IVD Australia: Making Applications for Inclusion on the ARTG
Course Description:
This course examines the process of creating applications for IVD devices on the Australian Register of Therapeutic Goods (ARTG). It also reviews the requirements for manufacturer certification and the TGA application process.
Additionally, this course explains the necessary course of action when given either a positive or negative response from the TGA, and also outlines the ongoing responsibilities of the manufacturer once an IVD device has been included on the ARTG.
Learning Objectives:
Upon successfully completing this course, trainees will be able to:
- Understand the process, requirements, and responsibilities needed to create an application that includes IVD devices on the ARTG
- Identify which documents the TGA needs to support applications 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 are all welcome 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)