Aug 14, 2023
Australia and Oceania
The new article addresses aspects related to the documentation to be provided by the interested party responsible for the medical device in question and also describes the way the fees associated with the application audit should be calculated. Table of Contents The...
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Aug 14, 2023
Australia and Oceania
The new article provides an overview of the applicable regulatory procedures and requirements. Table of Contents The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has published a guidance document...
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Jun 19, 2023
Australia and Oceania
The new article provides a brief overview of the regulatory approach towards software-based products intended to be marketed and used in Australia. Table of Contents The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of...
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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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