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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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- Australian Register of Therapeutic Goods (ARTG) (1) Apply Australian Register of Therapeutic Goods (ARTG) filter
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- Remove Medical devices/IVDs filter Medical devices/IVDs (55)
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- (-) Remove Medical devices/IVDs filter Medical devices/IVDs
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- (-) Remove Therapeutic Goods Administration (TGA) filter Therapeutic Goods Administration (TGA)
- (-) Remove Blood and blood components filter Blood and blood components
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- (-) Remove Medical devices safety filter Medical devices safety
Proposed changes to Required Advisory Statements for Medicine Labels (RASML): Sedating antihistamines
Closed on 18 May 2021
Proposed changes to Required Advisory Statements for Medicine Labels (RASML): Menthol
Closed on 18 May 2021
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
Fees and charges proposal 2021-22
Closed on 17 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
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