IVD Australia: Basics for including an IVD on the ARTG
This course provides regulatory and quality professionals with a detailed review of the process of inclusion of an IVD on the Australian Register of Therapeutic Goods (ARTG). We provide an introduction to the ARTG, explain the responsibilities of sponsors and manufacturers, and show you how Australian and overseas manufacturers can provide evidence for conformity. Links to regulatory guidance documents are given at the end of this course.
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Upon completion of this course, trainees will be able to correctly and successfully:
- Plan market access of IVDs in Australia with respect to the ARTG inclusion
- Interpret regulatory requirements and use the applicable guidance.
Regulatory affairs professionals driving market access for IVDs in Australia
Comprehension of the Australia market access process for IVD and the basic principles of GHTF regulatory system.
Understanding the significance of the essential principles for safety and performance, and those for the risk management process.
For more information on the above knowledge points, please see the following course: