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Regulation of Medical Technology

Course 1: Medical Technology Regulation & Clinical Activities

The regulation of medical technology in Australia is similar, in principle, to that adopted in the European Union.  However, there are differences. The Therapeutic Goods Administration (TGA) regulates the supply of therapeutic goods in Australia, including medical technology.  Before a sponsor can supply items of medical technology in Australia, the TGA has to grant an approval and enter the product in the Australian Register of Therapeutic Goods (ARTG). A range of modules support this area of learning.

Registration for this course will be only be offered to those that express an interest to attend a module. Please click on 'Register Your Interest' and include with the module title your name, preferred location, phone and email address. The city location of the training will be dependent on where the majority of those that have expressed an interest are based.

To learn about the MTAA training level descriptors, please click here. For a summary of module fees, please click here.

Click on the module title and/or presenter for more information. 

* The following overview may be subject to change.  Please click on the link to register.

Module	Duration	Register Your Interest for 2010	Location	Level
1.1 Introduction to the Regulation of Medical Technology Presented by Cliff Spong, MTAA	Half day	Register Your Interest	TBC	1
1.2 Advanced Review of the Regulation of Medical Technology in Australia Presented by Cliff Spong, MTAA	Full day	Register Your Interest	TBC	2
1.3 Quality Management Systems and Conformity Assessment Procedures (QMS & CA) Presented by Cliff Spong, MTAA and Alan Edgecomb	Full day	Register Your Interest	TBC	1
1.4 Developing Technical Documentation for Medical Technology Presented by Steve Williams, SeerPharma	Half day	Register Your Interest	TBC	1
1.5 Understanding Clinical Evidence for Medical Technology Presented by Cliff Spong, MTAA	Half day	Register Your Interest	TBC	1
1.6 Risk Analysis and the Development of Medical Technology Presented by Steve Williams, SeerPharma	Full day	Register Your Interest	TBC	2
1.7 Risk Management for Medical Technology Presented by Steve Williams, SeerPharma	Full day	Register Your Interest	TBC	2
1.8 Introduction to the Regulation and Design of Clinical Investigations for Medical Technology in Australia  Presented by Stefan Czyniewski, Dr Martin Devitt and Suzanne M. Williams, Mobius Medical	Full day	6 September	Sydney	1
1.9 Improving Your Clinical Investigations for Medical Technology Presented by Stefan Czyniewski, Dr Martin Devitt, Professor Val Gebski and Suzanne M. Williams, Mobius Medical	Half day	Register Your Interest	TBC	2
1.10 Biohazards & Sterilisation Presented by Louise White, SeerPharma	Half day	Register Your Interest	TBC	1

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