Australia
The article highlights the key points related to the regulatory framework for conformity assessment bodies designated to undertake the relevant procedures in Australia.
ARTG
The article highlights the key points related to the regulatory requirements for in vitro diagnostic (IVD) medical devices manufactured by healthcare institutions to address their internal needs.
ARTG
The new article describes in detail the applicable classification rules in-house in vitro diagnostic medical devices are subject to, as well as the relevant regulatory requirements to be applied depending on the classification.
Australia
The new article provides an overview of the regulatory procedures associated with the changes to sponsorship in the context of 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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