The Australian Regulatory System for In-Vitro Diagnostic (IVD) Devices
This course concentrates on the Australian risk-based regulatory system covering IVDs, which is modeled after the GHTF/IMDRF guidance and came into effect 1 July 2010. It consists of four parts and includes both pre- and post-approval requirements for manufacturers, sponsors, importers, and exporters of IVDs.
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Upon successfully completing this course, trainees will be able to:
- Comprehend and define the fundamentals of the Australian Regulatory System for IVDs, which includes:
- Background of the Australian Medical Device industry
- Structure of Australian legislation
- Basics of EU medical device directives compared to those of Australia
- Regulatory authority
- Pre-market approval process
- Documentation and procedural requirements for conformity assessment
- Conformity assessment routes
- Listings on the Australian Register of Therapeutic Goods (ARTG)
- Essential principles compared to essential requirements
- Post-market obligations
Regulatory Affairs Associate, Regulatory Affairs Manager, Quality Assurance Associate, Quality Assurance Manager, Quality Assurance Engineer, Manufacturing Engineer, Supply Manager, Purchasing Manager, Design Engineer, Validation Engineer, Electrical Safety Engineer, Internal Auditor, Lead auditor, Pre-Clinical Study Manager, Export Manager, Clinical Affairs Director, and R&D Engineer who work specifically with IVDs are encouraged to enroll in this course. In addition, laboratory and pathology workers may find this course useful as it relates to current in-house laboratory tests regulated in Australia.
There is no prerequisite knowledge required for this course; all areas of expertise are welcome.