The debate over importing refurbished or pre-used medical devices — such as MRI scanners, CT machines and robotic surgery systems — has exposed a policy fault line between healthcare access and industrial strategy in India. While hospitals argue that refurbished equipment expands affordable access to advanced diagnostics, domestic manufacturers warn of safety risks and adverse impacts on indigenous industry.
On February 3, the Department of Pharmaceuticals informed the Rajya Sabha that the Ministry of Health and Family Welfare (MoHFW) has constituted a committee to examine a “Policy on regulation of refurbished medical devices.” The move comes amid regulatory inconsistency and growing industry pressure for clarity.
What Are Refurbished Medical Devices?
Refurbished medical devices are previously used systems restored to their original operating specifications and resold at lower cost. These are typically high-value capital-intensive technologies, including:
- MRI (Magnetic Resonance Imaging) scanners
- CT (Computed Tomography) machines
- PET-CT systems
- Robotic surgical platforms
- Advanced endoscopy and laparoscopy systems
The price differential is substantial. A new 1.5T MRI machine may cost ₹4–8 crore or more, whereas refurbished versions range from ₹1–3.5 crore. Similarly, a new PET-CT system may cost ₹20 crore and above, compared to ₹60 lakh–₹3.5 crore for refurbished units.
For Tier-2 and Tier-3 cities, district hospitals, and standalone diagnostic centres, refurbished systems significantly reduce upfront capital costs and enable decentralised healthcare delivery.
India’s Current Regulatory Framework
India does not have a dedicated regulatory pathway for refurbished devices under the Medical Devices Rules, 2017. Medical devices were brought under phased regulation beginning in 2017, and in 2020 all devices were notified as “drugs” under the Drugs and Cosmetics Act. However, no specific provision distinguishes refurbished products.
At present:
- Imports are governed mainly under the .
- No-objection certificates are issued by an expert committee under the (MoEFCC).
- Technical inputs are provided by the (CDSCO).
- Import authorisation is required from the Directorate General of Foreign Trade.
In November 2025, a technical committee under MoEFCC cleared several refurbished CT, MRI and surgical robotic systems for reuse. However, CDSCO had earlier stated that refurbished devices cannot be imported for sale or distribution due to the absence of licensing provisions under the Medical Devices Rules. This created a regulatory clash between environmental clearance and medical device regulation.
Industrial Policy vs Healthcare Access
The refurbished device market is estimated at around ₹1,500 crore — nearly 10% of India’s medical equipment market. Total medical device imports last year were about ₹76,000 crore, with medical electronics accounting for ₹48,000 crore.
Two contrasting positions have emerged:
International manufacturers and hospital stakeholders argue:
- A blanket ban would restrict affordable access to advanced diagnostics.
- Refurbished devices are regulated — not banned — in many developed markets.
- A time-bound, globally aligned framework allowing imports via original equipment manufacturers (OEMs) could ensure accountability and service support.
- Affordable access aligns with healthcare workforce expansion and medical training goals.
Domestic manufacturers contend:
- Refurbished devices may carry unknown usage histories and shortened lifespans.
- Post-facto compliance checks cannot fully guarantee safety and traceability.
- Permitting imports risks turning India into a dumping ground for end-of-life equipment.
- It may undermine Make in India initiatives and discourage domestic innovation in high-end technologies.
The debate thus goes beyond safety to questions of industrial competitiveness and technological self-reliance.
Safety, Sovereignty and Regulatory Gaps
A key concern is the absence of statutory definitions distinguishing “used,” “refurbished,” “reconditioned,” or “remanufactured” devices. Without clear classification:
- Licensing pathways remain ambiguous.
- Accountability mechanisms are weak.
- Patient safety standards may vary.
- Disposal and e-waste management risks increase.
Countries such as Indonesia, Thailand, Vietnam, China, Egypt, Brazil, Jordan, and Peru reportedly restrict such imports to protect domestic industry and public health.
India’s challenge is to reconcile affordability with safety and industrial development — without regulatory fragmentation.
The Way Forward: Toward Coherent Policy
The newly constituted MoHFW committee is expected to:
- Define refurbished medical devices in statutory terms.
- Develop methodologies to assess safety, performance, and remaining useful life.
- Establish traceability and maintenance documentation standards.
- Clarify waste disposal and end-of-life management norms.
A balanced framework could include permitting imports only through original manufacturers, mandating disclosure of service history, enforcing calibration standards, and aligning with international benchmarks such as the International Medical Device Regulators Forum.
The policy decision will determine whether India prioritises rapid healthcare expansion through cost reduction or emphasises domestic manufacturing and technological sovereignty — or attempts to achieve both through calibrated regulation.
What to Note for Prelims?
- Medical devices are regulated under the .
- Imports of used devices are currently governed under the .
- CDSCO functions under the .
- MoEFCC issues environmental clearances for certain refurbished imports.
What to Note for Mains?
- Examine the tension between industrial policy and healthcare affordability in regulating refurbished medical devices.
- Discuss regulatory coherence and inter-ministerial coordination challenges.
- Evaluate the implications for Make in India and health sector decentralisation.
- Link to GS Paper II (Governance, health policy) and GS Paper III (Industry, trade policy, healthcare infrastructure).