Jun 12, 2023
Australia and Oceania
The article provides an overview of the existing regulatory framework for software-based medical devices. Table of Contents The Therapeutic Goods Administration (TGA), an Australian regulating authority in healthcare products, has published guidelines on the...
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Feb 7, 2023
Australia and Oceania
The new article provides an overview of the recent changes to the classification rules for certain medical devices. Table of Contents The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has published a...
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Jan 27, 2023
Australia and Oceania
The article provides an overview of the new classification rules to be applied. Table of Contents The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has published a set of guidance documents dedicated...
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Jan 27, 2023
Australia and Oceania
The new article describes in detail the approach to be applied by the parties responsible for medical devices when notifying the authority about the products subject to reclassification they are going to supply. Table of Contents The Therapeutic Goods Administration...
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Jan 27, 2023
Australia and Oceania
The new article provides an overview of the recent changes to the classification rules for active implantable medical devices. Table of Contents The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has...
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