performance/remaining life methodology, and waste disposal guidance.
- CDSCO has clarified that refurbished devices cannot be imported for sale/distribution due to lack of a specific provision under MDR 2017.
Mains practice questions
- “Refurbished medical devices can improve affordability but raise risks of safety and environmental dumping.” Discuss and suggest a regulatory framework for India.
- Examine the regulatory overlap/conflict between health regulation (CDSCO) and waste-management rules (MoEFCC) in the context of refurbished medical device imports.
FAQs
Q1. What has the Government recently announced on refurbished medical devices?
MoHFW has constituted a committee to develop a policy to regulate refurbished medical devices—covering device scope, evaluation of safety/performance/remaining life, and waste disposal guidance.
Q2. Which regulator controls medical devices in India?
Medical devices are regulated under the Drugs and Cosmetics Act, 1940 and the Medical Devices Rules, 2017, administered through the health regulatory system (CDSCO framework).
Q3. Why is there a “regulatory standoff”?
Because imports have been dealt with under waste-management rules via environmental processes, while CDSCO has clarified that refurbished devices cannot be imported for sale/distribution due to lack of specific regulation under MDR 2017.
Q4. What are the key benefits of allowing refurbished devices (if regulated well)?
They can reduce costs for high-end diagnostics and help smaller cities and hospitals access equipment like MRI/CT scanners more affordably.
Q5. What are the key risks?
Potential risks include patient safety issues (unknown history/shorter life), maintenance challenges, and India becoming a destination for end-of-life global equipment without strong disposal rules.
Q6. What is the committee expected to deliver?
A unified approach that sets eligibility and testing standards, ensures safe clinical use, and integrates end-of-life waste disposal so regulation is consistent and enforceable.
