To address concerns surrounding refurbished and imported used medical equipment, the Ministry has constituted a dedicated committee to examine the scope and regulation of such devices. The committee has been tasked with studying global best practices and recommending a structured policy framework tailored to India’s healthcare ecosystem.
According to the government, the panel will evaluate key parameters such as safety standards, performance benchmarks and the remaining useful life of refurbished medical devices. These aspects are critical, especially for high-end diagnostic and therapeutic equipment used in tertiary and critical care settings.
Focus on Patient Safety and Lifecycle Assessment
The government’s response underlines that refurbished medical equipment must not compromise patient safety or clinical outcomes. The proposed framework will include a scientific methodology to assess device performance and functional reliability before such equipment is permitted for use in healthcare facilities.
Lifecycle assessment will also play a crucial role in the policy. By evaluating the remaining operational life of refurbished devices, regulators aim to ensure that only equipment with sufficient longevity and serviceability enters the Indian healthcare system.
Guidelines for Environmentally Safe Disposal
In addition to safety and performance, the committee has been asked to suggest clear guidance for the disposal of refurbished medical devices once they reach the end of their usable life. Improper disposal of electronic and biomedical equipment poses environmental and public health risks.
The proposed policy is expected to align with India’s broader commitments towards sustainable healthcare and responsible waste management, particularly in the context of biomedical and electronic waste regulations.
Balancing Access and Regulation
Refurbished high-end medical equipment has often been seen as a cost-effective option for hospitals, especially in smaller cities and resource-constrained regions. Such equipment can help expand access to advanced diagnostic and treatment facilities at relatively lower costs.
However, the government has acknowledged that the absence of a uniform regulatory framework can lead to inconsistencies in quality and safety. The proposed policy seeks to strike a balance between improving access to advanced medical technology and maintaining stringent regulatory oversight.
Statement in Rajya Sabha
The details were shared by Union Minister of State for Chemicals and Fertilizers, Smt. Anupriya Patel, in a written reply to a question in the Rajya Sabha on Tuesday. The response clarified the government’s intent to bring refurbished medical devices under a structured regulatory regime.
Officials believe that a clear policy will provide greater confidence to healthcare providers, patients and manufacturers, while also ensuring alignment with international regulatory norms.
Way Forward
Once finalised, the regulatory framework is expected to offer clarity to importers, hospitals and service providers dealing with refurbished medical devices. It may also pave the way for improved transparency and accountability in the medical technology sector.
The initiative marks another step in India’s efforts to strengthen healthcare infrastructure while safeguarding patient interests and promoting responsible use of medical technology.