Domestic medical device manufacturers have opposed the government’s move to form a panel to reconsider or relax policy restrictions on importing refurbished or pre-owned medical equipment in the country.
The top body for medical devices, Association of Indian Medical Device Industry (AiMeD), has said that refurbished devices pose risks from unknown histories, inconsistent performance, limited traceability, and shortened lifespans.
“Patient safety, clinical outcomes, and public trust remain non-negotiable for us. Pre-owned medical equipment, especially without a robust, enforceable regulatory framework benchmarked to global standards can harm the end consumers.
It’s a fallacy that consumers gain from affordable access by pre-owned equipment,” said Rajiv Nath, forum coordinator at AiMeD.
What did Anupriya Patel say?
Last week, the minister of state for chemicals and fertilisers Anupriya Patel told the parliament that government has constituted a panel to examine the scope of refurbished medical devices, methodology to evaluate the safety, performance, and remaining useful life of refurbished medical devices.
The central drugs regulator had banned the import of used medical devices in January 2025 until a policy framework is established.
The association said that countries such as Indonesia, Thailand, Vietnam, China, Egypt, and Brazil disallow such imports to safeguard public health. “India must prioritise new, indigenously manufactured devices under ‘Make in India’, and the medical devices policy, rather than becoming a dumping ground for old equipment,” Nath said.
What did Sudhir Srivastava say?
“Robotic surgery is a precision-driven discipline where safety, reliability, and traceability are non-crucial. Allowing refurbished or pre-owned medical equipment without a globally benchmarked regulatory framework introduces unacceptable clinical risk. India must strengthen indigenous innovation under ‘Make in India’ instead of opening doors to uncertain, end-of-life technology.” said Sudhir Srivastava, chairman and CEO of SS Innovations.
AiMeD has said that even India-made equipment which are beyond extended warranties should be allowed for use only after individual calibration, testing, and recall mechanisms – similar to new equipment batches.
Despite growing exports, India remains heavily import-dependent for medical equipment with $8.4 billion in imports in FY25, representing over 80% of the overall market size. It’s estimated that Rs 12,000-15,000 crore of unauthorised trade of pre-owned medical equipment is taking place annually without any regulatory oversight.
Meanwhile, the association of MedTech importers have welcomed the government’s move. “As India actively pursues free trade agreements (FTAs), we urge the adoption of a time-bound, globally aligned policy. Such a framework should permit the use of refurbished devices only when managed through original equipment manufacturers (OEMs), ensuring clear legal accountability, robust service support, and stringent patient safeguards,” said Pavan Choudary, chairman of Medical Technology Association of India (MTaI).