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.

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.