The Central Drugs Standard Control Organization (CDSCO) on October 25, 2023, issued a notification regarding the Classification of In-vitro Diagnostic Medical Devices under the provisions of Medical Devices Rules, 2017.
The following has been stated namely: -
• The updated list of In-vitro Diagnostics Medical Devices placed as Annexure A (Updated), Annexure B (Updated), Annexure C, Annexure D, and Annexure E is subjected to the following namely: -
(i) It states that the General intended use given against each of the devices is for guidance to the applicants who intend to furnish an application of import or manufacture of medical devices under the provisions of Medical Devices Rules, 2017. However, the device may have specified intended use as specified by its manufacturer.
(ii) It states that the list is dynamic and is subjected to revision from time to time under the provisions of the Medical Devices Rules, 2017
[Notification No. IVD/Misc/196/2020]
