On August 23, 2021, the Central Drugs Standard Control Organisation (CDSCO) has issued Classification of Medical Devices pertaining to Dental under the provisions of Medical Devices Rules, 2017. The medical devices, based on the intended use, risk associated with the devices and other parameters.
The list of medical devices (mentioned in the Appendix A in the notification) is subject to the following: –
- General intended use given against each of the devices is for guidance to the applicants intends to furnish application of import or manufacture of medical devices under the provisions of Medical Devices Rules, 2017. However, a device may have specific intended use as specified by its manufacturer.
- The list of dynamic in nature and is subject to revision from time to time under the provisions of the Medical Devices Rules, 2017.
To refer the Classification, click HERE