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
Canada
The new article describes in detail the authority’s review process when assessing applications related to medical devices.
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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
FDA
The article provides an overview of the regulatory approach to be applied concerning certain regulatory matters.
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Apr 1, 2024
Canada
The article highlights the critical points of managing new submissions related to the products intended to be placed on the Canadian market.
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