The Central Drugs Standard Control Organisation on 9th August 2021 has classified 135 medical devices pertaining to ophthalmology such as Adaptometer, Anomaloscope, Aqueous/vitreous humour replacement medium kit, Corneal epithelium trephine, Eikonometer etc.
These medical devices are classified into risk classes of A, B and C based on the intended use, risk associated with device and other parameters as specified under the medical device rules 2017.
Any person who intends to apply for grant of licence in respect of medical devices for import/manufacture for sale or for distribution/ sale, stock, exhibit or offer for sale, may group all or any medical device in accordance with the guidelines to be issued from time to time by the Ministry of Health and Family Welfare in the Central Government, by taking into consideration the technological changes or development in the field of medical devices and in vitro diagnostic medical devices.
