DCGI – Notifies classification of 60 medical devices

New Delhi – The Drug Controller General of India (DCGI) has issued a notification classifying 60 medical devices pertaining to rehabilitation under the provisions of Medical Devices Rules, 2017. The DGCI classifies the device as A,B,C & D depending on the risk associated with the device. The risk associated with the Class A is perceived to be low, while B has low to moderate risk, C has moderate to high risk and D has the high risk, according to the widely accepted classification criteria.

The decision of DGCI, the drug regulator of the country is classifying the medical devices sold in the country based on the perceived risk of the product type and its use in patients. The measure is to help the authority to bring in all the medical devices under the regulatory control. In July, the drug regulator classified a group of 70 medical devices pertaining to rehabilitation. Some of the same devices are mentioned in the new notice issued on August 4, also. None among the 60 devices were classified as Class D of the regulation.