BfArM Guidance on Fast-Track Process for Digital Health Applications: Timeframes
The new article highlights the aspects related to the timeframes the applicants should follow.
The new article highlights the aspects related to the timeframes the applicants should follow.
The new article outlines specific requirements to be considered depending on the study type or design.
The new article describes in detail the approach to be applied with respect to applications for advertisement approval to be submitted by interested parties.
The new article highlights the aspects related to monitoring methods and associated matters.
The new article highlights the aspects related to the process of applying for a medical device establishment license required to conduct operations with medical devices.
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