Refurbished Medical Device Imports Threaten Patient Safety, Indigenous Manufacturing, Warns Industry
New Delhi: As India pushes to strengthen its domestic medical device ecosystem, industry stakeholders have cautioned that the import of refurbished and pre-owned medical devices poses serious risks to patient safety, regulatory clarity and indigenous innovation, warning that such equipment may be outdated, poorly supported and inconsistent with existing medical device regulations.
Industry representatives have flagged that approvals for refurbished medical equipment contradict the current regulatory position of the Central Drugs Standard Control Organisation (CDSCO), which has clarified that refurbished medical devices are not permitted for import under the Medical Devices Rules, as no licence is issued for their sale or distribution. Stakeholders fear that this regulatory inconsistency could compromise healthcare delivery and weaken confidence in India’s oversight framework.
Manufacturers and experts pointed out that refurbished devices often involve older technology, uncertain maintenance histories and limited after-sales support, increasing the risk of inaccurate diagnostics, treatment errors and equipment failures. Concerns were raised that high-end equipment such as CT scanners, MRI systems and other advanced diagnostic devices entering the country in refurbished form could adversely affect patient outcomes.
The industry has also warned that allowing refurbished imports could stifle domestic manufacturing, discourage investment in research and development, and slow innovation in the medical device sector. Such imports, they argue, undermine the objectives of the government’s Make in India and Atmanirbhar Bharat initiatives, while creating unfair competition for Indian manufacturers producing compliant, new-generation equipment.
According to a recent media report in the Economic Times, industry bodies have urged the Ministry of Environment, Forest and Climate Change (MoEFCC) and other authorities to withdraw approvals granted for refurbished medical device imports, align policy decisions with CDSCO regulations, and ensure strict enforcement to safeguard patient safety and promote sustainable growth of the domestic medical device industry.
Stakeholders reiterated that a clear, consistent and safety-first regulatory approach is essential to prevent India from becoming a dumping ground for obsolete medical technology and to ensure long-term innovation in healthcare manufacturing.
