Revised List of High-End Used Medical Equipment for Import

Central Board of Indirect Taxes & Customs (CBIC) has issued Instruction No. 25/2024, which updates the list of high-end, high-value used and refurbished medical equipment permitted for import, excluding critical care items. The revised list includes 38 types of equipment, such as MRI, CT, robotic-assisted surgical systems, and high-end dental chairs, reflecting the latest amendments communicated by the Ministry of Environment, Forest and Climate Change (MOEFCC) as of October 15, 2024. Key conditions for importing this equipment mandate compliance with hazardous waste management rules, including the necessity of a minimum 7-year residual life for each item, certified by a chartered engineer or accredited agency. Additional requirements include a one-year warranty followed by a three-year Comprehensive Maintenance Contract (CMC), as well as documentation on employment impact and adherence to Extended Producer Responsibility (EPR) if relevant. Importers must also provide verification from the original equipment manufacturer (OEM) regarding the functionality, non-obsolescence, and absence of hazardous materials, as per international and Indian standards. Compliance with these guidelines is enforced through coordination with the Directorate General of Foreign Trade (DGFT) and state pollution control authorities, ensuring adherence to environmental safety and regulatory standards.

Instruction No. 25/2024-Customs | Dated: 28.10.2024

F.No.401/40/2021-Cus.III
Government of India
Ministry of Finance, Department of Revenue
(Central Board of Indirect Taxes & Customs)
Room No. 229A, North Block, New Delhi,
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To
All Principal Chief Commissioners/ Chief Commissioners of Customs/Customs
(Preventive) /Customs and Central Taxes
All Principal Commissioners/ Commissioners Customs/ Customs (Preventive)
All Principal Director Generals/Director Generals under CBIC

Subject: Revised List of High End and High Value used/refurbished Medical Equipment other than critical case medical equipment – reg

Madam/Sir,

Reference is invited to Ministry of Environment, Forest and Climate Change (MOEFCC) (HSM Division) O.M. dated 15.10.2024, with Annexure ‘I’, on the above subject (copy enclosed).

2. Vide above O.M. dated 15.10.2024, MOEFCC has stated that in supersession of Ministry’s O.M. of even no. dated 19.06.2023 and in reference to the Directorate General of Health Services (DGHS), Ministry of Health & Family Welfare (MoHFW) OM dated 20.08.2024 forwarding therewith revised list of High End and High Value used/refurbished Medical Equipment, the list of High End and High Value used/refurbished Medical Equipment other than critical care medical equipment has been revised.

3. In this regard, in partial modification of Instruction No. 08/2024-Customs dated 05.04.2024, a revised list of 38 High End and High Value used/refurbished Medical Equipment other than critical care medical equipment is as below;

4. It is requested that necessary action may be taken to sensitize officers under your jurisdiction regarding the said matter. The difficulties, if any, may be brought to the notice of the Board.

Hindi version follows.

Yours faithfully,

Encl.: as stated above.

(Neeraj Goyal)
OSD (Cus-III)
Customs Policy Wing
Email: [email protected]
Tele: 011 23094012

F.No. 23/104/2022-HSMD
Government of India
Ministry of Environment, Forest and Climate Change
(HSM Division)

Jal Block, ^2nd Floor,
Indira Paryavaran Bhawan,
Jor Bagh Road, Aliganj,
New Delhi – 110003

Dated: 15th October, 2024

Subject: Revised List of High End and High Value used/refurbished Medical Equipment other than critical care medical equipment- reg.

In super session of the Ministry’s OM of even No. dated 19^th June, 2023 and in reference to the Directorate General of Health Services (DGHS), Ministry of Health & Family Welfare (MoHFW) OM dated 20^th August, 2024 forwarding therewith revised list of High End and High Value. used/refurbished Medical Equipment, the revised list ,,of High End and High Value used/refurbished Medical Equipment other than critical care Medical equipment is as follows:

2. The revised list of High End and High Value used Medical Equipment other than critical care medical equipment will be in force from the date of issue of this OM. Other Conditions for obtaining import permission of used/refurbished High End High value medical equipment as prescribed by the Technical Review Committee (TRC)/ Expert Committee (EC) constituted in the Ministry in its earlier meeting, shall remain the same and are attached at Annexure ‘I’.

