In a move aimed at curtailing the influx of unregulated second-hand medical devices in the country, the apex drug regulator Central Drugs Standard Control Organisation (CDSCO) has informed the Customs Department that import of refurbished devices is not allowed. In a letter to the Principal Commissioner of Customs, the CDSCO said that all medical devices are regulated under the Medical Devices Rules, 2017.
"However, there is no specific provision for regulation of refurbished medical devices under the said rules. Hence, no licence is issued for import of such devices and it cannot be imported under Medical Devices Rules for sale and distribution," the CDSCO said.
Manufacturers of medical devices have welcomed the move, stating this decisive clarification reinforces the regulatory framework designed to ensure the highest standards of patient safety.
Dr Sudhir Srivastava, former Chair of the Medical Device Committee at PHDCCI, said that the decision by CDSCO marks a pivotal step towards reinforcing India's self-reliance in medical technology.
"Allowing refurbished medical devices into the country would have jeopardized the quality of healthcare, disincentivized local innovation, and undermined the spirit of the 'Make in India' initiative," Srivastava said.
Indian manufacturers are making significant strides in research and development, delivering "cutting-edge solutions tailored to our healthcare needs", he said.
"By curbing refurbished imports, we not only protect the integrity of our medical ecosystem but also send a strong message to global investors that India is committed to building a robust, indigenous medical device industry. This move safeguards both the future of healthcare innovation in India and the well-being of our patients," he added.