Medical device makers urge Centre to reconsider approvals for refurbished imports

Indian manufacturers of medical devices have written to the Central government urging it to urgently reconsider approval grants for the import of refurbished and reconditioned medical devices, stating that the move raises concerns for India’s healthcare ecosystem, which has invested years in indigenous research, engineering and manufacturing to build world-class technologies under the “Make in India” vision.

“Despite the Central Drugs Standard Control Organisation’s clear ban on the import of refurbished medical equipment, and with the matter currently sub judice before the courts, such approvals risk undermining regulatory integrity and creating an uneven playing field for domestic innovators,” stakeholders said in a statement.

They added that the practice weakens the domestic medical device industry and undermines the work of innovators.

“While Indian manufacturers create cutting-edge, globally competitive devices, the entry of old, depreciated foreign machines threatens to flood the market with technology that has already lived its commercial life elsewhere. India cannot afford to become a dumping ground for medical electronic waste under the guise of refurbished equipment,” Rajiv Nath, forum coordinator, Association of Indian Manufacturers of Medical Devices (AiMeD), said.

In their statement, the group of manufacturers said regulatory contradiction in the matter was also a cause for concern.

Both India’s medical device industry and patient safety advocates have raised objections to the recent decision of the Ministry of Environment, Forest and Climate Change to permit the import of refurbished and reconditioned medical devices, including robotic surgical systems, MRI machines, CT scanners and other high-value equipment.

Srinivasa Reddy, senior vice-president, SS Innovations, said allowing refurbished medical devices into India at this stage sent the wrong message to manufacturers who had invested years in building world-class technologies domestically.

“Also when the CDSCO has clearly stated that refurbished devices cannot be imported, parallel permissions only create confusion and unfair advantage,” he said.

Stakeholders pointed out that the Patient Safety and Access Initiative of India Foundation has filed a writ petition before the Delhi High Court seeking a ban on refurbished imports, warning that India risks becoming a dumping ground for used medical equipment. Notices have been issued to multiple ministries and the matter remains sub judice.

Mr. Viswanathan Santhanagopalan, Managing Director, Sequoia Healthcare, said government tendering frequently disadvantaged Indian high-end and high-value medical equipment manufacturers, such as those producing CT scanners, MRI machines and robotic assistance systems, by demanding unnecessary advanced features and foreign certifications instead of relying on Indian standards such as the Bureau of Indian Standards.

“Identical import duties on new and used medical equipment allow refurbished global systems to compete directly with high-value Indian devices, suppressing domestic demand and discouraging local innovation and scale-up. The absence of a comprehensive safety and regulatory framework for used equipment sales and third-party service providers creates patient safety risks and enables an unregulated market that erodes the competitiveness of compliant Indian manufacturers,” he said.

“Imported machines often carry outdated technology, unpredictable performance and unreliable spare-part support, resulting in frequent breakdowns and compromised diagnostic accuracy. Many refurbished systems do not meet the latest global safety standards, and their shorter lifespan and hidden defects create avoidable risks during critical medical procedures. At a time when India is rapidly advancing its healthcare capabilities, we must avoid lowering the technological benchmark by depending on obsolete imports. Instead, our focus should be on adopting modern, efficient and locally manufactured equipment that ensures long-term reliability, better clinical outcomes and supports the growth of India’s medical technology ecosystem,” R.S. Kanwar, Director, Overseas Operations, Allengers Medical Systems Ltd., said.