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TGA - Guidance
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Latest posts
Last updated 13 days ago
Supplying therapeutic vapes in pharmacies
14 days ago
Learn about the regulatory requirements for dispensing and supplying vapes.
Understanding nitrosamine risk in listed medicines
17 days ago
Information for sponsors and manufacturers on assessing the risk of potential nitrosamine...
Understanding the medical device application audit process
29 days ago
This guidance is for sponsors of applications for inclusion of medical devices...
Understanding selection criteria for medical device application audits
29 days ago
Guidance for sponsors of medical devices seeking to include a medical device...
Reporting of medical device adverse events by healthcare facilities
about 2 months ago
Guidance for healthcare facilities, including information about the requirements for data fields...
TGA instructions for disinfectant testing
2 months ago
Guidance on testing of disinfectants and sterilants so they meet quality, safety...
Complying with changes to the Permissible Ingredients Determination
3 months ago
Guidance to help sponsors comply with changes to the Permissible Ingredients Determination.
Changing the sponsor of a therapeutic good
4 months ago
Guidance for what to do if the sponsor of a therapeutic good...
Determining if your product is a cosmetic, a biological or a blood component
4 months ago
If your product contains human cells and tissues (HCT), this guidance outlines...
Understanding regulatory requirements for in vitro diagnostic (IVD) companion diagnostics (CDx)
5 months ago
Guidance on the regulatory framework for in vitro diagnostic (IVD) companion diagnostics...
Understanding specified articles and excluded products in personalised medical devices regulation
6 months ago
Guidance for manufacturers and sponsors of personalised medical devices, including health professionals...
Understanding labelling and presentation requirements for listed medicines
7 months ago
Guidance for sponsors (product owners) on the legislative requirements for the presentation...