The Association of Indian Medical Device Industry (AiMeD) has firmly opposed any move to reconsider or relax policy restrictions on the import of refurbished or pre-owned medical equipment in India. The industry body warns that allowing such imports without a strict, enforceable regulatory framework aligned with global standards like IMDRF could seriously compromise patient safety and public trust.
Patient Safety Cannot Be Compromised
AiMeD emphasized that patient safety, clinical outcomes, and trust in healthcare systems are non-negotiable. Refurbished medical devices often come with unknown usage histories, inconsistent performance, limited traceability, and
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reduced operational life. These risks, according to the association, cannot be reliably addressed through post-import inspections alone.
Rajiv Nath, Forum Coordinator at AiMeD, stated that healthcare equipment requires far stricter scrutiny than consumer electronics. He drew a parallel to the Prime Minister’s rejection of pre-owned iPhone imports and the push for local manufacturing, noting that when human lives are involved, the standards must be even higher.
Global Precedents Support Import Restrictions
AiMeD highlighted that several countries including Indonesia, Thailand, Vietnam, China, Egypt, Brazil, Jordan, and Peru completely prohibit the import of refurbished medical equipment. These nations have adopted strict policies to safeguard public health and avoid becoming dumping grounds for end-of-life medical technology.
The association urged India to follow similar global best practices and focus on promoting new, high-quality, indigenously manufactured medical devices.
Push for Make in India and Atmanirbhar Bharat
According to AiMeD, relaxing import norms would directly undermine national initiatives such as Make in India, Atmanirbhar Bharat, and the Medical Devices Policy. The organization stressed that India should strengthen domestic manufacturing rather than depend on outdated, pre-owned equipment from overseas markets.
Call for Stronger Regulations on Refurbishing in India
For refurbished or remanufactured medical equipment within India, AiMeD called for amendments to the Medical Device Rules (MDR). The association proposed treating refurbished devices as unique, traceable batches that are released only after individual calibration, testing, and clear recall mechanisms, similar to requirements for new medical devices.
Industry Voices Raise Concerns
Industry leaders echoed AiMeD’s concerns, especially in light of ongoing confusion around CDSCO enforcement and the unchecked resale of used equipment.
Gaurav Aggarwal, Managing Director of Involution Technologies, stated that consistent policy support is essential to scale India’s cathlab imaging and medical technology innovations, not import liberalization.
Dr Srivastav, CMD of SS Innovations, warned that in precision-driven fields like robotic surgery, safety, reliability, and traceability are critical. Allowing refurbished equipment without global-level regulation introduces unacceptable clinical risks.
Sunil Khurana, Executive Chairman of BPL Medical, asserted that the success of PLI-backed companies depends on rejecting refurbished imports and supporting domestic growth.
Questioning the Affordability Argument
AiMeD also challenged the claim that refurbished equipment improves affordability for patients. Rajiv Nath questioned whether clinics disclose critical details such as equipment lifespan, last calibration dates, or the reduced utility of decade-old machines like dialysis units, CT scanners, or MRI systems when compared to new equipment used in the same facility.
AiMeD Urges Government to Maintain the Ban
AiMeD has urged the Government of India to maintain the ban on refurbished medical equipment imports, strengthen CDSCO oversight, and continue supporting local innovation. The association believes that prioritizing quality, safety, and indigenous manufacturing is essential to building a secure and trustworthy healthcare system for the future.
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Operon Strategist is a global regulatory and consulting partner supporting pharmaceutical and medical device companies across the entire product lifecycle. We provide end-to-end services including FDA 510(k) and PMA support, CE marking and UKCA approvals, ISO 13485 certification, MDSAP consulting, CDSCO and global market registrations, QMS implementation, design control documentation, cleanroom validation, manufacturing setup guidance, and regulatory strategy consulting. With strong expertise across India, the EU, the UK, and the USA, Operon Strategist helps startups, MSMEs, and established manufacturers achieve faster approvals, maintain compliance, and scale confidently in global healthcare markets.
