DCGI classifies 135 ophthalmology related medical devices and 51 respiratory medical devices under MD Rules
New Delhi, August 11, 2021:
The Drugs Controller General (India) has classified 135 medical devices related to ophthalmology under the provisions of Medical Devices Rules, 2017. In another notice, it has also classified 51 medical devices pertaining to respiratory treatments under the provisions of Medical Devices Rules, 2017, the rule formed to regulate them with respect to the import, manufacture, sale and distribution, and clinical investigation.
The drug regulator listed ophthalmology-related medical devices including automated lens meter (dioptometer), bagolini lens, blepharoplasty scissors, contact lens including coloured contact lens, corneal marker, corneal scissors, corneal shield, diagnostic condensing lens, donor cornea container, euthyscope, eye cup, eye muscle clamp, eye pad, eye spud, eyelid clamp, among others.
The DCGI, in in another notice, listed the medical devices including cerebral oximeter, bulk oxygen concentration system, cough long-term ambulatory recording system, dry powder inhaler, foetal pulse oximeter, oxygen concentrator, gas pipeline/supply system air compressor, hypopnea sensor and alarm, infant apnoea monitor, manual chest percussion, nitrogen monoxide analyser, steam inhaler, stress test treadmill, therapeutic positive pressure breathing ventilator, thoracic suction pump, among others under the Medical Devices Rules.
General intended use given against each of the devices is for guidance to the applicants intended 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.
The drug regulator has earlier classified 112 medical devices pertaining to anaesthesiology and around 208 medical devices in various categories including rehabilitation, physical support, dermatology and plastic surgery and interventional radiology and another 80 in vitro diagnostic medical devices including analysers, instruments and softwares, from mid July, 2021. Phrambiz