Refurbished Medical Devices in India: Access vs. Regulation

Syllabus: GS2/Issues Related To Health

Context

• The import of refurbished high-end medical equipment has major implications for healthcare access, industry policy, and patient safety.

What Are Refurbished Medical Devices?

• Refurbished medical devices are previously used systems that have been restored to their original operating specifications and resold at significantly lower prices.
• These are typically capital-intensive machines used in advanced diagnostics and surgery.
• Examples include MRI scanners (Magnetic Resonance Imaging); CT scanners (Computed Tomography); PET-CT systems (Positron Emission Tomography–CT); Advanced endoscopy and laparoscopy units; and Robotic navigation and surgery systems;

• For hospitals in Tier-2 and Tier-3 cities, district centres, and standalone diagnostic facilities, these savings can determine whether advanced diagnostics are available locally at all.

Current Regulatory Landscape in India

• No Dedicated Regulatory Pathway: India currently lacks a specific regulatory framework governing refurbished devices under the Medical Devices Rules, 2017.
• In 2020, all medical devices were notified as ‘drugs’ under the Drugs and Cosmetics Act, expanding central oversight, but no specific licensing pathway was created for refurbished products.

How Imports Are Currently Allowed?

• Imports of used medical equipment are governed primarily under the Hazardous and Other Wastes (Management and Transboundary Movement) Rules, 2016. Under amendments introduced in December 2022:
  • Certain high-end used devices may be imported.
  • Prior permission is required from the MoEFCC.
  • Maintenance history, quality assurance reports, and compliance documentation must be submitted.
  • Technical input from the Central Drugs Standard Control Organisation (CDSCO) is required.
  • Import authorisation from the Directorate General of Foreign Trade (DGFT) is mandatory.
• Regulatory Issues: CDSCO, in January 2025, stated refurbished devices cannot be imported for sale or distribution because there is no licensing provision under the Medical Devices Rules.
• However, in November 2025, a technical expert committee under MoEFCC cleared multiple refurbished devices, including CT scanners, MRI systems, and robotic surgical units for reuse. This created a legal inconsistency:
  • MoEFCC approval under waste rules;
  • CDSCO prohibition under medical device laws;
• Import Dependency: India continues to depend heavily on imports for high-end imaging technologies due to complex manufacturing requirements, including precision detectors, advanced software systems, and sophisticated supply chains.
  • Refurbished equipment is typically sourced from developed markets such as the US, Germany, Japan, and the Netherlands, where hospitals upgrade equipment before its full functional life ends.

New Policy Committee

• The Department of Pharmaceuticals informed the Rajya Sabha that the Ministry of Health and Family Welfare, in February 2026, has constituted a committee to develop a formal policy on refurbished medical devices.
• The committee aims to:
  • define what qualifies as ‘refurbished’;
  • develop methods to evaluate safety, performance, and remaining useful life;
  • recommend guidance on waste disposal;
  • examine regulatory alignment;

Stakeholder Perspectives

International Manufacturers (MTAI): The Medical Technology Association of India (MTAI), representing over 50 international manufacturers, argues that:

• A blanket ban would hurt affordability.
• India needs a globally aligned, time-bound policy.
• Refurbished devices should be allowed only through original equipment manufacturers (OEMs) to ensure legal accountability, proper servicing, and patient safeguards.
• MTAI maintains that refurbished equipment:
  • Expands access in smaller cities;
  • Supports healthcare worker training goals;
  • Aligns with India’s export ambitions for healthcare professionals;

Domestic Manufacturers (AiMeD): The Association of Indian Medical Device Industry (AiMeD) strongly opposes relaxing restrictions without a robust framework aligned with international regulatory standards.

• Their concerns include unknown usage histories, inconsistent performance, limited traceability, shorter remaining lifespan, and risk of India becoming a ‘dumping ground’.
• AiMeD argues that legalising imports could undermine ‘Make in India’ initiatives and weaken preparedness during future health emergencies.

Way Ahead: What Happens Next?

• The government’s policy committee will need to establish a clear legal definition, align environmental and medical regulations, create a licensing pathway under Medical Devices Rules, define quality, testing, and lifespan standards, and ensure transparency for buyers and patients.
• If crafted carefully, the framework could improve patient safety, expand affordable access, support domestic industry, and ensure regulatory coherence.
• The outcome will shape India’s diagnostic infrastructure and its long-term medical technology ambitions.

Source: IE