Sep 18, 2023
Australia
The new article highlights the aspects related to the review procedures, and emphasizes the involvement of the administrative tribunal. Table of Contents The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare...
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Sep 14, 2023
Australia
The new article addresses aspects related to the submission of the request for reconsideration and its subsequent review by the Minister. Table of Contents The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare...
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Aug 16, 2023
Australia and Oceania
The article describes the approach to be applied when requesting that a regulatory decision be reconsidered. Table of Contents The Therapeutic Goods Administration (TGA or the Agency), the Australian regulating authority in the sphere of healthcare products, has...
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Aug 16, 2023
Australia and Oceania
The new article highlights aspects related to the application review process and regulatory decisions the authority will make based on its assessment. Table of Contents The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of...
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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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