Medtech manufacturing industry divided on policy for refurbished devices

Domestic device makers warn of safety and dumping risks, while MNC bodies back affordability benefits as the Centre reviews policy on refurbished high-end medical device imports

The Centre’s plan to form a new import policy for refurbished high-end medical devices has divided the medtech manufacturing industry. This comes even as imports continue despite a lack of regulation for the devices.

 

The multinational company (MNC) representative bodies have welcomed the policy review as a means to expand affordable healthcare, while domestic manufacturers say the step could risk patient safety and provide a threat to local manufacturers.

 

Domestic device makers body Association of Indian Medical Device Industry (AiMeD) on Monday said that they are against any move to reconsider or relax policy curbs on importing refurbished or pre-owned medical equipment, especially without an enforceable regulatory framework benchmarked to global standards. 

 

“Countries like Indonesia, Thailand, China 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 (MDR), rather than becoming a dumping ground for end-of-life equipment,” Rajiv Nath, forum coordinator, AiMeD added.

  However, multinational industry bodies contend that regulated refurbishing of medical equipment can significantly improve patient access, promote healthcare worker training, facilitate component harvesting and ecosystem development and reduce grey market risks. 

 

“Healthcare facilities in Tier-II and Tier-III cities often lack the financial capacity to invest in high-capex equipment. Refurbished devices, available at significantly lower cost, can help bridge this gap,” said Pavan Choudary, chairman, Medical Technology Association of India (MTaI).

 

Valued at around ₹1,500 crore, the pre-owned medical equipment market currently constitutes around 10 per cent of the total medical equipment industry in India. 

 

However, AiMeD representatives claimed that, while India’s total medical devices was estimated at around ₹76,000 crore in 2025, the industry sees an unauthorised trade worth ₹12,0000-15,000 crore of pre-owned medical equipment without any regulatory oversight.

 

Globally, regulated markets such as the US and EU permit the use of refurbished medical devices, which account for approximately 7 to 9 per cent of total medical equipment volumes.

 

Choudary said that as India actively pursues free-trade agreements (FTAs) and Bilateral Trade Agreements (BTAs), it is important to adopt a time-bound, globally aligned policy. 

 

“Such a framework should permit the use of refurbished devices only when managed through original equipment manufacturers (OEMs), ensuring clear legal accountability, robust service support, and stringent patient safeguards, till the time the local product reaches equivalence,” he added.

 

The Centre’s move for a policy review comes after central regulator CDSCO, in a letter to the Principal Commissioner of Customs last year, clarified that refurbished medical devices cannot be imported into the country for sale and distribution, as there is no specific regulation for such devices under the Medical Devices Rules, 2017. 

 

However, import of refurbished devices are still allowed through no-objection certificates from an expert committee of the Ministry of Environment, Forest and Climate Change (MoEFCC), which can approve applications to bring in 38 high-end and high-value (HEHV) medical equipment strictly based on a list prescribed by the DGHS.

 

Choudary added that any policy must include medical devices under the government’s Electronics Repair Service Outsourcing (ERSO) scheme. “This ensures devices are updated by experts with genuine spares that meet strict regulatory guidelines,” he said.

 

In 2024, a patient advocacy group, the Patient Safety and Access Initiative of India Foundation (PSAIIF) had filed a public interest litigation in the Delhi High Court, raising concerns over the large-scale illegal import of HEHV used medical equipment other than critical care.

 

The PIL was later rejected, noting that there are no provisions under the existing regulations.