AiMeD Warns Against Refurbished Medical Device Imports Without Global-Grade Safety Rules
New Delhi: The Association of Indian Medical Device Industry (AiMeD) strongly opposes 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 the International Medical Device Regulators Forum (IMDRF).
"Patient safety, clinical outcomes, and public trust remain non-negotiable. Refurbished devices pose risks from unknown histories, inconsistent performance, limited traceability, and shortened lifespans—issues unverifiable through post-facto checks alone. Just as Prime Minister Narendra Modi rejected imports of pre-owned Apple iPhones, urging Apple and Foxconn to establish manufacturing plants in India—much like for car manufacturers—healthcare demands even stricter vigilance, where lives hang in the balance. Countries like Indonesia, Thailand, Vietnam, China, Egypt, Brazil, Jordan, and Peru totally disallow such imports to safeguard public health. India must prioritize 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." Said Rajiv Nath, Forum Coordinator, AiMeD .
For Indian equipment, beyond extended warranties and Annual Maintenance Contracts (AMCs), the Association of Indian Medical Device Industry (AiMeD) has called for amendments to the Medical Device Rules (MDR) to treat remanufactured or refurbished medical devices as distinct, uniquely identifiable and fully traceable batches, released into the market only after individual calibration, performance testing, validation, and recall-ready mechanisms, comparable to the regulatory standards applied to new medical device batches.
PLI scheme beneficiaries echo this amid CDSCO regulatory enforcement review confusion and ongoing unchecked open resale in large volumes.
“Consistent policy support, not import liberalization, will scale our Cathlab imaging innovations,” says Gaurav Aggarwal, MD, Involution Technologies.
“Robotic surgery is a precision-driven discipline where safety, reliability, and traceability are non-negotiable. 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, not open doors to uncertain, end-of-life technology.”reaffirmed , Dr. Srivastav, CMD, SS Innovations.
It’s a fallacy that consumers gain from affordable access to preowned equipment. Does any clinic display the life of equipment? The last calibration date? The discounted rate of utility of decade-old equipment like a preowned dialysis machine or a CT or MRI versus a new one in same facility ? “ added Mr. Nath.
“BPL’s growth under PLI demands rejection of these imports,” asserted Mr. Sunil Khurana.
AiMeD urges the government to uphold the ban, enforce CDSCO oversight, and bolster local innovation for a safe healthcare future.
Furthermore, AiMeD noted that the total import of medical devices last year was 76000 Cr Rs, of which 48000 Cr Rs was medical electronics; and AiMeD estimates 12-15000 Cr of unauthorized trade of preowned medical equipment without any regulatory oversight is ongoing—just google India Mart and be flooded with offers.
Further it added, "This is highly unsafe for patients if no calibration being done and legalising it means good-bye to any Make in India efforts, and for the next pandemic we will again be scurrying for Indian-made ventilators, oxygen concentrators, etc."
