4 results
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Proposed changes to the Permissible Ingredients Determination: Low-negligible risk changes 2024-25
The Therapeutic Goods Administration (TGA) is seeking feedback from interested parties on the proposed low-negligible risk changes to the Permissible Ingredients Determination . The proposed changes address the following issues: Herbal ingredients with pregnancy contraindications and other toxic effects Garcinia species, hydroxycitric acid, hydroxycitrate complex and salts, and risk of liver injury Xanthium species ... MoreCloses 13 September 2024 -
Review of draft guidance - Regulatory changes for medical devices containing medicinal substances or materials of animal, microbial or recombinant origin
The Therapeutic Goods Administration (TGA) is seeking feedback on a new guidance document ‘ Regulatory changes for medical devices containing medicinal substances or materials of animal, microbial or recombinant origin – Guidance on the new regulatory requirements and transition arrangements . ’ MoreCloses 9 October 2024 -
Consultation: Future regulation of assistive technologies
The TGA is seeking feedback on proposed changes to the regulation of assistive technologies. The TGA is Australia's government authority responsible for evaluating, assessing, and monitoring products that are defined as therapeutic goods including medicines, medical devices and biologicals to help Australians stay healthy and safe. T he current provisions in the Therapeutic Goods (Excluded Goods) Determination... MoreCloses 13 October 2024 -
Australian Medical Device Essential Principles - Part 2: Proposed alignment with the European Regulation
The Therapeutic Goods Administration (TGA) is the Australian government authority responsible for the regulation of therapeutic goods including medicines, medical devices, and biologicals. The Australian (AUS) Essential Principles set out the safety and performance characteristics of medical devices in Schedule 1 of the Therapeutic Goods (Medical Devices) Regulations 2002 This consultation This consultation seeks to confirm views, on where appropriate,... MoreCloses 16 October 2024
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