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High-Value Medical Equipment: Customs Exemptions

High-Value Medical Equipment: Customs Exemptions

High-Value Medical Equipment: Customs Exemptions

In June last year, the Union government issued a notification that allowed the import of refurbished medical devices, excluding critical care equipment, into India. This policy decision authorized the importation of 50 types of high-end and high-value devices, such as MRI and CT scan machines. The decision created a split within the medical devices industry: multinational corporations welcomed the move for broadening access to advanced technologies, especially in tier 2 and tier 3 cities, while domestic manufacturers voiced concerns about undermining the ‘Make in India’ initiative and threatening local manufacturing.

Building on these changes, the CDSCO (Central Drugs Standard Control Organization) and the Central Board of Indirect Taxes & Customs issued a new circular dated April 5, 2024, identified as “F.No.401/40/2021-Cus.III.” This directive marks a significant shift in the regulatory framework for importing used high-end medical equipment into India. It aims to streamline the import process while enforcing strict compliance with safety and environmental standards. This notification states that Used Critical Care Equipment is covered under Basel N. B1110 of Schedule VI of the HOWM Rules and is prohibited for import and reuse. The list is the same as the 14 critical care equipments mentioned below under F. No. 23/104/2022 – Released on May 19, 2023

Review of previous circulars –
1. F. No. 23/104/2022 – Released on May 19, 2023

The Ministry of Environment, Forest and Climate Change (MOEFCC) has updated the Hazardous and Other Wastes (Management and Transboundary Movement) Second Amendment Rules, 2022, dated 13th October updated the list of critical care medical equipment. The rule states that import/export of hazardous and other wastes are regulated through the HOWM Rules, 2016 and prohibited for import for re-use.

List of Prohibited Critical Care Medical Equipment:

    1. High End Ventilators

    2. Nitric Oxide Generators

    3. Flexible Bronchoscopes

    4. ABG Machines

    5. Haemodialysis Machines

    6. Continuous Renal Replacement Therapy (CRRT)

    7. CO, SVR, ScvO2 Monitors

    8. Intubating Videoscopes

    9. ICU dedicated Ultrasound and Echo Machines

    10. Bedside X-ray Machines

    11. Extra-Corporeal Membrane Oxygenators (ECMO)

    12. Intra-Aortic Balloon Pumps (IABP)

    13. Percutaneous Dilatation Tracheostomy Kits

    14. Defibrillators with Transcutaneous Pacemakers

    2.  F. No. 23/104/2022 – Released on June 19, 2023

    The Ministry of Environment, Forest and Climate Change updated the regulations on December 23, 2022, with the Hazardous and Other Wastes (Management and Transboundary Movement) Second Amendment Rules, 2022. These amendments specifically include high-end and high-value used medical equipment, other than used critical care medical devices, in Part ’13’ of Schedule III of the 2016 Rules. The import of such equipment is permitted for actual users, Original Equipment Manufacturers (OEMs), their Indian subsidiaries, or traders acting on behalf of the actual users for reuse purposes. Additionally, the definition of “High End and High Value Medical Equipment” will be specified by the Ministry of Health and Family Welfare as needed.

    List of Permissible High-End and High-Value Used Medical Equipment for Import

    This table outlines the high-end and high-value used medical equipment approved for import, as designated by the Directorate General of Health Services under the Ministry of Health & Family Welfare.

