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.
To eventually supply a medical device, sponsors need to submit a market authorisation application to the Therapeutic Goods Administration (TGA) to include their medical device in the Australian Register of Therapeutic Goods (ARTG).
This guidance provides:
- a summary of the medical device life-cycle
- an overview of what to consider during the design and development phase
- an overview of the pre-market (application preparation) phase
- a guide to compiling your clinical evidence
Only therapeutic goods can be entered in the ARTG. If you are unsure whether you have a therapeutic good, use the Is my product a therapeutic good? decision tool on the TGA website…