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TGA and industry presentations - Devices Sponsor Information Day, 15 October 2015
Presentations by TGA and Industry (combined) to help sponsors and manufacturers better understand the regulation of medical devices and in-vitro diagnostic medical devices.
- Plenary: Developments in medical device regulation
- Session 1: Conformity assessment
- Session 2: Clinical evidence - pre-market and post-market
- Session 3A: Medical devices - manufacturer evidence and applications for ARTG inclusion
- Session 3B: Medical devices (IVDs) - application process
- Session 4A: Medical devices - audit assessments
- Session 4B: Medical devices (IVDs) - application audits (technical file reviews)
- Session 5: Post-market
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.