Refurbished medical device import policy remains under discussion

India's proposed rules for refurbished medical device imports remain unresolved nearly a year after a government panel was formed, amid safety concerns and demand from smaller hospitals

Almost a year after the Centre constituted an interministerial committee to frame guidelines for the import of refurbished medical devices, the proposed framework remains under discussion, with no comprehensive guidelines notified so far.

 

At stake is a pre-owned medical equipment market estimated by industry executives at around ₹1,500 crore, or nearly 10 per cent of the overall medical equipment market. Hospitals and diagnostic centres, particularly in smaller cities, use such equipment to bring down the cost of installing expensive machines such as computed tomography (CT) and magnetic resonance imaging (MRI) scanners.

 

But domestic manufacturers worry that easier imports without adequate safeguards could expose patients to unsafe equipment and turn India into a market for obsolete machines. The government, therefore, has to decide what equipment can be imported, how old it can be, who certifies that it is safe and functional, and who is responsible if it fails.

 

People familiar with the matter told Business Standard that the committee set up to work out these rules has held only a few meetings and has begun examining data on the refurbished equipment market. It includes representatives from the Ministry of Health and Family Welfare (MoHFW), Directorate General of Health Services (DGHS), Central Drugs Standard Control Organisation (CDSCO), Department of Pharmaceuticals, and industry.

 

“The government constituted an interministerial committee to examine and frame guidelines for importing refurbished medical devices. However, no comprehensive guidelines specifically governing such imports have been notified so far,” said Rajiv Nath, forum coordinator of the Association of Indian Medical Device Industry (AiMeD). 

 

Queries mailed to the Union health ministry remained unanswered until the time of going to press.

 

The regulatory gap is not new. In a January 10, 2025, letter to the principal commissioner of Customs, the CDSCO acknowledged that the Medical Devices Rules (MDR), 2017, do not distinguish between new and refurbished medical devices.

 

That does not mean used medical equipment cannot enter India. An existing mechanism under the Ministry of Environment, Forest and Climate Change (MoEFCC) allows imports of 38 specified high-end and high-value equipment prescribed by the DGHS. These include CT scanners, MRI systems, ultrasound and X-ray equipment, besides some laboratory and critical-care devices.

 

There are conditions: the equipment should not have been phased out in the exporting country, should not contain hazardous material, and should have a residual life of at least seven years. The health ministry is now examining whether these rules are enough or whether refurbished medical devices need a more specific regulatory framework.

 

“Major issues to be discussed by the committee include determining the service time of secondhand devices eligible for import or allowing only very expensive, high-end critical-care equipment used for critical care,” a senior MoHFW official said.

 

The MoEFCC is understood to have received a draft or proposal from the health ministry for comments, although it has not been directly involved in framing the policy. “While the health ministry is amending provisions in the MDR, we have not been directly involved in policy formulation. However, MoHFW has shared a draft or proposal with MoEFCC for comments,” a person familiar with the matter said.

 

The industry itself is divided over how far India should open the door to refurbished equipment.

 

Nath said there is no separate import classification for refurbished medical devices, making it difficult to determine their exact share in India’s medical device imports. “Any such framework should prescribe requirements for quality, safety, performance, traceability, remaining useful life, servicing, and accountability of the importer and supplier,” he added.

 

Multinational medical technology manufacturers support allowing refurbished equipment but want imports to come through original equipment manufacturers or their authorised channels.

 

A multinational industry body told Business Standard that advanced CT scanners, MRI systems, and robotic surgical systems remain financially out of reach for smaller hospitals and institutions in Tier-II and Tier-III cities. Refurbished equipment, it argued, could make such technology more accessible without compromising safety. “We have proposed mandatory traceability, validated performance, maintenance and after-sales support, alongside legal accountability for importers and suppliers,” the industry body added.

 

Nearly a year into the exercise, however, the central question remains unresolved: whether India will broadly allow refurbished medical devices with safety safeguards or restrict imports to a smaller set of expensive, high-end equipment.