IVD Australia: Making application for inclusion on the ARTG
Course Description:
This course examines the process for making an application to include an IVD device on the Australian Register of Therapeutic Goods (ARTG), and the requirements for the manufacturer’s certification and review of the application by the TGA. It explains steps needed either with a positive or negative response from the TGA, and outlines the ongoing responsibilities of the manufacturer once an IVD device is included on the ARTG.
Learning Objectives:
Upon completion of this course, trainees will:
- understand the process, requirements and responsibilities for making an application to include an IVD device on the ARTG
- know what documents the TGA will request to support an application for each class of IVD devices.
Who Should Enroll:
Regulatory affairs managers, quality assurance managers and marketing managers driving market access for IVDs in Australia.
Prerequisite Knowledge/Requirements:
IDN150 - Basics for Including an IVD on the ARTG
IDN151 - The Use of GMDN Codes for IVDs in Australia