Indian medical device makers worried about policy on refurbished medical equipment imports

Domestic medical device makers have sounded alarm over the decision of the Ministry of Health and Family Welfare to review the rules pertaining to the regulation of refurbished medical devices.

The Association of Indian Medical Device Industry (AiMeD) said it 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 IMDRF (International Medical Device Regulators Forum).

AiMeD reacts to panel on refurbished medical device policy

AiMeD comments have come in the backdrop of the constitution of a committee by the ministry on ‘policy on regulation of refurbished medical devices’, to examine the scope of refurbished medical devices, methodology to evaluate the safety, performance, and remaining useful life of refurbished medical devices and suggest guidance for waste disposal of such refurbished devices.

“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," Rajiv Nath, Forum Coordinator, AiMeD, said.

Industry flags global curbs on refurbished device imports

Nath points out that Indonesia, Thailand, Vietnam, China, Egypt, Brazil, Jordan, and Peru totally disallow such imports to safeguard public health. “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”, he adds.

AiMeD wants India to amend existing rules to treat remanufacturing/refurbishing as unique, traceable batches—released only after individual calibration, testing, and recall mechanisms, akin to new medical equipment batches.

 “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”, Dr. Srivastav, CMD, SS Innovations said.

Last year, Indian drug regulator Central Drugs Standard Control Organisation (CDSCO) had suspended the import of refurbished medical devices until a comprehensive policy framework to regulate its quality is in place. While the constitution of the committee is in line with the government’s policy to ready a comprehensive policy, industry is worried of low or zero duty imports of refurbished high value medical devices from developed markets like the US, with which India has announced bilateral trade agreements.