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.
The government informed the House that medical devices in India are governed by statutory provisions under the Drugs and Cosmetics Act and the Medical Device Rules notified in 2017. To strengthen oversight specifically over refurbished medical devices, the Ministry of Health and Family Welfare has constituted a committee on the “Policy on regulation of refurbished medical devices.”
The committee has been tasked with examining the scope of refurbished medical devices, developing a methodology to evaluate safety, performance and remaining useful life, and suggesting guidelines for waste disposal of refurbished equipment once their lifecycle ends. This move aims to ensure that refurbished devices used in healthcare settings meet safety and quality standards and do not pose risks to patients.
The government indicated that it is currently focusing on strengthening regulatory safeguards rather than recalling the existing policy, and is working towards a structured framework that balances access to medical technology with patient health and safety concerns.
