The Drugs Controller General India (DCGI) on Oct 11, 2022, hereby classifies medical devices pertaining to Oncology under the provisions of Medical Devices Rules, 2017.
Appendix A based on the intended use of the device, risk associated with the device, and other parameters specified in the First Schedule, is attached to the document.
The updated list of medical devices placed in Appendix A subjected to the following-
1. 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.
2. This list is dynamic and is subject to revision from time to time under the provisions of the Medical Devices Rules, 2017.
[Notification No. 29/Misc/03/2020-DC (153) - Part 1]
