The Central Drugs Standard Control Organisation on 26th July 2021 has classified 36 medical devices pertaining to cardiovascular such as Cardiopulmonary bypass vascular catheter, cannula, or tubing, Pacing system analyzer, Electrocardiograph, Echocardiograph, Cardiac monitor (including cardiotachometer and rate alarm) etc.
| Safety, quality, and performance of medical devices are regulated under the provisions of the Drugs and Cosmetics Act, 1940. The medical devices are classified based on the intended use, risk associated with the device, and other parameters specified in the first schedule of the Medical Devices Rules, 2017. |
