Regulating Refurbished Medical Devices in India: Balancing Healthcare Access and Industrial Policy

Why in News ?

The Department of Pharmaceuticals recently informed the Rajya Sabha that the Ministry of Health and Family Welfare (MoHFW) has constituted a committee to draft a policy framework for regulating refurbished medical devices in India.

The proposed policy will:

• Define the scope of refurbished devices,
• Establish safety and performance assessment mechanisms,
• Determine standards for remaining useful life,
• Recommend disposal and waste management protocols.

The debate now centres not on whether refurbished devices should be allowed, but on how to regulate them effectively while balancing affordability and domestic manufacturing interests.

Background and Context

India’s healthcare sector is expanding rapidly, yet access to advanced diagnostic equipment remains uneven across regions.

High-end medical devices such as:

• MRI machines,
• CT scanners,
• PET-CT systems,
• Robotic surgical systems,

are capital-intensive and often unaffordable for smaller hospitals.

Refurbished devices — previously used equipment restored to original operating standards — have emerged as a cost-effective alternative.

However, regulatory ambiguity and policy contradictions have created uncertainty regarding their import, licensing, and safety oversight.

About Refurbished Medical Devices

Refurbished medical devices are:

• Pre-owned equipment,
• Restored to meet original manufacturer specifications,
• Resold at lower prices compared to new equipment.

Cost Advantage

Refurbished devices offer substantial savings:

• 1.5T MRI: New ₹4–8 crore | Refurbished ₹1–3.5 crore
• PET-CT: New ₹20 crore+ | Refurbished ₹60 lakh–3.5 crore
• CT scanner: New ₹2–4 crore | Refurbished ₹20 lakh–2.5 crore

These price differences significantly improve access in Tier-2 and Tier-3 cities.

Dependence on Imports

India remains dependent on imports for advanced imaging systems due to:

• Technological complexity,
• Global supply chain dominance.

Refurbished equipment is typically sourced from:

• United States,
• Germany,
• Japan,
• Netherlands,

where hospitals upgrade systems before the end of their functional life.

Current Regulatory Framework

1. Absence of Specific Licensing Pathway

India does not have a separate regulatory framework for refurbished devices under the Medical Devices Rules, 2017.

All medical devices were notified as “drugs” under the Drugs and Cosmetics Act in 2020, but refurbished products lack a dedicated licensing mechanism.

2. Import Regulation via Waste Rules

Currently, imports are regulated under the Hazardous and Other Wastes (Management and Transboundary Movement) Rules, 2016.

Import approvals require:

• No-objection certificate from expert committees under the Ministry of Environment, Forest and Climate Change,
• Technical inputs from the Central Drugs Standard Control Organisation,
• Authorisation from the Directorate General of Foreign Trade.

3. Regulatory Inconsistency

• In November 2025, MoEFCC approved certain refurbished devices for reuse.
• In January 2025, CDSCO stated such imports cannot be sold due to absence of licensing provisions.

This created regulatory contradiction between environmental and medical regulators.

Industry Divide and Policy Debate

International Manufacturers’ View

The Medical Technology Association of India argues:

• Refurbished devices are regulated globally, not banned.
• They enhance affordability and healthcare access.
• They support skill training and service industries.

Domestic Manufacturers’ View

The Association of Indian Medical Device Industry contends:

• Lack of usage history clarity may pose safety risks.
• Shorter lifespan and performance variability.
• May undermine domestic manufacturing under Make in India.

Industry estimates suggest the refurbished segment is worth around ₹1,500 crore — nearly 10% of India’s medical equipment market.

Significance of the Proposed Regulatory Policy

1. Improving Healthcare Access

Refurbished devices reduce capital costs, enabling advanced diagnostics in smaller cities.

2. Strengthening Patient Safety

A dedicated framework can:

• Define performance standards,
• Ensure traceability,
• Mandate certification and testing.

3. Promoting Regulatory Clarity

Clear definitions distinguishing “used,” “refurbished,” “reconditioned,” and “remanufactured” devices will reduce compliance ambiguity.

4. Balancing Industrial Policy

Regulation must reconcile:

• Affordable healthcare access,
• Promotion of indigenous manufacturing under Make in India.

5. Supporting Sustainable Waste Management

Guidelines on disposal and end-of-life management prevent India from becoming a dumping ground for obsolete equipment.

Broader Policy Questions

• Should India prioritise affordability in the short term?
• Or focus on long-term technological self-reliance?
• How can regulation ensure safety without discouraging domestic innovation?

The committee’s recommendations will shape the future trajectory of India’s medical device ecosystem.