Drugs Controller General India notifies a list of medical devices with their intended use and associated risks; aims to guide the importers and manufacturers of medical devices applying for import or manufacture of such devices

With the aim to provide guidance to importers and manufacturers of medical devices intending to apply for import and manufacture of medical devices, the Central Drugs Standard Control Organisation (“CDSCO”) has issued a list of medical devices classified on the basis of their intended use and the risk associated with use of such devices.

However, the following is clarified:

• A device might have specific intended use as specified by its manufacturer.

• The list is of dynamic in nature and is subject to revision from time to time under the provisions of the Medical Devices Rules, 2017

A copy of the Notification is attached herewith for ease of reference.

Source: Central Drugs Standard Control Organisation