Import of refurbished medical devices are not allowed – CDSCO
Central Drugs Standard Control Organisation (CDSCO) regulates Quality, Safety and Performance of the Medical Devices under Drugs and Cosmetics Act, 1940 and Medical Devices Rules 2017.
To control the second-hand / unregulated medical devices in the country, recently CDSCO has issued a letter to the Principal Commissioner of Customs, New Delhi, clarifying that No separate license is issued for import of refurbished medical devices in the country. Following points are covered in the communication
- All the Medical Devices are regulated under Medical Devices Rules 2017
- However, there is no specific provision for regulation of refurbished medical devices under the said Medical Devices Rules 2017
- Hence no license is issued for import of such devices and it cannot be imported in the country under Medical Devices Rules 2017 for sale and distribution.
