Sep 26, 2023
Australia
The new article highlights the aspects related to Class IIb spinal implantable medical devices and also highlights some other points related to the recent changes to the applicable classification rules impacting the regulatory status of spinal implantable medical...
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Sep 22, 2023
Australia
The article provides an overview of the new classification approach adopted in Australia with respect to implantable medical devices. Table of Contents The Therapeutic Goods Administration (TGA), an Australian healthcare product regulatory authority, has...
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Sep 21, 2023
Australia
The new article describes in detail the approach to be applied with respect to the changes to existing entries due to the new classification rules. Table of Contents The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of...
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Sep 20, 2023
Australia
The new article provides a brief overview of the regulatory status of active medical devices by TGA, the regulatory agency of Australia. 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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