In this update, we have provided the revised list of refurbished medical equipment for import provided by the Centre. Additionally, we have listed the major conditions for importing refurbished medical equipment into India.

Revised list of refurbished medical equipment for import

1. Corneal Topography
2. Optical Biometer
3. High-End Operating Microscope
4. Ablation System
5. Orthopaedic Robotic Navigation System
6. High-End Medical-Grade Monitors
7. Image Management System
8. MRI
9. CT
10. PET-CT
11. SPECT/SPECT-CT/Gamma Camera
12. Mammography
13. Interventional Radiology Equipment
14. Radiotherapy Devices
15. Molecular Diagnostic System
16. Advanced Mass Spectrometry Microbial Identification System
17. Robotic Assisted Surgical System and Accessories
18. Femtosecond Ophthalmic Solid-State Laser System
19. Phacoemulsification and Vitrectomy System
20. Ophthalmic Excimer Laser System
21. OCT Posterior and Anterior Segment
22. Fundus Imaging System (preferably ultrawide field)
23. NCV/EMG System
24. EEG System
25. Repetitive Transcranial Magnetic Stimulator
26. Video Urodynamic System with Chair
27. Cryo Ablation System
28. Endoscopic Camera System
29. Endoscopes
30. High-Intensity Focused Ultrasound System
31. 3D-4K Laparoscopy System
32. High-End Dental Chair
33. Cone-Beam Computed Tomography Systems (CBCT)
34. Medical-Grade Electromechanical Drill
35. Flow Control Pump
36. Insufflation Device

Prerequisites for refurbished medical equipment for import

Certain conditions and prerequisites have to be fulfilled for importing refurbished medical equipment. Compliance with previously established Technical Review Committee and Expert Committee conditions is required.

Major requirements

• Eligibility criteria: The medical equipment must be listed in the Ministry’s O.M. dated June 19, 2023, as per Directorate General of Health Services (DGHS) advice.
• Justification for import: The high-end/high-value refurbished medical devices should have a minimum residual life of 7 years. This should be certified by a Chartered Engineer or an accredited agency of the exporting country. Details, such as functionality, manufacturing date, residual life, and serial number, have to be mentioned.
• Employment generation documentation: The device importers are required to provide documentation that will indicate the impact of the import on employment generation.
• Previous import details: Importers are required to provide information regarding past imports and confirmation of their re-export.

• Safety declarations: Importers have to declare the device to be imported has not been phased out in the exporting country. Additionally, the device importers will have to declare the device does not contain any hazardous materials as per international regulations or Indian law.
• Compliance with hazardous waste regulations: Importers are required to submit Form 5 under the Hazardous and Other Wastes (Management and Transboundary Movement) Rules, 2016, as amended.
• Prior permissions: A copy of any previous permissions for the medical device that was issued by the Ministry must be provided.
• OEM refurbishment verification: For capital medical devices, a verification is required that the machines have been refurbished at the Original Equipment Manufacturer (OEM) factory, with after-sales service offered by the importer or supplier.
• State pollution control board acknowledgment: Acknowledgment from the relevant State Pollution Control Board or Pollution Control Committee is required.
• Extended producer responsibility registration: If the imported medical device is listed in Schedule-I of the E-Waste (Management) Rules, 2022, registration as a producer is mandatorily required.

Warranty and support requirements for refurbished medical equipment for import

• The refurbished medical equipment for import must have a minimum warranty period of 1 year. Additionally, the warranty period should be followed by a comprehensive maintenance contract (CMC) of 3 years.
• The OEM or the Indian subsidiary has to ensure the availability of spare parts, hardware, and software support throughout the warranty and CMC period.

Requirements for import applications submitted by a third party

If the medical device import application is submitted by a third party, a list/mapping of end users for each equipment item has to be provided. Additionally, a confirmed purchase order from the end user is required.

Import authorization and compliance

For importing refurbished medical equipment that are restricted under the ITC(HS)/Foreign Trade Policy/Procedures, an authorization from the Directorate General of Foreign Trade (DGFT) will be required. Moreover, customs authorities at ports or air cargo facilities will check for compliance before clearing the consignment. Furthermore, they can take action against any violations.

Pharmadocx Consultants will help you easily import medical devices

We provide comprehensive services for medical device importers. Our team has extensive knowledge of the CDSCO regulatory guidelines for importing medical devices. We will streamline the medical device import license application process. Additionally, we will help you prepare the necessary documents for license application. Moreover, we also provide Indian authorised agent service. With our all-encompassing support, you can easily import your medical devices into India. Call/Whatsapp on 9996859227 or drop an email at [email protected] to get expert support.