Imported Refurbished Medical Devices Under Regulatory Lens, Parliament Told
New Delhi: The Union Government has clarified that imported refurbished and used medical devices, including high-end and high-value equipment, are regulated under the existing Drugs and Cosmetics Act, 1940 and the Medical Device Rules, 2017, and that a dedicated expert committee has been constituted to frame a comprehensive policy to ensure patient safety and regulatory oversight.
Responding to a question in the Rajya Sabha, the Minister of State for Chemicals and Fertilizers Anupriya Patel stated that the regulation of refurbished medical devices falls under the jurisdiction of the Ministry of Health and Family Welfare. The reply addressed concerns regarding whether the import of high-end and high-value used medical equipment—other than used critical care medical equipment—poses risks to patient safety or violates the medical regulatory framework.
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