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TGA - Guidance
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Latest posts
Last updated 5 days ago
TGA instructions for disinfectant testing
6 days ago
Guidance on testing of disinfectants and sterilants so they meet quality, safety...
Complying with changes to the Permissible Ingredients Determination
about 1 month ago
Guidance to help sponsors comply with changes to the Permissible Ingredients Determination.
Changing the sponsor of a therapeutic good
about 2 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
about 2 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)
3 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
3 months ago
Guidance for manufacturers and sponsors of personalised medical devices, including health professionals...
Understanding labelling and presentation requirements for listed medicines
4 months ago
Guidance for sponsors (product owners) on the legislative requirements for the presentation...
Complying with the Unique Device Identification requirements for medical devices
5 months ago
Understand the regulatory requirements for supplying UDI compliant medical devices in Australia
Complying with the Unique Device Identification timeframes for medical devices
5 months ago
Timeframes for supplying UDI compliant medical devices in Australia
Advertising requirements for disease education activities
5 months ago
Guidance to help you understand requirements for disease information and advertising.
Understanding requirements for medical devices containing medicinal, microbial, recombinant or animal origin substances
5 months ago
This guidance explains the new regulatory requirements for medical devices containing medicinal...
Australian regulatory guidelines for sunscreens (ARGS)
7 months ago
This Guidance describe the requirements and standards for sunscreens (and their ingredients)...