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.
Australia
The article briefly overviews the processes and procedures associated with applying for conformity assessment certification.
Australia
The article highlights the critical points related to the regulatory status of certain software products.
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.
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.
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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