This suite of courses covers the process for obtaining marketing approval from the Therapeutic Goods Administration (TGA) for an IVD in Australia. It describes the basics of the regulatory system, the basis of grouping IVDs for inclusion on the Australian Register of Therapeutic Goods (ARTG) and the process of making application for ARTG inclusion. It also explains when overseas approvals can be used to support an application for ARTG inclusion and when a TGA-issued Conformity Assessment Certificate is needed and how to obtain one if necessary. Finally, it will explain the TGA fees and charges involved in making applications for ARTG entry or conformity assessment certification.
Upon completion of this course, trainees will
|Course Title Click on a title to view course description||ID||Duration|
|IVD Australia: Basics for including an IVD on the ARTG||N150||44|
|IVD Australia: The use of GMDN codes for IVDs in Australia||N151||45|
|IVD Australia: Making application for inclusion on the ARTG||N152||33|
|IVD Australia: Obtaining a TGA Conformity Assessment Certificate for IVD devices||N153||40|
|IVD Australia: Fees for including an IVD device on the ARTG||N154||43|