Health Ministry says no to import of refurbished medical devices

NEW DELHI: In a move to check the influx of refurbished medical devices, which pose serious risks to the medical sector, including diagnostics, the Union Health Ministry has directed the Customs Department to halt the import of such devices into the country.

The Central Drugs Standard Control Organisation (CDSCO) wrote to the Principal Commissioner of Customs, clarifying that there is no provision for regulating refurbished medical devices under the Medical Devices Rules, 2017. "Hence, no license is issued for the import of such devices, and they cannot be imported into the country under the Medical Devices Rules, 2017, for sale and distribution," the Deputy Drugs Controller stated in an order last week.

Welcoming the government’s directive, Dr. Sudhir Srivastava, former Chair of the Medical Device Committee at PHDCCI, said the decision marks a "pivotal step towards reinforcing India’s self-reliance in medical technology." He added that allowing refurbished medical devices into the country would have jeopardised the quality of healthcare, disincentivised local innovation, and undermined the spirit of the ‘Make in India’ initiative. “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,” Dr. Srivastava said. Lauding the clarity provided by the government, Gaurav Agarwal of Innvolution Healthcare said the directive reinforces the regulatory framework designed to ensure the highest standards of patient safety while fostering an environment conducive to the growth of indigenous manufacturing.

By eliminating ambiguity, the CDSCO has further strengthened the push towards self-reliance, innovation, and quality in India’s medical technology sector, Agarwal stated.

Vishwaprasad Alva, founder of Skanray Technologies, noted that the import of used medical equipment was a significant oversight that the government has now corrected. “India, being a large nation and a growing market, would have not only become a dumping ground for old, unsafe medical equipment but also an e-waste destination for the world. The government seems to be both sensitive and serious about providing world-class healthcare while supporting homegrown manufacturing and R&D infrastructure,” he said.