How can a DiGA manufacturer prepare the upcoming application process?

During the DiGA Summit, the federal ministry of health (BMG), the federal institute for pharmaceuticals and medical devices (BfArM) as well as the health innovation hub (hih) announced that the application process for digital health applications (DiGAs) will expectedly start as of May. For the official start, especially the digital application portal by BfArM is necessary for the submission of the applications.

Even if the portal is not yet live and therefore no submission of applications is possible, the application can be prepared and initiated by the following steps:

1. Contacting BfArM’s Innovation Office and apply for a kick-off meeting

The BfArM offers advise for manufacturers (with costs) which is typically conducted during a kick-off meeting. During this meeting, a manufacturer can discuss questions regarding the prerequisites for a DiGA by BfArM. By clarifying these questions, the pathway to a positive decision on the inclusion into the DiGA catalogue can be paved.

2. Screening and preparing checklists and application documents

The checklists of the annexes 1 and 2 of the DiGA regulation (DiGAV) must be answered with “applicable”. The further application documents will be available in BfArM’s web portal in German and English.

3. Planning the preliminary or final inclusion into the DiGA catalogue

You can only apply for final inclusion of the application into the DiGA catalogue if at least one positive supply effect can be proven by a manufacturer’s study. If this is not (yet) possible, a preliminary inclusion can be requested. This allows manufacturers to deliver the proof of a positive supply effect later (within 12 months).

In any case a structured planning and preparation on the manufacturer’s side is necessary for a DiGA application. If BfArM decides that the application will not be included into the DiGA catalogue (due to missing documents or other), the manufacturer can only submit a new application after 12 months.

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