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Interactive decision tools


25 September 2020

We have developed decision tools to help you understand our regulatory requirements and meet your obligations.

It is important to note that the outcome of each decision tool is a guide only and based on the answers you provide throughout the tool.

Is my product a therapeutic good?

To help identify if your product is a therapeutic good, and if so, the type of therapeutic good it is likely to be.

Is my product a medical device?

To assist you in determining if your product is a medical device and should be included in the Australia Register of Therapeutic Goods (ARTG).

What classification is my medical device?

To assist you in determining the classification of your medical device (not including In Vitro Diagnostic devices).

What do I require to have a listed medicine in the ARTG?

To help you understand what is required to have your listed medicine (AUST L) included in the Australian Register of Therapeutic Goods (ARTG).

Which clinical trial scheme should I choose?

To help you determine what scheme is most appropriate for your clinical trial.

What type of GMP application do I require?

To assist you in determining if GMP licensing or certification is required.

To help you understand whether you can advertise a particular therapeutic good to the public.

Mandatory information required in advertising for therapeutic goods

To help you identify what information you must include when advertising therapeutic goods to the public in order for the advertising to comply with the Therapeutic Goods Advertising Code (No.2) 2018 (the Code).

Is my sports supplement a therapeutic good?

To help you determine if your sports supplement is declared to be a therapeutic good.