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TGA Releases Guidelines on the Transition of IVD Medical Devices to New Manufacturer Evidence
Release time：2023-06-26 16:12:43 The author: source:
On July 12, 2023, the Australian TGA issued guidelines for applicants applying for changes to entries in the Australian Register of Therapeutic Goods (ARTG) for medical devices or IVD products, aimed at helping applicants maintain the latest and most accurate information contained in the ARTG.

On July 12, 2023, the Australian TGA issued guidelines for applicants applying for changes to entries in the Australian Register of Therapeutic Goods (ARTG) for medical devices or IVD products, aimed at helping applicants maintain the latest and most accurate information contained in the ARTG.

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This guide states that if you want to correct incomplete or incorrect ARTG entries, you need to apply to TGA in accordance with Section 9D (1) of the 1989 Therapeutic Goods Act, submitting a III/AIMD change, IVD change, or Device Change Request (DCR) application. The information that may need to be changed is shown in the following screenshot:

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If you need to learn more about the "Guidelines for Changing Items 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

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