IVD Australia: Fees for including an IVD device on the ARTG
This course examines the fees and charges related to making application to Australia’s Therapeutic Goods Administration (TGA) for a conformity assessment certificate or inclusion of an IVD on the Australian Register of Therapeutic Goods (ARTG). It also describes the provisions available for reduction of fees and the circumstances in which fee reductions may be applicable.
Upon completion of this course, trainees will
- understand the nature and structure of the fees and charges applicable to applications to the TGA; and
- be able to determine whether their application is eligible for reduced fees
Regulatory affairs professionals driving market access for IVDs in Australia.