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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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Discussion paper on potential for mandatory reporting of medical device adverse events by healthcare facilities in Australia
Closed on 13 December 2021
Consultation on Draft Guidance: Assistive Technologies and the Therapeutic Goods (Excluded Goods) Determination 2021
Closed on 22 October 2021
Proposed changes to the Permissible Ingredients Determination: Low-negligible risk changes 2021-22
Closed on 15 September 2021
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
Proposed improvements to the Therapeutic Goods Advertising Code
Closed on 18 June 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 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