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.
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.
The article highlights the key points associated with notifications for certain types of medical devices in the context of their specific regulatory nature.
The new article provides additional clarifications regarding the regulatory approach to be followed with respect to the tools intended to be used for the digitalization of paper-based records used in the healthcare sphere.
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