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Consultations
We conduct public consultations as part of our broader stakeholder engagement work, including on changes to regulatory requirements or practices, reviews of business processes, standards or guidelines, and TGA fees and charges.
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Software as a Medical Device (SaMD): Clinical Evaluation
Closed on 2 December 2016
Draft clinical evidence guidelines - Medical devices
Closed on 10 June 2016
Software as a Medical Device (IMDRF Working Group)
Closed on 27 May 2015
Proposed performance requirements and risk mitigation strategies for HIV tests
Closed on 30 January 2015
Software as a medical device (IMDRF working group)
Closed on 31 May 2014
Supply of in vitro diagnostic devices for self-testing (home testing) for the presence of human immunodeficiency virus in Australia
Closed on 6 May 2014
Proposed amendments to the new regulatory framework for In Vitro Diagnostic medical devices (IVDs)
Closed on 7 June 2013
Regulation Impact Statement: Changes to premarket assessment requirements for medical devices
Closed on 3 June 2013
Reforms in the medical devices regulatory framework
Closed on 17 December 2010
Draft guidance on the regulation of custom made medical devices
Closed on 31 March 2009