Medtech industry divided over Centre’s review of refurbished device imports | Industry News

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

Responding to a query in the Rajya Sabha last week, Minister of State for Health Anupriya Patel said the ministry has constituted a committee on policy for the regulation of refurbished medical devices. The committee will examine the scope of refurbished medical devices, the methodology to evaluate the safety, performance and remaining useful life of such devices, and suggest guidance for their waste disposal.

Domestic manufacturers’ body Association of Indian Medical Device Industry (AiMeD) on Monday said it is opposed to any move to reconsider or relax policy restrictions on importing refurbished or pre-owned medical equipment, especially without an enforceable regulatory framework benchmarked to global standards.

“Countries like Indonesia, Thailand and China totally disallow such imports to safeguard public health, and 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,” said Rajiv Nath, forum coordinator at AiMeD.

“Healthcare facilities in tier-2 and tier-3 cities often lack the financial capacity to invest in high-capex equipment upfront. Refurbished devices, available at significantly lower cost than new equipment, can help bridge this gap,” said Pavan Choudary, Chairman of the 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 market was estimated at around ₹76,000 crore in 2025, the industry sees unauthorised trade worth ₹12,000–15,000 crore in pre-owned medical equipment without any regulatory oversight.

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

“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 to review policy follows a clarification issued last year by the Central Drugs Standard Control Organisation (CDSCO) to the principal commissioner of customs 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, imports 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 Directorate General of Health Services (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 devices.

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