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
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