The Australian TGA released guidance on July 12, 2023 for sponsors applying to make changes to entries in the Australian Register of Therapeutic Goods (ARTG) for medical devices or IVD products. It is intended to help sponsors maintain the information contained in the ARTG. is the latest and most correct.

This guidance states: If you wish to correct an incomplete or incorrect ARTG entry, you will need to apply to the TGA under section 9D(1) of the Therapeutic Goods Act 1989 to submit a III/AIMD variation, IVD variation or device variation request (DCR) application. The information that may need to be changed is as shown in the screenshot below:

If you need more information about the "Guidelines for Changes in Entries of Medical Devices and IVD Products in ARTG", please refer to the guide link:

https://www.tga.gov.au/sites/default/files/2022-10/varying-entries-in-the-artg.pdf