Australia TGA Releases Guidance on Exemption for Certain Clinical Decision Support Software

The Therapeutic Goods Administration (TGA) Australia has released the first version of the guidance document on Exempt Clinical Decision Support …

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Australia TGA Updates Regulation of Software Based Medical Device

The Therapeutic Goods Administration (TGA) Australia has released updates on the regulation of software based medical devices in August 2022. …

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Australia TGA Releases Guidance on Exemption for Clinical Decision Support Software

The Therapeutic Goods Administration (TGA) Australia has released a guidance document on Exempt Clinical Decision Support Software (CDSS) for sponsors, …

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Australia TGA Publishes Latest Clinical Evidence Guidelines for Medical Devices

The Therapeutic Goods Administration (TGA) Australia has released the latest guidelines on clinical evidence requirements for medical devices, including in …

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Australia TGA Issues Factsheet on Software-Based Medical Devices in Digital Mental Health

The Therapeutic Goods Administration (TGA) Australia has released a factsheet on software based medical devices in digital mental health in …

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Australia TGA Publishes Latest Guidance on Medical Device Patient Information Leaflets and Implant Cards

The Therapeutic Goods Administration (TGA) Australia has published the latest version of the guidance document on patient information materials (patient …

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Australia TGA Publishes Information on Manufacture of Medical Devices

The Therapeutic Goods Administration (TGA) Australia has published some information regarding the manufacture of medical devices pertaining to quality management …

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Australia TGA Publishes Latest Guidance on Reclassification of Active Implantable Medical Devices

The Therapeutic Goods Administration (TGA) Australia has published the latest document on the reclassification of active implantable medical devices (AIMD) …

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Australia TGA Publishes Information on Regulation Essentials

The Therapeutic Goods Administration (TGA) Australia has published a general overview of the regulatory process, along with information about relevant …

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