“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.
Gaurav Agarwal, Managing Director, Innvolution Healthcare, said that CDSCO’s decisive clarification reinforces the regulatory framework designed to ensure the highest standards of patient safety while creating a robust environment for the growth of indigenous manufacturing.
“By eliminating ambiguity, CDSCO has further strengthened the push towards self-reliance, innovation, and quality in India’s medical technology sector, perfectly aligning with the ‘Make in India’ and ‘Atmanirbhar Bharat’ initiatives.
Innvolution Healthcare remains committed to supporting these national objectives by delivering cutting-edge, locally manufactured solutions that enhance healthcare delivery and patient outcomes. We look forward to continued collaboration with regulators and stakeholders to advance India’s position as a global leader in medical technology,” Agarwal said.
Vishwaprasad Alva, Founder and Managing Director, Skanray Technologies, said that import of used medical equipment was an error that the government corrected.
“…It’s the right move. India being a large nation and a growing market, apart from becoming a dumping ground for old unsafe medical equipment, we would have also become an e-waste destination for the world. The government seems to be sensitive and serious about world class healthcare and also helping homegrown manufacturing and research and development infrastructure,” Alva said.
