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.
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.