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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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- Remove Medical devices/IVDs filter Medical devices/IVDs (53)
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- Remove Therapeutic goods regulation filter Therapeutic goods regulation (6)
Proposed refinements to the regulation of medical devices that are substances introduced into the human body via a body orifice or applied to the skin
Closed on 13 August 2021
Proposed refinements to the regulation of personalised medical devices
Closed on 14 July 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
Australian 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