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


The Central Drugs Standard Control Organisation on 13th September 2021 has classified 26 medical devices pertaining to operation theatre such as Distractor/Retractors, Suction system operated by vacuum, Non-sterile Surgical forceps, Warming high-flow infusion pump etc.

These medical devices are classified into risk classes of A, B and C based on the intended use, risk associated with the 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.

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