IVD Australia: Basics for including an IVD on the ARTG
This course reviews the process of including IVDs on the Australian Register of Therapeutic Goods (ARTG). It introduces the ARTG, explains the responsibilities of sponsors and manufacturers, and illustrates how both Australian and overseas manufacturers provide evidence for conformity.
Links to regulatory guidance documents are given at the end of the course.
Watch the Course Trailer:
Upon successfully completing this course, trainees will be able to:
- Plan the market access strategies of IVDs in Australia with respect to ARTG inclusion
- Interpret regulatory requirements and use suitable guidance
Regulatory affairs professionals driving market access for IVDs in Australia are encouraged to enroll in this course.
Comprehension of the Australian market access process for IVDs, the basic principles of the GHTF regulatory system, and the significance of essential principles for safety, performance, and risk management is required for this course.
For more information on the topics above, please review the following course:
- The Australian Regulatory System for In Vitro Diagnostic (IVD) Devices (ID 132)