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.
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.