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

What deadlines must be paid attention to?

If the BfArM determines during the review that the application documents are incomplete, it will ask you to complete the application within a period of up to 3 months and submit the changes or additions via the application portal.

How long does it take to process

After receipt of the complete application. In justified individual cases, the deadline can be extended by up to a further three months.

What are the costs?

1.500,00 EUR bis 9.000,00 EUR Decision on inclusion in the list
300,00 EUR bis 4.900,00 EUR Change notices
1.500,00 EUR bis 4.900,00 EUR Application for extension of the trial
1.500,00 EUR bis 6.600,00 EUR Submission of evidence for final inclusion in the DiGA directory
200,00 EUR Deletion from the list