Working with the TGA
Time & Location
About the Event
Most medical device marketed in Australia needs regulatory approval from the Therapeutic Goods Administration (TGA). In this presentation we cover processes for gaining TGA approval and market access. The risk-based approach to medical device regulation, including software with a therapeutic function, is explained, including evidence that needs to be provided.
We cover the practical steps required to engage with the TGA, work through the regulatory approval process to include your device in the Australian Register of Therapeutic Goods. An overview of how software is regulated is included and will touch on artificial intelligence and cybersecurity.
The webinar is presented by Dr Xin-Lin Goh, Director of the Devices Applications Section and Olivia Reeves Team Leader in the Devices Conformity Assessment Section.