The Central Drugs Standard Control Organisation on 13th September 2021 has issued a notification classifying medical devices pertaining to personal protective equipment under the provisions of Medical Devices Rules, 2017.
The Drug Controller General has classified 32 medical devices related to personal protective equipment including Garment, Protective for Incontinence, Face shield, Latex surgical glove, Radiation protection gloves, Operator radiation protection spectacles, Gonadal radiation protector etc.
The General intended use given against each of the devices is for guidance to the applicants intend to furnish application of import or manufacture of medical devices under the provisions of Medical Devices Rules, 2017. However, a device may have specific intended use as specified by its manufacturer.
