This presentation is based on two key objectives:
- To give an understanding of the Australian Therapeutic Goods Administration
- An overview of how to place a device on the Register.
Australia has a regulatory authority known as the Therapeutic Goods Administration (TGA) that was initiated by act of parliament in 2002.
As a regulatory authority the device evaluation process is based on an assessment of risk vs benefit.
The device evaluation is based on harmonisation with EU and follows the certification requirements issued by conformity bodies around the world that issue certification documentation in accordance with 93/42/EEC.
The presentation will give an overall assessment on how to include all levels of devices on the Australian Register of Therapeutic Goods. (ARTG) This is an interesting model that oversees the safety of devices being administered to a population of 25 million people.
Presented by: Roy Hardman