India Divided Over Used Medical Equipment Imports

India's medical device industry is split over the importation of refurbished medical equipment. Concerns about safety, oversight, and the impact on domestic manufacturing are prominent among Indian producers. Conversely, international medical device associations are pushing for a clear regulatory policy under the Ministry of Health and Family Welfare, rather than restrictions or bans.

A government committee has been formed to examine the scope of refurbished devices, develop safety evaluation methodologies, and suggest waste disposal guidance. Refurbished equipment includes used MRI scanners, CT machines, and robotic surgery systems, offered at significantly lower costs than new ones, making advanced diagnostics more accessible in Tier-2 and Tier-3 cities.

Currently, India lacks a dedicated regulatory pathway for refurbished devices under the Medical Devices Rules, 2017. Imports are governed by environmental and waste management rules, creating a regulatory clash with health authorities. This ambiguity over classification and compliance is a key issue.

Stakeholders are debating industrial policy versus healthcare access. While some fear unrestricted imports could harm domestic manufacturing, others emphasize the role of refurbished equipment in expanding diagnostic reach. International manufacturers advocate for policies allowing refurbished devices through original equipment manufacturers, ensuring accountability and service. Domestic manufacturers, however, argue against relaxing restrictions without a robust framework, citing risks from unknown histories and inconsistent performance, and suggest prioritizing new, indigenously manufactured devices.