Centre issues revised list of refurbished medical equipment for import; industry reacts sharply

The Centre has issued a revised list of high-end and high-value used/refurbished medical equipment for import.

MRI, CT, PET-CT, and radiography devices have been included in the 38-item revised list issued by the Union Ministry of Environment, Forest, and Climate Change (MoEFCC).

The ministry said the revised list will be in force from the date of issue of the office memorandum (OM). Other Conditions for obtaining import permission for used/refurbished high-end high-value medical equipment as prescribed by the Technical Review Committee/ Expert Committee, shall remain the same.

The conditions and pre-requisites for the import of used refurbished high-end high-value medical equipment include:
Form 5 of Hazardous and Other Wastes (Management and Transboundary Movement) Rules, 2016 as amended from time to time.

The equipment must be enlisted in the Ministry’s O.M. dated 19th June 2023, as advised by DGHS.

Justification for import
The high-end high-value used/refurbished medical devices having a residual life of a minimum of 07 years, duly certified by a Chartered Engineer or a certificate from any accredited agency of the exporting country indicating the functionality, manufacturing date, residual life, and serial number, shall be allowed for import for reuse purpose.

Details of previous imports if there have been any and confirmation regarding their re-export.

In the 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 a copy of the import application from the 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 a 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 the 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 a 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 of 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 before 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.

“In case import application is made by a 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,” said the Ministry.

Industry reacts:
The medical device industry has reacted sharply to the Centre’s new move. “The growing trend of importing refurbished or pre-owned medical equipment poses challenges to the growth of domestic manufacturers, risks to patient safety, and raises concerns about the reliability and effectiveness of these devices. The MedTech industry and healthcare associations have had several meetings with the ministry to advocate for a ban on refurbished/ pre-owned medical equipment imports. However, recent orders issued by the Ministry of Environment, Forest, and Climate Change (MoEFCC) and the Directorate General of Health Services (DGHS), which excluded the ‘Make in India’ preference for similar products manufactured domestically, have caused significant distress within the industry. This decision has sparked concerns about India’s efforts to build a self-reliant medical device manufacturing ecosystem. The shift has serious repercussions, particularly for MedTech start-ups, which have invested substantial resources in realizing the Prime Minister’s ‘Make in India’ vision,” 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 

MB Bureau