Course Description

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:

Subject Matter Expert:

33 min

Related resources:

Case studies:

Basic Account: € 145.00
Premium Account: € 109.00

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