This notification form is for Australian manufacturers or sponsors of clinical decision support software, that meet the exemption criteria outlined in the Therapeutic Goods (Medical Devices) Regulations 2002 .
The exemption applies to medical devices that are clinical...More
Please use this form to notify the TGA of any lapsing or lapsed manufacturer’s conformity assessment certification for your medical device(s).
Conformity assessment certification may lapse due to the certification expiring, or if it has been suspended or revoked. ...More
This tool is for sponsors or agents of non-IVD medical devices included in the ARTG with a need to transition from the EU MDD to the new EU MDR to allow medical devices to continue to be supplied in Australia.
This tool will assist you to determine what actions you may or may not need to...More
This form is for sponsors or agents of non-IVD medical devices included in the ARTG with a need to transition from the EU MDD to the new EU MDR to allow medical devices to continue to be supplied in Australia.
Complete this form if you are a sponsor or agent seeking to utilise TGA’s web...More
This is the new version of the form: Application to amend the Poisons Standard.
Help us improve it by providing your feedback via email to the Scheduling Secretariat .
This form contains notes on each page to help you navigate through the sections. You can expand the ‘More...More
Prior to February 2021, most medical devices that were designed and manufactured to suit an individual patient/client were known as “custom-made” medical devices. These kinds of devices were not required to have TGA approval or to be included in the Australian Register of Therapeutic...More
Prior to February 2021, most medical devices that were designed and manufactured to suit an individual patient/client were known as “custom-made” medical devices. These kinds of devices were not required to have TGA approval or to be included in the Australian Register of Therapeutic...More
Prior to February 2021, most medical devices that were designed and manufactured to suit an individual patient/client were known as “custom-made” medical devices. These kinds of devices were not required to have TGA approval or to be included in the Australian Register of Therapeutic...More
Prior to February 2021, most medical devices that were designed and manufactured to suit an individual patient/client were known as “custom-made” medical devices. These kinds of devices were not required to have TGA approval or to be included in the Australian Register of Therapeutic...More
The Therapeutic Goods Administration (TGA) is conducting a public consultation to provide industry and other interested stakeholders with an opportunity to comment on the TGA's proposed fees and charges for the 2023-24 financial year. Specifically, we are seeking feedback on the potential...More
The Therapeutic Goods Administration (TGA) is seeking feedback on improvements to the therapeutic goods recalls process.
In Australia, recalls should be done in accordance with the procedures in our guidance document - the Uniform Recall Procedure for Therapeutic Goods...More
Interim decisions regarding substances discussed at the expert advisory meetings.
Please note that this consultation is for the interim decision in relation to paracetamol only . If you wish to comment on the interim decisions for other substances discussed at the November 2022 meetings,...More
Interim decisions regarding substances discussed at the expert advisory meetings.
Please note that this consultation is for substances other than paracetamol. If you wish to comment the proposed interim decision in relation to paracetamol please see the link below:
Consultation...More
This is the new version of the form: Application to amend the Poisons Standard.
Help us improve it by providing your feedback via email to the Scheduling Secretariat .
This form contains notes on each page to help you navigate through the sections. You can expand the ‘More...More
On 24 December 2021 several changes to the Narcotic Drugs Act 1967 came into effect, including the introduction of a single licence model for cultivation, production and/or manufacture activities. At this time the Office of Drug Control (ODC) also implemented simpler permit processes and...More
Scheduling amendments referred to expert advisory committee
This consultation is for applications and delegate initiated proposals to amend the Poisons Standard. The scheduling amendments and any submissions received will be considered at the March 2023 meetings of the ...More
Welcome
You are now on the Australian Unique Device Identification Database ( AusUDID) Sandpit registration page.
You can return to the UDI Hub to view other AusUDID information at any time.
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The Office of Drug Control Monitoring and Compliance Section is seeking feedback on its operational performance and engagement with Medicinal Cannabis Licence holders. The medicinal cannabis industry’s feedback will help the Monitoring and Compliance Section meet stakeholders expectations in...More
The Therapeutic Goods Administration (TGA) is seeking public comment on potential reforms to the regulation of nicotine vaping products (NVPs) in Australia.
The potential reforms are aimed at preventing children and adolescents from accessing NVPs, while supporting access to...More
The Therapeutic Goods Administration (TGA) is seeking views on medicine ingredient names that must be displayed as both the old and new ingredient name ('dual labelled') on labels and Product Information (PI) and Consumer Medicine Information (CMI) documents until 30 April 2023 as part of ...More
From 1 December 2021, the application for consent to import, supply, or export a medical device that does not comply with the Essential Principles has moved to the TGA Business Services (TBS) portal. The new form will provide stakeholders with a more efficient way of submitting an application to...More
Scheduling amendments referred to expert advisory committee
Please note: this is a consultation for the interim decisions relating to PSILOCYBINE and MDMA ONLY. If you wish to provide comments on the other items considered at the ACMS and ACCS meetings in June 2022, please visit the...More
Scheduling amendments referred to expert advisory committee
Please note that there is a separate consultation for interim decisions relating to PSILOCYBINE and MDMA which can be found by clicking the link below:
Psilocybine and MDMA consultation
This consultation is for...More
The Therapeutic Goods Administration (TGA) is seeking feedback on the draft guidance ‘Boundary and combination products - medicines, medical devices, and biologicals ’ .
The purpose of this draft guidance is to assist sponsors and manufacturers in determining the status of...More
The Therapeutic Goods Administration (TGA) is seeking feedback on whether or not certain international scientific guidelines should be adopted.
Prior to adopting any international scientific guideline, the TGA undertakes an extensive process of internal and external...More
The Therapeutic Goods Administration (TGA) is considering regulatory options to allow advertisers, including product sponsors, to make references to the TGA in advertising (including on product labels).
We are seeking feedback on:
whether references to the TGA should...More
The Database of Adverse Event Notifications (DAEN) – medicines is the TGA’s public database displaying information about reports of suspected adverse events received in relation to medicines (including vaccines) and biological therapies in Australia.
The TGA have created a...More
Potential Scheduling amendments referred to expert advisory committee.
Please note that this consultation is for paracetamol only. If you wish to comment on other substances discussed at the November 2022 meetings, please see the link below:
Consultation for November...More
The Australian Government is undertaking a significant program of reform to the regulation of therapeutic goods in Australia. The reforms will continue to improve the safety, performance, and quality of medical devices in Australia and improve health outcomes for patients who require medical...More
The Therapeutic Goods Administration (TGA) is requesting feedback on the current usage of the information included with boxed injectables and whether the requirement to include a paper Product Information (PI) as a package insert in boxed injectables is still relevant for those administered by...More