Manufacturers of the Medical Devices are required to obtain manufacturing license under the provisions of Drugs and Cosmetic (D&C) Act & Rules which is notified by Directorate General of Health Services, Ministry of Health & Family Welfare.
It has been brought to the notice of CDSCO (Central Drugs Standard Control Organization) that the manufacturers of the Medical Device are facing difficulties while establishing facilities for the activities of coating, assembling of components, sterilization etc for devices.
The definition of “manufacture” in relation to the drug(devices) includes any process or part of process for making, altering, ornamenting, finishing, packing, labeling, breaking-up or otherwise, treating or adopting any drug with a view to its sale, as per clause (f) of Section 3 of Drugs and Cosmetic Act, 1940.
CDSCO clarified that the processes like coating, assembling of the components, sterilization of devices etc attracts definition of the “manufacture” under the D&C Act. Therefore, for such activity, the firm is required to obtain manufacturing license under the provisions of Drugs and Cosmetic Act & Rules.