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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 scheme for personalised medical devices, including 3D-printed devices
Closed on 31 March 2019
Proposed reclassification of spinal implantable medical devices
Closed on 31 March 2019
Regulation of software, including Software as a Medical Device (SaMD)
Closed on 31 March 2019
Proposal to introduce a Unique Device Identification (UDI) system for medical devices in Australia
Closed on 18 February 2019
Potential reclassification of active medical devices for diagnosis and patient therapy
Closed on 18 February 2019
Changes to a number of definitions and the scope of the medical device regulatory framework in Australia
Closed on 18 February 2019
Medical device cyber security
Closed on 14 February 2019
Proposal for the regulation of IVD companion diagnostics
Closed on 14 December 2018
IMDRF consultation: Terminologies for categorised adverse event reporting
Closed on 12 October 2018
IMDRF consultation: Unique Device Identification system
Closed on 12 October 2018