    S.No.
    Name of Equipment
    1 MRI
    2 CT
    3 PET-CT
    4 SPECT/SPECT-CT/Gamma camera
    5 Mammography
    6 High end X-ray – Non-ICU
    7 Ultrasound — Non-ICU
    8 Interventional Radiology equipment
    9 C — arm (surgery)
    10 Radiotherapy Device
    11 Microbiology — Microbial identification & AST
    12 Microbiology – detecting systems for microorganisms in blood, sterile body fluids
    13 Multi parametric immunoassay Analyzer (ELFA technology)
    14 Molecular diagnostic — molecular infectious disease diagnostics systems
    15 Microbiology — advanced mass spectrometry microbial identification system
    16 Blood cell count analyzer
    17 Microscope slide maker/stainer
    18 Chemiluminescent immunoassay analyzer
    19 Clinical chemistry analyzer
    20 Immunohematology Auto Analyzer
    21 URINE Analyzers
    22 Robotic Assisted surgical system, instruments and accessories
    23 Femtosecond ophthalmic solid-state laser system
    24 Phacoemulsification and vitrectomy system
    25 Ophthalmic -Excimer Laser system
    26 OCT posterior and anterior segment
    27 Fundus imaging system, preferably ultrawide field along with FFA and ICG
    28 Corneal topography
    29 Optical biometer
    30 Clinical corneal specular microscope
    31 High end operating microscope
    32 Ablation system
    33 Endoscopic Camera system
    34 Endoscopes
    35 Orthopedic Robotic Navigation system
    36 Medical-grade monitors
    37 Image Management system
    38 Medical-grade electromechanical drill
    39 Flow control pump
    40 Insufflation device
    41 NCV/EMG system
    42 EEG system
    43 Repetitive transcranial magnetic stimulator
    44 Flexible video Ureterorenoscope with Monitor
    45 Video Urodynamic system with chair
    46 CryoAblation system
    47 4K Advance Laparoscopy surgery system
    48 OT integration system
    49 High intensity Focused Ultrasound system
    50 3D – 4K Laparoscopy system

    3. F. No.23/ 1 04/2022 6th July, 2023

    The Ministry has revised its import policies for high-end and high-value used medical equipment, excluding critical care devices, to enhance access for smaller healthcare facilities in Tier II and III cities. This change comes in response to inquiries about the import and use of refurbished items like Robotic Assisted Surgical Systems. The revised policy mandates that equipment must not be obsolete or hazardous according to international and national standards, have a minimum residual life of seven years with required support and warranty, and comply with e-waste disposal rules at its life’s end. Subsequent modifications to the Hazardous and Other Wastes (Management and Transboundary Movement) Rules, 2016, support these import processes. The Directorate General of Health Services also provided a list on June 5, 2023, detailing approved equipment and emphasizing the non-importation of items manufactured domestically to support the “Make in India” policy. An Expert Committee of the Ministry now oversees import permissions, ensuring compliance with conditions and national initiatives like “Make in India” and “Atmanirbhar Bharat.” This streamlined approach aims to improve healthcare infrastructure while upholding safety and environmental standards, with the final approval from the competent authority.

    4. F. No.23/ 1 04/2022 15th December, 2023

    The recent communication reiterates the policy on importing high-end and high-value used/refurbished medical equipment, excluding critical care devices, as outlined in the June 19, 2023, OM. It’s emphasized that only actual users, OEMs, their Indian subsidiaries, or authorized traders can import these items for reuse. All such imports are classified under Schedule III Part ‘B’ of the HOWM Rules, 2016, making them subject to stringent restrictions and requiring explicit permission from the Ministry of Environment, Forest and Climate Change. This directive supersedes all previous OMs, rendering any permissions granted before June 19, 2023, as invalid. Official endorsements from competent authorities accompany this update.

    Conclusion

    The directives from the Central Board of Indirect Taxes & Customs and the Ministry of Environment, Forest, and Climate Change signify a progressive shift in regulating the importation of medical devices into India. These changes underscore the government’s commitment to improving healthcare access while ensuring safety and environmental sustainability. From assisting with CDSCO registration to ensuring compliance with MD-14 guidelines, Morulaa offers expert guidance at every step.With the support of Morulaa HealthTech, medical device manufacturers and importers can navigate this evolving regulatory landscape with ease and confidence, ensuring their products meet the stringent standards set forth by Indian regulatory authorities. For more information on how Morulaa can help you adapt to these regulatory changes, reach out to us at [email protected] or click here to learn more.

    CDSCO’s Role in Regulatory Compliance

    The Central Drugs Standard Control Organization (CDSCO) plays an important role in regulating the import and export of medical devices in India. Adhering to the guidelines set by CDSCO ensures that medical devices meet the necessary safety and efficacy standards. With the MD-14 and SUGAM portals, the process of medical device registration and compliance has become more streamlined. This enables manufacturers to focus on innovation while ensuring their products adhere to regulatory requirements. The SUGAM portal is an essential tool for medical device registration in India. It simplifies the submission and tracking of regulatory documents, ensuring that manufacturers stay compliant with CDSCO guidelines. By using the SUGAM portal, medical device companies can ensure their products are registered correctly and efficiently, minimizing delays in bringing new technologies to market.

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