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MNCs Push Indian Authorities to Revive Refurbished Medical Device Imports, Seek Inclusion in Repair Pilot
In recent months, India halted the import of refurbished medical equipment, following directives that such devices lack clear regulatory provisions under the Medical Devices Rules of 2017. The Central Drugs Standard Control Organisation (CDSCO) instructed Customs to reject imports in the absence of specific licensing for these pre-owned devices.
- By Newsdesk
- New Delhi
- Aug 18, 2025
Multinational medical technology players are urging Indian regulators to reauthorize imports of refurbished medical devices—citing their crucial role in healthcare accessibility across tier-2 to tier-4 cities and rural regions. The Medical Technology Association of India (MTaI) has formally appealed for interim import approvals from both the Directorate General of Health Services (DGHS) and the Ministry of Environment, Forest and Climate Change (MoEFCC).
In recent months, India halted the import of refurbished medical equipment, following directives that such devices lack clear regulatory provisions under the Medical Devices Rules of 2017. The Central Drugs Standard Control Organisation (CDSCO) instructed Customs to reject imports in the absence of specific licensing for these pre-owned devices.
MTaI chairman Pavan Choudary warns that this suspension is putting healthcare delivery—and associated employment—at risk in India's underserved areas. The association underscores that refurbished devices currently represent nearly 10 percent of the country's medical device industry, translating to a market size of approximately ₹1,500 crore .
Additionally, MTaI advocates for the integration of medical devices into the government's Electronics Repair Services Outsourcing (ERSO) pilot program. Launched in May 2023 by the Ministry of Electronics and IT (MeitY), the ERSO initiative aims to develop India as a global repair hub. Including medical devices in this framework could drive technology transfer and enable advanced component recovery systems .
The MoEFCC had earlier, via a 2023 amendment to its Hazardous and Other Wastes (Management & Transboundary Movement) rules, permitted the import of refurbished medical devices to aid e-waste management. However, this was countermanded this year by the CDSCO’s directive, citing the absence of regulatory infrastructure for such imports .