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.
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 additional details pertaining to the submission template to be used by the parties interested in applying for marketing permission for medical devices utilizing innovative technologies.
FDA
The new article provides further clarifications regarding requests for information as provided under the existing legal framework.
Australia
The new article provides additional clarifications pertaining to specific regulatory matters associated with in-house manufactured in vitro diagnostic medical devices, including, inter alia, responsibilities of the parties involved, as well as exclusions set forth under the existing legal framework.
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