IVD Australia: Fees for Including an IVD Device on the TGA or ARTG
Course Description:
This course examines the fees and charges related to making applications to either the Australian Therapeutic Goods Administration (TGA) for conformity assessment certificates or the Australian Register of Therapeutic Goods (ARTG) for the inclusion of IVDs. It also describes the provisions available for reduced fees and the circumstances in which they may be granted.
Learning Objectives:
Upon successfully completing this course, trainees will be able to:
- Understand the nature and structure of fees and charges for TGA and ARTG applications
- Determine whether an application is eligible for reduced fees
Who Should Enroll:
Regulatory affairs professionals driving market access for IVDs in Australia are encouraged to enroll in this course.
Prerequisite Knowledge/Requirements:
The following courses are required:
- IVD Australia: Basics for Including an IVD on the ARTG (ID N150)
- IVD Australia: The Use of GMDN Codes for IVDs in Australia (ID N151)
- IVD Australia: Making Applications for Inclusion on the ARTG (ID N152)
- IVD Australia: Obtaining a TGA Conformity Assessment Certificate for IVD Devices (ID N153)