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. According to reports from Business Standard, the Centre constituted an interministerial committee to frame guidelines for the import of refurbished medical devices, but the proposed framework remains under discussion with no comprehensive guidelines notified so far. The committee has held only a few meetings and has begun examining data on the refurbished equipment market, including 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 representatives.
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. As reported by Business Standard, 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. However, 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 must 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.
The regulatory gap is not new, as reported by Business Standard. 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. Currently, 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, including CT scanners, MRI systems, ultrasound and X-ray equipment. These equipment must 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 industry itself is divided over how far India should open the door to refurbished equipment, according to Business Standard reports. Rajiv Nath, forum coordinator of the Association of Indian Medical Device Industry (AiMeD), noted there is no separate import classification for refurbished medical devices, making it difficult to determine their exact share in India's medical device imports. Multinational medical technology manufacturers support allowing refurbished equipment but want imports to come through original equipment manufacturers or their authorised channels. An 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.
Nearly a year into the exercise, 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, as reported by Business Standard. A senior MoHFW official indicated that 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. The MoEFCC is understood to have received a draft or proposal from the health ministry for comments, though it has not been directly involved in framing the policy.
