In an important development, importation of used/ refurbished medical devices into India have been restricted by Central Drugs Standard Control Organisation (CDSCO). CDSCO is the central authority to regulate importation of drugs and medical devices under the Drugs and Cosmetics Act, 1940. In a letter dated 10 January 2025, issued by CDSCO to the Indian Customs Authorities, CDSCO has clarified that refurbished medical devices cannot be imported into India for sale and distribution purposes as there is no specific regulation under the Medical Devices Rules, 2017.
In the past, importation of refurbished devices was allowed post enactment of Hazardous and Other Wastes (Management and Transboundary Movement) Second Amendment Rules by the Ministry of Environment, Forest and Climate Change. Pursuant to these rules, the Directorate General of Health Services specified a list of 50 high end and high value pre-owned and refurbished medical devices that could be imported into India, subject to fulfillment of certain conditions and pre-requisites. Later, the list was reduced to 38 devices vide the Office Memorandum issued by Ministry of Environment, Forest, and Climate Change dated 15 October 2024.
For domestic manufacturers, this was a long-standing demand to prohibit the influx of unregulated pre-owned and refurbished medical devices and support the 'Make in India' initiative. However, concerns are also being raised that this sudden ban on imports will impact availability of medical devices especially in Tier II, Tier III, and Tier IV cities, as well as rural and underserved areas. Given this, the Medical Technology Association of India has highlighted the need for a suitable policy/ regulation to address this issue. It is understood that the Ministry of Health is working to constitute a high-level expert committee to discuss regulatory aspects and suggest a roadmap to allow future importation of refurbished medical devices in India. Till then, it is likely that the importation will remain suspended.
Originally published 30 January, 2025.
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