The Australian Regulatory System for In-Vitro Diagnostic (IVD) Devices
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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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
- Listing on the Australian Register of Therapeutic Goods (ARTG)
- Essential Principles vs. Essential Requirements
- Post-Market obligations
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.