What is Required
Clinical evidence requirements under Essential Principle 14 for Australian medical devices — what it is, who needs it, and how much is required for each device class.
Clinical Trials in Australia
Regulatory requirements for conducting clinical trials of medical devices in Australia, including the CTN/CTA framework and TGA oversight.
Using Overseas Clinical Data
How overseas clinical data can be used to support Australian medical device applications, including data from CE-marked devices and FDA-approved devices.