BfArM
The new article describes the approach to be followed by the applicants when presenting sufficient evidence demonstrating the proper performance of their products when used for the intended purpose.
BfArM
The article addresses the aspects related to data protection in the context of digital health applications.
BfArM
The new article provides an overview of the general requirements to be followed when filing submissions associated with digital health applications.
BfArM
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...
BfArM
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...
BfArM
The new article provides a general overview of the key points related to the inclusion of digital health products in the respective register. Table of Contents The German regulating authority, the Federal institute for Drugs and Medical Devices (BfArM) in the sphere...