This issues with the approval of the Competent Authority.

(Ved Prakash Mishra)
Director

To,

1. The Joint Secretary,
Department of Health & Family Welfare,
Ministry of Health & Family Welfare,
Nitinan Bhawan, New Delhi – 110001.

2. The Deputy Director General,
Directorate General Health Services,
Department of Health & Family Welfare,
Ministry of Health & Family Welfare,
Nimian Bhawan, New Delhi – 110001.

3. The Director General,
Directorate General of Foreign Trade,
Udyog Bhawan, H-Wing, Gate No.2,
Maulana Azad Road, New Delhi – 110011,

4. The Director (Customs),
Ministry of Finance,
Department of Revenue, Central Board of Excise and Customs,
North Block, New Delhi – 110 001.

Annexure ‘I’

Import of used/refurbished High End High value medical equipment

a. Conditions/Pre-requisites for Import of used/refurbished High End High value medical equipment:

• Form 5 of Hazardous and Other Wastes (Management and Transboundary Movement) Rules, 2016 as amended from time to time.
• The equipment must be enlisted iii Ministry’s O.M. dated 19^th June, 2023, as advised by DGHS.
• Justification for import.
• The High End High Value Used/refurbished Medical Devices having residual life of minimum 07 years, duly certified by a Chartered Engineer or a certificate from any accredited agency of exporting country indicating the functionality, manufacturing date, residual life and serial number, shall be allowed for import for reuse purpose.
• If being imported or returnable basis than undertaking for re-export, then specifying the time period.
• Details of previous -import if there has been o qy and confirmation regarding their re­export.
• In case of capital items particularly medical equipment the fact that the machine has been refurbished at the OEM factory and after sales service is provided by the supplier/ importer.
• Acknowledgment for receipt of copy of import application from concerned State Pollution Control Board (SPCB)/ Pollution Control Committee (PCC).
• Certification from exporting company for accepting the re-export of defective or second hand EEEs, after the specified time.
• Document depicting the status of employment generation indicating the no. of people benefited.
• Extended Producer Responsibility – registration as producer if the EEEs to be imported are listed in Schedule-I of the E-Waste (Management) Rules, 2022 as amended from time to time.
• Copy of the previous latest permission issued by this Ministry, if any.
• Undertaking declaring that such equipment has not been phased out from the importing country and is not considered obsolete in that country.
• Undertaking declaring that such equipment does not contain any hazardous material/ substances listed under any international regulation/ law and or by government of India.
• OEM/Indian subsidiary of that equipment shall ensure the availability of hardware and software support including spare parts/consumables for the period of warranty and comprehensive maintenance contract (CMC).
• Equipment should have minimum warranty period of one year, followed by three years of CMC.
• OEM/Indian subsidiary must give in writing about the availability of spare parts/consumables.
• The equipment shall be disposed after the end of life as per the prevailing Hazardous and Other Wastes (Management & Transboundary Movement) Rules, 2016 as amended from time to time and E-Waste (Management) Rules, 2022 as amended from time to time.
• The importer has to obtain an import authorization from DGFT, wherever the import policy of such items is restricted under ITC(HS)/Foreign Trade Policy/Procedures and any other statutory NOC/clearances as applicable.
• The Customs Authority at the Air Cargos/Ports/ICDs shall verify the documents r:rior to clearing the consignments. They can also take action as per the Hazardous and Other Wastes (Management and Transboundary Movement) Rules, 2016 as amended from time to time and the Customs Act, 1962 against importers found to be violating the norms.

b. In case import application is made by third party on behalf of actual user, List/Mapping of End Users for each equipment must be provided and confirmed purchase order from end user should be available.

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