In-vitro Diagnostic Medical Devices classified based on the intended use and the risk involved

Directorate General of Health Services vide a notice dated 23rd July,2021, has classified the In-vitro Diagnostic Medical Devices based on the intended use, the risk involved and other parameters specified in the First Schedule of Medical Devices Rules,2017. The list of In-vitro Diagnostic Medical Devices placed at Annexure A, Annexure B and Annexure C is subjected to the following:

1. General intended use given against each of the device is for guidance to the applicants who intends to furnish application of import or manufacture of medical devices under the provisions of Medical Devices Rules,2017. However, a device may have specified intended use as specified by its manufacturer.
2. This list is dynamic and is subjected to revision from time to time under the provisions of the Medical Devices Rules, 2017.