Many industry experts welcome the move, while others, emphasise the need for an expedited policy framework to minimise disruption
The Indian government has suspended all imports of refurbished medical devices until the Ministry of Health and Family Welfare (MoHFW) establishes a policy framework. This move affects the pre-owned medical equipment market, which constitutes approximately 10 per cent of India’s total medical equipment industry.
Pavan Choudary, Chairman of the Medical Technology Association of India (MTaI), highlighted the significance of refurbished devices in tier 2, 3, and 4 cities, as well as rural and underserved areas. According to him, “If a swiftly implementable policy is not introduced soon, it could lead to irreversible damage to both healthcare providers and the workforce.”
These regions rely on affordable solutions such as pre-owned equipment to meet healthcare demands, with 70 per cent of facilities being privately run, including small clinics, nursing homes, standalone hospitals, and diagnostic centres.
Globally, the pre-owned medical device market has been integrated into healthcare systems. Developed regions like the United States and the European Union rely on refurbished devices for 7–9 per cent of their needs. Countries such as the US, UK, Canada, Japan, South Korea, New Zealand, and Australia regulate the import and sale of these devices to ensure healthcare accessibility.
The suspension has halted imports, creating uncertainties for healthcare providers and impacting the sector’s workforce. MTaI has urged the expert committee to accelerate the formation of a policy framework. Choudary suggested interim measures, such as allowing imports with necessary approvals from the Directorate General of Health Services (DGHS) and the Ministry of Environment, Forest and Climate Change (MoEFCC), to prevent further disruption.
On the other hand, Rajiv Nath, Forum Coordinator of the Association of Indian Medical Device Industry (AiMeD), welcomed the clarification. He stated, “While one ministry and its regulations may permit imports of pre-owned medical devices with respect to e-waste management concerns, other regulators like AERB or CDSCO have to play their own role. Until there is an unequivocal policy decision by MoHFW permitting imports of pre-owned equipment and amendments to MDR to suitably address high-risk patient safety concerns, it is not permissible to import pre-owned medical equipment.” Nath further emphasised the alignment of the policy with the National Medical Devices Policy 2023, which aims to position India as a leading manufacturing hub.
Dr Jitendra Sharma, Managing Director of AMTZ, Vishakapatnam, supported the intervention, stating, “A stop to import of refurbished medical equipment is a true policy intervention that will guard the domestic industry against dumping of equipment with uncertain quality, and will also help the patients in receiving appropriate medical care thereby bringing the best value of cost for them and for the payers, including insurance agencies.”
Prof Bejon Kumar Misra, Founder of the Patient Safety and Access Initiative of India Foundation, also expressed approval of the decision. He stated, “The circular issued by CDSCO on 10th January regarding refurbished medical devices imported into India has shown Modi 3.0 is awake and ready to listen to a common consumer. Now our next logical step should be to recall all such illegally imported medical devices from every corner of the country and destroyed in the interest of ‘Patient Safety.’”
Siddhartha Bhattacharya, Secretary General of NATHEALTH, stressed the importance of a balanced approach. “Refurbished products can be regulated to ensure safety and efficacy, and it should not be seen purely from a manufacturing lens, which may limit consumer choice. Markets and consumers determine products, and it’s not the other way around. It is about ensuring that proper guardrails for safety and efficacy are in place to ensure no dumping, benefiting both domestic and global manufacturers. Many countries around the world have established policies that support a refurbishment market, enabling medical devices to penetrate segments of society where access, affordability, and equity are significant issues.
For India, NATHEALTH strongly suggests that a well-considered policy and guidelines with cross value chain feedback linking to patients be swiftly implemented to facilitate the creation of a well-regulated refurbished Medtech market for appropriate beneficiaries and product segments.”
MTaI reiterated the importance of collaborative action to safeguard the healthcare system and the refurbished medical device sector, stressing that an expedited policy framework is essential to mitigate the impact of this decision.
