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Interactive decision tools

Foundation

14 February 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.

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.