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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: Assessment and Decision Process for the Recognition of a Conformity Assessment Body Conducting Medical Device Regulatory Reviews
Closed on 19 April 2021
Proposed regulatory options for medical devices containing nanomaterials
Closed on 9 April 2021
Proposal for clarifying regulatory requirements for residual claims for disinfectants
Closed on 26 March 2021
Proposal to remove redundant processes for entering certain formulation information into a therapeutic goods application
Closed on 24 February 2021
Australian Medical Device Regulations definition of Central Circulatory System (CCS)
Closed on 10 February 2021
Exploring options for the introduction of an Australian Unique Device Identification (UDI) System
Closed on 24 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