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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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Regulation of software, including Software as a Medical Device (SaMD)
Closed on 31 March 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
Proposal to introduce a Unique Device Identification (UDI) system for medical devices in Australia
Closed on 18 February 2019
Medical device cyber security
Closed on 14 February 2019
Proposed amendments to the Poisons Standard - ACCS meeting, March 2019
Closed on 8 February 2019
Proposed amendments to the Poisons Standard - ACCS, ACMS and Joint ACCS/ACMS meetings, March 2019
Closed on 21 January 2019
Regulatory options for appropriate access and safety controls for alkyl nitrites
Closed on 15 January 2019
Proposal for the regulation of IVD companion diagnostics
Closed on 14 December 2018
Referral of proposed amendment to the current Poisons Standard to the meeting of the ACMS, March 2019
Closed on 31 October 2018