Course Description

The Australian Regulatory System for In-Vitro Diagnostic (IVD) Devices

Course Description:

In Australia, a risk-based regulatory system modeled on the GHTF covering IVDs came into effect on 1st July 2010. This course consists of 4 parts covering both pre and post-approval requirements for manufacturers, sponsors, importers and exporters of IVDs.

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Learning Objectives:

Upon completion of this course, trainees will be able to correctly and successfully comprehend and define the working fundamentals of the Australian Regulatory System for IVDs including;

  • Background of the Australian Medical Device Industry
  • Structure of Australian legislation
  • Basics/background of the EU vs. AUS medical device directives
  • Regulatory Authority
  • Pre-Market Approval Process
  • Documentation & Procedural Requirements for Conformity Assessment
  • Conformity assessment routes
  • Classification
  • Listing on the Australian Register of Therapeutic Goods (ARTG)
  • Essential Principles vs. Essential Requirements
  • Applications
  • Labeling
  • Post-Market obligations
  • Recalls
  • Advertising

Who Should Enroll:

This course is directed to the Medical Device Professional who works specifically with in-vitro diagnostic devices (or IVDs). Laboratory/pathology users will likely also find this course useful, specifically with reference to how in-house laboratory tests are now regulated in Australia.

Prerequisite Knowledge/Requirements:

Subject Matter Expert:

80 min

Release date:

Related resources:

Case studies:

Basic Account: € 390.00
Premium Account: € 293.00

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