Apply for inclusion of a digital health application (DiGA) in the DiGA directory

Procedure

The entire application procedure is carried out exclusively electronically via the BfArM application portal. The link can be found on the BfArM website.

• In order to submit an application for inclusion of a DiGA in the directory, you must register.
• To do this, you must create a user account (for initial registration). The following steps are necessary for this:
  
  • Registration in the portal with a valid e-mail address, the use of a functional e-mail address is recommended for data protection reasons.
  • Confirm the e-mail address via a link in the mailbox and
  • Set a password.
• For the submission of applications and notifications: Extended Validation (EV) certificate must be available and the public part of the certificate must be uploaded to the portal.

After successful registration, you can create one or more DiGAs in the application portal and complete and submit the following online forms for applications and notifications for each DiGA - depending on the issue:

• Application for inclusion in the DiGA directory
• Application for extension of the trial
• Submission of evidence for final inclusion in the DiGA directory after testing
• Notification of significant changes
• Application for removal from the directory

The application procedure begins when you have submitted the complete application for inclusion of a DiGA in the DiGA directory to the BfArM.

• Once the application procedure has begun, the BfArM first carries out an incoming goods inspection to check the formal completeness of the documents and evidence submitted.
• If the documents and evidence are complete, the BfArM will confirm receipt of the application documents within 14 days, stating the date of receipt as the start of the processing period.
  Otherwise, you will receive a letter with a list of the information and documents that still need to be corrected or submitted.
• At the heart of the procedure are the
  
  • checking the manufacturer's information on the required product properties
  • as well as the examination of proof to be provided by the manufacturer of the positive supply effects that can be realized with the DiGA.
• Upon receipt of a positive decision on the inclusion of a DiGA in the list, it will be published there.

Legal bases

• § 33a Sozialgesetzbuch (SGB) Fünftes Buch (V)
• §139e Sozialgesetzbuch (SGB) Fünftes Buch (V)
• Verordnung über das Verfahren und die Anforderungen zur Prüfung der Erstattungsfähigkeit digitaler Gesundheitsanwendungen in der gesetzlichen Krankenversicherung (Digitale Gesundheitsanwendungen-Verordnung - DiGAV)
• Gesetz zur Beschleunigung der Digitalisierung des Gesundheitswesens (Digital-Gesetz – DigiG)

More information

The BfArM charges fees for the processing of applications and notifications (inclusion of DiGA in the DiGA directory, notification of significant changes). Details can be found under Fees/Costs and related publications.

Appeal: Detailed information on how to lodge an appeal can be found in the notification of your application.