AiMeD Opposes Any Easing of Curbs on Refurbished Medical Device Imports
New Delhi, 9 February 2026: The Association of Indian Medical Device Industry (AiMeD) has voiced strong opposition to any move to reconsider or dilute policy restrictions on the import of refurbished or pre-owned medical equipment, warning that such steps without a stringent regulatory framework could compromise patient safety.
AiMeD said any policy shift should be tied to a robust and enforceable system aligned with global benchmarks such as those of the International Medical Device Regulators Forum (IMDRF). According to the industry body, refurbished devices often come with “unknown usage histories, inconsistent performance, limited traceability, and shortened life cycles,” risks that cannot be fully mitigated through post-facto checks.
Rajiv Nath, Forum Coordinator at AiMeD, said patient safety, clinical outcomes and public trust must remain paramount. He argued that healthcare requires even tighter safeguards than other sectors, drawing a parallel with the government’s push for domestic manufacturing in electronics and automobiles. Nath added that several countries — including Indonesia, Thailand, Vietnam, China, Egypt, Brazil, Jordan and Peru — do not allow such imports in order to protect public health.
AiMeD urged policymakers to prioritise new, domestically manufactured devices under initiatives such as Make in India, Atmanirbhar Bharat and the Medical Devices Policy, rather than permitting what it described as end-of-life equipment entering the country. For Indian-made equipment, the association also called for amendments to the Medical Devices Rules (MDR) to treat remanufactured or refurbished products as distinct, traceable batches, released only after individual calibration, testing and recall provisions similar to those applied to new devices.
Manufacturers benefiting from the Production Linked Incentive (PLI) scheme echoed the concerns. Gaurav Agarwal, Managing Director of Involution Technologies, said consistent policy support was essential to scale domestic innovations, including Cathlab imaging systems, and cautioned against import liberalisation amid ongoing regulatory enforcement reviews.
Dr. Sudhir Srivastava, CMD of SS Innovations, said high-precision segments such as robotic surgery demand strict standards of safety, reliability and traceability. Allowing refurbished equipment without a globally benchmarked framework, he said, could introduce unacceptable clinical risks and undermine indigenous innovation.
Nath also questioned claims that pre-owned equipment improves affordability for patients. He said transparency on equipment age, calibration history and performance is often lacking, and argued that older systems such as dialysis machines, CT scanners and MRI units may deliver reduced utility compared with new machines used in the same facilities.
Citing trade data, AiMeD said India’s total medical device imports last year were about ₹76,000 crore, of which ₹48,000 crore was medical electronics. The association estimated that ₹12,000–15,000 crore worth of pre-owned medical equipment is being traded without regulatory oversight. It warned that legalising such imports without safeguards could weaken domestic manufacturing capacity and leave the country vulnerable during future health emergencies.
