India is framing a policy to regulate refurbished medical devices to resolve conflicts between environmental and health regulators. Refurbished devices—previously used equipment restored to Original Equipment Manufacturer (OEM) standards—can expand affordable diagnostics but raise safety and domestic industry concerns.

About Refurbished Medical Devices
- Refurbished medical devices are used equipment restored to certified safety and performance standards.
- High-value examples include MRI scanners, CT scanners, PET-CT systems, and robotic surgery platforms.
- They cost nearly 50–60% less than new equipment, improving affordability for hospitals in Tier-2 and Tier-3 cities.
- Refurbishing extends device life cycles and supports the circular economy by reducing e-waste.
Current Regulatory Framework in India
- The Medical Devices Rules (MDR), 2017 do not define or regulate refurbished devices.
- Imports fall under Hazardous and Other Wastes Rules, 2016 (MoEFCC).
- Import permitted for 38 items if residual life ≥7 years and warranty provided.
- Regulatory conflict: MoEFCC allows imports but CDSCO often blocks approvals citing safety gaps.
Arguments Supporting Regulated Imports
- Healthcare Access: Lower capital costs improve diagnostic availability in underserved regions.
- Global Practice: Refurbished device regulation exists in the EU and USA under certified reprocessing norms.
- Medical Training: Enables affordable acquisition of advanced equipment by medical colleges.
- Sustainability: Reduces electronic waste and supports resource efficiency.
Concerns Against Refurbished Imports
- Safety Risks: Unknown usage history and calibration inconsistencies may affect clinical reliability.
- Industry Impact: Cheaper imports may undermine domestic manufacturing and PLI incentives.
- Dumping Risk: India may become a destination for obsolete medical equipment.
- Regulatory Gap: Lack of traceability and lifecycle data weakens post-market surveillance.
Policy Significance
A dedicated regulatory pathway under MDR can harmonise health safety standards (CDSCO) with environmental import rules (MoEFCC). Standardised refurbishment certification, device traceability, and performance validation can enable safe adoption while supporting domestic industry growth.
Way Forward
- Define refurbished devices and create a separate approval pathway under MDR.
- Mandate OEM-certified refurbishment and lifecycle tracking.
- Establish performance testing and post-market surveillance protocols.
- Align import policy with “Make in India” and PLI objectives.









