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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Mar 6, 2024
Australia
The article overviews the legal framework for medical device systems and procedure packs intended to be marketed and used in Australia.
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Mar 6, 2024
Australia
The new article describes in detail the key points related to the regulatory requirements applicable to the specific groups of products, namely medical systems and procedure packs.
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Mar 6, 2024
Australia
The new article clarifies the particular conformity assessment procedure to be applied in the context of medical device systems and procedure packs.
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