The Government of India has formed a committee under the Ministry of Health and Family Welfare to develop a regulatory policy for refurbished medical devices, in a move aimed at clarifying their scope and establishing uniform safety and performance standards.
The committee will review methods for evaluating refurbished equipment, including criteria related to safety, functional performance and remaining useful life. It will also propose guidelines for the safe disposal of such devices.
Current regulations governing medical devices in India fall under the Drugs and Cosmetics Act, 1940 and the Medical Devices Rules, 2017. The new panel’s work is intended to address a regulatory gap in how refurbished devices are treated under these frameworks.
The decision to establish the panel follows regulatory conflicts within the medical device sector. Late last year, an expert committee under the Ministry of Environment, Forest and Climate Change cleared consignments of high-end refurbished equipment, despite existing restrictions on the import of such devices under national health rules.
Regulators have previously reiterated that refurbished medical devices cannot be imported for sale or distribution because the current Medical Devices Rules do not provide specific provisions for such imports.
Domestic manufacturers have raised concerns about the potential influx of near end-of-life equipment and industry stakeholders continue to call for a clear, harmonised policy framework.
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