Course Description

IVD Australia: Basics for including an IVD on the ARTG

Course Description:

This course reviews the process of including IVDs on the Australian Register of Therapeutic Goods (ARTG). It introduces the ARTG, explains the responsibilities of sponsors and manufacturers, and illustrates how both Australian and overseas manufacturers provide evidence for conformity.

Links to regulatory guidance documents are given at the end of the course.

Learning Objectives:

Upon successfully completing this course, trainees will be able to:

  • Plan the market access strategies of IVDs in Australia with respect to ARTG inclusion
  • Interpret regulatory requirements and use suitable guidance

Who Should Enroll:

Regulatory affairs professionals driving market access for IVDs in Australia are encouraged to enroll in this course.

Prerequisite Knowledge/Requirements:

Comprehension of the Australian market access process for IVDs, the basic principles of the GHTF regulatory system, and the significance of essential principles for safety, performance, and risk management is required for this course.

Subject Matter Expert:

44 min

Related resources:

Case studies:

Basic Account: € 194.00
Premium Account: € 145.00

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