What is the current regulatory status of refurbished medical devices in India?

India currently lacks a dedicated regulatory pathway for refurbished medical devices under the Medical Devices Rules, 2017, leading to a complex and debated import process.

What are the main arguments for and against importing refurbished medical equipment in India?

Proponents highlight increased accessibility to advanced diagnostics at lower costs, especially in smaller cities, while opponents raise concerns about patient safety, inconsistent performance, and potential harm to domestic manufacturing.

What steps is the Indian government taking regarding refurbished medical devices?

The Ministry of Health and Family Welfare has formed a committee to examine the scope, safety, and regulation of refurbished medical devices, aiming to develop a clearer policy.

Home / Health / India Divided Over Used Medical Equipment Imports

India Divided Over Used Medical Equipment Imports

13 Feb

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Summary

India lacks a clear regulatory pathway for refurbished medical devices.
Domestic manufacturers fear safety risks and market impact.
International firms advocate for robust regulation over bans.

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.