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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.
Trove at the National Library of Australia has information on archived TGA consultations and reviews.
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Proposed regulatory changes related to personalised and 3D printed medical devices
Closed on 22 December 2017
Alignment with European medical device regulatory framework
Closed on 25 August 2017
Comparable overseas regulators - medical devices
Closed on 30 June 2017
Designation of Australian conformity assessment bodies for medical devices - Implementation
Closed on 11 January 2017
Accelerated assessment of medical devices - Priority Review pathway - Implementation
Closed on 11 January 2017
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