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The Australian Government is undertaking a significant program of reform to improve the safety, performance, and quality of medical devices in Australia and improve health outcomes for patients who require medical devices. As part of the Australian Government Department of Health, the...More
The Therapeutic Goods Administration (TGA) is seeking feedback on potential options for the regulation of biological therapeutic goods (biologicals) manufactured in Australia for export only (and not for supply in Australia).
Biologicals are human tissue and cell-derived products...More
From 19 October 2020, how the TGA engages with the sponsors for post market reviews has changed. A new medical device Post Market Review Compliance Dashboard has been developed in TBS to respond to post market reviews. The new compliance dashboard will provide the sponsors with an efficient...More
The TGA is seeking feedback on how effectively information relating to the results of listed medicine compliance reviews is being conveyed to consumers.
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The Therapeutic Goods Legislation Amendment (2019 Measures No.1) Regulations 2019 was made on 12 December 2019 to include the reclassification of motion-preserving devices (such as spinal disc replacements and devices used to help restore the normal motion of the spine) and spinal ...More
This form is no longer in use. Please refer to the TGA website to complete an application for consent to import, supply, or export a medical device that does not comply with the Essential Principles.
There are Criminal Offences under S41MA and Civil Penalties under S41MAA...More
This form is no longer in use. Please refer to the TGA website to complete an application for consent to import, supply, or export a medical device that does not comply with the Essential Principles.
There are Criminal Offences under S41MA and Civil Penalties under S41MAA of the ...More
Scheduling amendments referred to expert advisory committee
This consultation is for interim decisions made in relation to applications and delegate initiated proposals to amend the Poisons Standard, following advice sought at the 23 June 2021 meetings of the Advisory Committee on Medicines...More
Scheduling amendments referred to expert advisory committee
This consultation is for interim decisions made in relation to applications and delegate initiated proposals to amend the Poisons Standard, following advice sought at the 23 June 2021 meetings of the Advisory Committee on Medicines...More
Scheduling amendments referred to expert advisory committee
This consultation is for interim decisions made in relation to applications and delegate initiated proposals to amend the Poisons Standard, following advice sought at the 22 June 2021 meeting of the Advisory Committee on Chemicals...More