Centre Approves Revised List of Refurbished Medical Equipment for Import
The Centre has announced a revised list of refurbished medical equipment approved for import, which now includes high-end devices such as MRI, CT, PET-CT, and various radiography devices. This 38-item list has been issued by the Union Ministry of Environment, Forest, and Climate Change (MoEFCC) and will take effect immediately upon the release of the office memorandum (OM).
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Import Conditions and Prerequisites
The importation of high-value, used, or refurbished medical equipment will continue to adhere to the conditions previously established by the Technical Review Committee and the Expert Committee. Key prerequisites include:
- Compliance with Hazardous Waste Regulations: Importers must submit Form 5 under the Hazardous and Other Wastes (Management and Transboundary Movement) Rules, 2016, as amended.
- Eligibility Criteria: Equipment must be listed in the Ministry’s O.M. dated June 19, 2023, following advice from the Directorate General of Health Services (DGHS).
- Justification for Import: High-end refurbished medical devices should have a minimum residual life of 7 years, certified by a Chartered Engineer or an accredited agency in the exporting country, including details like functionality, manufacturing date, residual life, and serial number.
- Previous Import Details: Importers must provide information about any past imports and confirmation of their re-export.
- OEM Refurbishment Verification: For capital medical equipment, verification that machines have been refurbished at the Original Equipment Manufacturer (OEM) factory, with after-sales service offered by the supplier or importer, is required.
- State Pollution Control Board Acknowledgment: Acknowledgment of receipt from the relevant State Pollution Control Board (SPCB) or Pollution Control Committee (PCC) is necessary.
- Employment Generation Documentation: Importers must present documentation that reflects the impact on employment generation from these imports.
- Extended Producer Responsibility Registration: If the imported equipment is listed in Schedule-I of the E-Waste (Management) Rules, 2022, registration as a producer is mandatory.
- Prior Permissions: A copy of any previous permissions issued by the Ministry must be provided.
- Safety Declarations: Importers must declare that the equipment has not been phased out in the exporting country and does not contain hazardous materials as per international regulations or Indian law.
Warranty and Support Requirements
- Equipment must come with a minimum warranty period of one year, followed by a comprehensive maintenance contract (CMC) of three years.
- The OEM or Indian subsidiary is required to ensure the availability of hardware, software support, spare parts, and consumables throughout the warranty and CMC period.
Import Authorization and Compliance
Importers must obtain authorization from the Directorate General of Foreign Trade (DGFT) if the import policy restricts such items under the ITC(HS)/Foreign Trade Policy/Procedures. Customs authorities at ports and air cargo facilities will verify compliance before clearing consignments and can take action against any violations.
Third-Party Import Applications
If an import application is submitted by a third party, a List/Mapping of End Users for each equipment item must be provided along with a confirmed purchase order from the end user.
Industry Response
The medical device industry has expressed significant concerns regarding the Centre’s revised policy. “The increasing trend of importing refurbished or pre-owned medical equipment threatens the growth of domestic manufacturers and raises patient safety risks. The MedTech industry and healthcare associations have actively lobbied for a ban on these imports. Recent orders from the MoEFCC and DGHS have excluded ‘Make in India’ preferences for domestically manufactured products, causing distress within the industry,” said the PHD Chamber of Commerce and Industry and AiMed in a joint statement.
Complete Revised List of High-End and High-Value Used/Refurbished Medical Equipment
- 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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