“There is no specific provision for regulation of refurbished medical devices under the Medical Devices Rules 2017. Therefore, there is no specific provision for the import of such devices,” CDSCO said in a letter to the office of the Principal Commissioner of Customs in New Delhi. No license is issued, and they cannot be imported into the country for sale and distribution.”
The Association of Indian Medical Device Industry (AIMED) argued that the country's healthcare security is already at risk, as about 70 percent of the current medical device requirements are being met through imports. Without any regulatory control these Imports have further threatened the sector, as it is estimated that about 60 per cent of medical electronic equipment imports worth Rs 40,000 crore are pre-owned devices being dumped in India.
Rajeev Nath, Forum Coordinator, AIMED, said, “We welcome multinational companies to invest in India and make high technology devices and make them affordable for Indian patients, as is being done in the mobile phone and automobile sectors. A healthy competition is welcome.” Domestic medical device manufacturers have been protesting against the import of second-hand medical devices for several months. They say the import of refurbished and used medical equipment is against the government's policy of encouraging “self-reliance”, despite similar equipment being manufactured in India.
