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 26, 2024
Australia
The new article describes in detail the applicable types and classes of recalls and also explains the difference between recalls and non-recall actions from a regulatory standpoint.
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Apr 12, 2024
EU
The article provides a general overview of the approach to be followed when creating a clinical investigation plan for medical devices.
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Apr 8, 2024
FDA
The new article provides additional details regarding specific aspects associated with cyber devices, such as modifications to it.
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Mar 6, 2024
Australia
The article provides an overview of the legal framework for labeling requirements applicable to medical devices intended to be marketed and used in Australia.
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