As a researcher of a new therapeutic good, including medicines, medical devices and biologicals, we encourage you to familiarise yourself with the regulatory requirements early in the product life-cycle.
When it comes time to apply to TGA for market authorisation and have your product added to the Australian Register of Therapeutic Goods (ARTG), you will be required to provide or hold evidence to demonstrate quality, safety and efficacy based upon the type of therapeutic good.
Generally, the higher the level of risk your product poses, the more evidence you will be required to obtain. You can find an overview of the way TGA considers risks and benefits during evaluation at Product regulation according to risk.
For information about what to consider as a researcher developing a new product:
- Researcher considerations for medical devices - this guidance assists researchers of new medical devices, including in vitro diagnostic (IVD) medical devices and software as a medical device (SaMD), to understand the evidence requirements for market authorisation.