Australia
The final article of the cycle clarifies certain specific regulatory matters associated with submissions, such as the applicability of transitional provisions or modifications to submissions and the way they should be introduced.
Australia
The new article further describes in detail the specific approach to be followed when making a submission, highlighting the key points to be considered by the parties involved.
FDA
The final article of the cycle provides additional clarifications regarding certain specific aspects associated with the use of electronic records in the context of clinical investigations.
FDA
The new article provides further clarifications regarding the clinical follow-up and supervision to be conducted by the parties responsible for clinical investigations.
Australia
The article highlights the key points associated with notifications for certain types of medical devices in the context of their specific regulatory nature.
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