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TGA - Guidance
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Latest posts
Last updated 9 days ago
Manufacturing, supplying and advertising compounded medicines lawfully
9 days ago
Guidance on the legislative framework that applies to manufacturing, advertising and supplying...
Using assessments from comparable overseas regulators for medical devices
12 days ago
Guidance on the use of market authorisation evidence from comparable overseas regulators...
Manufacturing bacteriophages products in Australia
25 days ago
Guidance on when a manufacturing licence is required for bacteriophage therapy products...
Understanding activities that represent advertising
about 2 months ago
Guidance about when information released to the public about therapeutic goods is...
Advertising software-based medical devices in Australia
about 2 months ago
Guidance about the requirements for advertising software-based medical devices to consumers or...
Understanding the clinical workflow management software exclusion
2 months ago
Guidance on when software used for clinical workflow management may be excluded...
Understanding the image storage and transmission software exclusion
2 months ago
Guidance on when software products with the sole purpose of storing or...
Understanding the calculator software exclusion
2 months ago
Guidance on when software that makes calculations may be excluded from our...
Understanding the digital mental health tool software conditional exclusion
2 months ago
Guidance on when consumer software products like apps or websites intended to...
Understanding the health facility management software exclusion
2 months ago
Guidance on when software used for the administration or management of health...
Understanding the behavioural change or coaching software exclusion
2 months ago
Guidance on when consumer software products that encourage behavioural change to improve...
Understanding the health self-management software exclusion
2 months ago
Guidance on when software products for consumers to self-manage an existing disease...