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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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IMDRF consultation: Personalised Medical Devices - Regulatory Pathways
Closed on 24 July 2019
Proposed medical device classification for human cells, tissues and organs storage solutions and IVF media
Closed on 29 April 2019
Proposed new medical device classification for substances introduced into the body via a body orifice or applied to the skin
Closed on 29 April 2019
Proposed changes to the classification of active implantable medical devices and their accessories
Closed on 29 April 2019
Proposed changes to the classification of medical devices used in direct contact with the heart, central circulatory or central nervous systems
Closed on 29 April 2019
Proposed new classification rule for medical devices that administer medicines or biologicals by inhalation
Closed on 29 April 2019
Proposed regulatory scheme for personalised medical devices, including 3D-printed devices
Closed on 31 March 2019
Proposed reclassification of spinal implantable medical devices
Closed on 31 March 2019
Regulation of software, including Software as a Medical Device (SaMD)
Closed on 31 March 2019
Proposal to introduce a Unique Device Identification (UDI) system for medical devices in Australia
Closed on 18 February 2019