BfArM Guidance on Fast-Track Process for Digital Health Applications: Specific Requirements for Study Types
The new article outlines specific requirements to be considered depending on the study type or design.
The new article outlines specific requirements to be considered depending on the study type or design.
The new article highlights the key points related to the studies to be carried out to demonstrate a positive supply effect.
The document describes in detail the aspects related to the statement of positive care effect to be included in the submission.
The new article highlights the aspects related to the temporary and permanent admission of digital health applications. Table of Contents The German regulating authority in the sphere of healthcare products, the Federal Institute for Drugs and Medical Devices...
The new article addresses the aspects related to the directory containing information about any and all digital health applications available in Germany. Table of Contents The German regulating authority in the sphere of healthcare products (BfArM) has published a...
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