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TGA presentations: Devices Sponsor Information Day, 11 October 2017
Presentations by TGA and Industry (combined) to help sponsors and manufacturers better understand the regulation of medical devices and in-vitro diagnostic medical devices.
- The role of the TGA
- Lifecycle of a medical device
- Medical devices – manufacturer evidence and application for inclusion in the ARTG
- Medical devices – audit assessments
- Clinical evidence
- Conformity assessment
- Post market responsibilities
- Recall of therapeutic goods
- TGA focus and wrap up - What we've done, and what we still need to do
- What's happening in Europe
- Adverse event reporting for medical devices
- Adverse event reports for medical devices - how are they investigated?
- Advertising and Industry
- Conducting post-market reviews - the S.P.E.A.R. process
- Clinical evidence reports – common errors in reports
- Uniform recall procedure for therapeutic goods - new guidance
These presentation papers are provided on the TGA's website solely for the purpose of indicating or suggesting what TGA representatives spoke about to the various conferences and seminars to which it relates. The papers are not legislative in nature and should not be taken to be statements of any law or policy in any way.
The Australian Government Department of Health (of which the TGA is a part) advises that (a) the presentation papers should not be relied upon in any way as representing a comprehensive description of regulatory requirements, and (b) cannot guarantee, and assumes no legal liability or responsibility for, the accuracy, currency or completeness of the information contained in the presentation paper.