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 depend 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 for 2012
|
Location
|
Level |
|
1.1 Introduction to the Regulation of Medical Technology in Australia
Presented by Cliff Spong, MTAA
|
Half day |
17 February |
Sydney |
1 |
|
1.2 Advanced Review of the Regulation of Medical Technology in Australia
Presented by Cliff Spong, MTAA
|
Full day |
20 April
|
Sydney |
2
|
1.3 Quality Management Systems and Conformity Assessment Procedures (QMS & CA)
Presented by Cliff Spong, MTAA; Gary Burgess, TGA;
and Alan Edgecomb, Alan Edgecomb Consulting |
Full day |
Register your interest |
TBC |
1 |
|
1.4 Developing Technical Documentation for Medical Technology
Presented by Ece Smrdelji, SeerPharma
|
Full 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 Louise White, SeerPharma
|
Full day |
Register your interest
|
TBC |
2
|
1.7 Risk Management for Medical Technology
Presented by Louise White, 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 |
Register your interest
|
TBC |
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 |
