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 overviews the legal framework for medical device systems and procedure packs intended to be marketed and used in Australia.
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.
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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