New Delhi: The Union Health Ministry’s plan to regulate the use of refurbished high-end medical devices, amid a blanket ban on their imports, has drawn strong opposition from the domestic MedTech firms in India.
Responding to a query in the Rajya Sabha last week, Anupriya Patel, Minister of State, Ministry of Health and Family Welfare, shared that the ministry has constituted a committee on ‘Policy on regulation of refurbished medical devices’.
The committee will examine “the scope of refurbished medical devices, methodology to evaluate the safety, performance, and remaining useful life of refurbished medical devices & suggest guidance for waste disposal of such refurbished devices.”
However, citing risk to patient safety and threat to local manufacturers, the Association of Indian Medical Device Industry (AiMeD) in a statement said, “We strongly oppose any move to reconsider or relax policy restrictions on importing refurbished or pre-owned medical equipment, especially without a robust, enforceable regulatory framework benchmarked to global standards like IMDRF.”
“We urge the government to uphold the ban, enforce CDSCO oversight, and bolster local innovation for a safe healthcare future,” the body added.
Speaking for domestic firms, Rajiv Nath, Forum Coordinator, AiMeD said, “Countries like Indonesia, Thailand, China, totally disallow such imports to safeguard public health and India must prioritise new, indigenously manufactured devices under Make in India, Atmanirbhar Bharat, and the Medical Devices Policy, rather than becoming a dumping ground for end-of-life equipment.”
With high end devices such as surgical robots, Dr Sudhir Srivastav, CEO and Chairman, SS Innovations, added, “such devices are used in procedures that require precision-driven discipline, and permitting refurbished or pre-owned medical equipment without a globally benchmarked regulatory framework introduces unacceptable clinical risk.”
Meanwhile, Pavan Choudary, Chairman, Medical Technology Association of India (MTaI), a MNC representative, said, “The government’s decision to set up a committee to frame a policy on refurbished medical devices can position India as a premier electronics repair hub for the Global South.”
“It will facilitate advanced training for healthcare workers in Tier-2 and Tier-3 cities and strengthen the Electronics Repair Services Outsourcing (ESRO) initiative,” he added.
The import of refurbished medical devices has long been a point of contention between local and multinational manufacturers.
International players contend that refurbishing equipment can reduce costs for hospitals and ultimately benefit patients, domestic forms however, stress that it could undermine their growth transition from high-volume to high-value segments.
Over potential cost benefits for patients, Nath said, “clinics rarely disclose the lifespan of their devices and the discounted utility of decade-old equipment—such as a pre-owned dialysis machine, CT scanner, or MRI—compared with a new device in the same facility is seldom transparent.”
In 2023, India allowed the import of refurbished medical devices after the Ministry of Environment, Forest and Climate Change (MoEFCC) framed it as a measure to support the country’s e-waste management efforts.
However, citing policy ambiguities, the central regulatory authority, CDSCO, later disallowed their import, informing the Director General of Customs that no provision currently permits such imports.
The market for refurbished medical devices in India is estimated to account for around 10 per cent of the total market and is largely concentrated in Tier-2 and Tier-3 cities.
AiMed representatives claim that, while India’s total medical devices is estimated at around Rs 76,000 crore (2025), the industry sees an “unauthorised trade of Rs 12-15000 crore worth preowned medical equipment without any regulatory oversight is ongoing.”
Notably, in 2024, a patient advocacy group, the Patient Safety and Access Initiative of India Foundation (PSAIIF) had filed a public interest litigation in the Delhi High Court, raising concerns over the large-scale illegal import of high-end and high-value used medical equipment other than critical care, (Refurbished HEHV medical equipment).
The PIL was later rejected, noting that there are no provisions under the existing regulations.
Globally, regulated markets such as the US and EU permit the use of refurbished medical devices, which account for approximately 7–9% of total medical equipment volumes.
Other developed states like Japan, UK, Australia etc. permit the import and sale of pre-owned medical equipment in accordance with their regulations.
