Australian TGA Regulatory Approval Process for Medical and IVD Devices

To obtain access to the Australian market, medical and in vitro diagnostic (IVD) device manufacturers will need to include their products in the Australian Register of Therapeutic Goods (ARTG), regulated by the Therapeutic Goods Administration (TGA). 

The Australian TGA medical device approval process explained 

The chart illustrates the TGA approval process per device classification in Australia and is available for download in the Regulatory Affairs Management Suite (RAMS). Only a condensed overview of the main steps for registration is provided here. 

Step 1 
Determine the classification of your device according to the Australian classification rules.  

Step 2 
Appoint an Australian Sponsor to manage your device registration and interact with the TGA on your behalf.  

Step 3 
Have current technical documentation and an Australian Declaration of Conformity ready for submission to the TGA. 

Step 4 
Unless your device is in the lowest risk class, your Sponsor submits your Manufacturer’s Evidence for the TGA’s review and acceptance. 

Step 5 
For all devices, your Sponsor submits a medical device application. Pay the application fee. The TGA may review sections of your technical documentation as part of an application audit.  

Step 7 
Upon TGA approval, you will be issued an ARTG listing number and your Sponsor can print the ARTG Certificate of Inclusion from the TGA Business Service website.