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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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IMDRF consultation: Proposed update to document on Post-Market Clinical Follow-Up Studies
Closed on 11 December 2020
Proposed enhancements to adverse event reporting for medical devices
Closed on 2 December 2020
IMDRF consultation: Competence and Training Requirements for Regulatory Authority Assessors of Conformity Assessment Bodies
Closed on 26 May 2020
Scope of Regulated Software based products
Closed on 13 May 2020
IMDRF consultation: Recognition and Surveillance of Medical Device Conformity Assessment Bodies
Closed on 9 May 2020
Export of therapeutic goods from Australia
Closed on 3 February 2020
Review of the regulation of certain self-testing IVDs in Australia
Closed on 6 December 2019
Proposed clarification of the regulatory requirements for medical device systems and procedure packs
Closed on 31 October 2019
Products used for and by people with disabilities
Closed on 25 October 2019
Proposed changes to medical device essential principles for safety and performance
Closed on 17 October 2019