Apr 26, 2024
Australia
The new article provides additional details regarding the subsequent steps of the recall process, including the development of an action strategy, drafting a communication strategy to be followed when conducting a recall, and also the matters related to interactions with the authority, such as the noes associated with the submission of the relevant notification and an assessment to be conducted by the TGA
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Apr 12, 2024
Australia
The article briefly overviews the processes and procedures associated with applying for conformity assessment certification.
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Apr 8, 2024
Australia
The article highlights the critical points related to the regulatory status of certain software products.
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Apr 8, 2024
Australia
The new article provides an in-depth overview of the problems identified and solutions proposed by the authority, together with the questions to be answered by the key stakeholders.
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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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