CDSCO classifies medical devices pertaining to Neurological under the provisions of Medical Devices Rules, 2017.

The Central Drugs Standard Control Organisation on 27th September 2021 has classified 110 medical devices pertaining to Neurological such as Analytical nonscalp cutaneous electrode, Behavioural therapy electrical stimulation
system, Cerebral perfusion catheter, Cortical electrode 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.