In order to regulate the safety, quality and performance of medical devices, Drugs Controller General on 6th August 2021 has issued a notification classifying medical devices pertaining to ENT under the provisions of Medical Devices Rules, 2017.
The Drug Controller General has classified 67 medical devices related to ENT including Audiometer testing system, Behind-the-ear airconduction hearing aid, Electroglottograph, Endaural curette, ENT surgical microscope, Flexible fibreoptic nasopharyngo laryngoscope, Nasal septum straightening forceps etc.
The General intended use given against each of the devices is for guidance to the applicants intends 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.
