Centre Releases Revised List of Refurbished Medical Equipment for Import
The Government of India has officially released the updated List of Refurbished Medical Equipment, allowing the import of high-end devices under strict regulatory conditions. This revised list, issued by the Ministry of Environment, Forest, and Climate Change (MoEFCC), includes 38 advanced medical devices such as MRI, CT scanners, PET-CT systems, and robotic surgical equipment.
This move aims to improve healthcare accessibility while maintaining strict compliance standards for safety, performance, and environmental impact.
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Key Import Conditions for Refurbished Medical Equipment
To ensure safe and regulated imports, authorities have defined strict compliance requirements:
1. Regulatory Compliance Requirements
- Mandatory submission of Form 5 under Hazardous Waste Rules, 2016
- Compliance with updated environmental and e-waste regulations
- Adherence to DGHS-recommended equipment eligibility
2. Residual Life & Certification
- Minimum 7 years of residual life required
- Certification by a Chartered Engineer or accredited agency
- Details must include manufacturing date, serial number, and functionality
3. OEM Refurbishment Verification
- Equipment must be refurbished at the Original Equipment Manufacturer (OEM) facility
- Availability of after-sales service support is mandatory
4. Environmental & Legal Approvals
Acknowledgment from State Pollution Control Board (SPCB)
Mandatory EPR registration for e-waste listed devices
Declaration confirming:
- Equipment is not phased out globally
- No hazardous material present
5. Import Authorization
- Approval from DGFT required for restricted items
- Customs authorities will verify compliance at ports
Warranty, Maintenance & Support Requirements
To ensure long-term usability and patient safety:
Minimum 1-year warranty
Mandatory 3-year Comprehensive Maintenance Contract (CMC)
OEM must ensure:
- Spare parts availability
- Software & hardware support
- Consumables supply
Third-Party Imports: Additional Requirements
For third-party importers:
- Submit end-user mapping list
- Provide confirmed purchase orders
- Maintain transparency in usage and deployment
Complete List of Refurbished Medical Equipment Approved
The updated List of Refurbished Medical Equipment includes:
- MRI
- CT
- PET-CT
- SPECT/SPECT-CT/Gamma Camera
- Mammography
- Interventional Radiology Equipment
- Radiotherapy Devices
- OT Integration System
- 4K Advanced Laparoscopy Surgery System
- Molecular Diagnostic System
- Advanced Mass Spectrometry Microbial Identification System
- Robotic Assisted Surgical System and Accessories
- Femtosecond Ophthalmic Solid-State Laser System
- Phacoemulsification and Vitrectomy System
- Ophthalmic Excimer Laser System
- OCT Posterior and Anterior Segment
- Fundus Imaging System (preferably ultrawide field)
- Corneal Topography
- Optical Biometer
- High-End Operating Microscope
- Ablation System
- Endoscopic Camera System
- Endoscopes
- Orthopaedic Robotic Navigation System
- High-End Medical-Grade Monitors
- Image Management System
- Medical-Grade Electromechanical Drill
- Flow Control Pump
- Insufflation Device
- NCV/EMG System
- EEG System
- Repetitive Transcranial Magnetic Stimulator
- Video Urodynamic System with Chair
- Cryo Ablation System
- High-Intensity Focused Ultrasound System
- 3D-4K Laparoscopy System
- High-End Dental Chair
- Cone-Beam Computed Tomography Systems (CBCT)
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For Expert Guidance on Navigating the Import of Refurbished Medical Equipment
How Operon Strategist Helps with Importing Refurbished Medical Equipment
With the latest update on the List of Refurbished Medical Equipment, navigating regulatory requirements has become more complex for importers and healthcare businesses. Operon Strategist, as a trusted regulatory consulting partner, helps you understand the impact of these new government policies and ensures your import strategy aligns with current compliance standards.
At Operon Strategist, we provide end-to-end regulatory and compliance support for importing refurbished medical equipment. Our expert team helps you navigate complex regulations and ensures smooth approvals.
Our Key Services Include:
- Medical Device Import Licensing & DGFT Authorization Support
- Regulatory Consulting for CDSCO Registration & Compliance
- ISO 13485 QMS Implementation & Documentation
- Technical File & Regulatory Documentation Preparation
- EPR Registration & Environmental Compliance
- Medical Device Facility Setup & Turnkey Consulting
With our deep industry expertise, we help you reduce regulatory risks, ensure compliance, and accelerate market entry.
Contact Operon Strategist today to streamline your refurbished medical equipment import process.
FAQs
What is the List of Refurbished Medical Equipment?
It is a government-approved list of high-end used medical devices allowed for import under strict regulatory conditions in India.
Is importing refurbished medical equipment allowed in India?
Yes, but only for devices included in the approved list and subject to compliance with environmental, safety, and regulatory requirements.
What is the minimum residual life required for imported equipment?
A minimum of 7 years residual life is mandatory.
Is OEM certification required for refurbished devices?
Yes, equipment must be refurbished at OEM facilities with proper certification and service support.
Who issues the List of Refurbished Medical Equipment in India?
The list is issued by the Ministry of Environment, Forest, and Climate Change (MoEFCC) based on recommendations from the Directorate General of Health Services (DGHS).
