Apply for inclusion of a digital health application (DiGA) in the DiGA directory
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Register und Kataster
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Anlagen, Waren und Stoffe
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?
Decision on inclusion in the list
Fee: 1,500 - 9,000 EUR
Change notices
Fee: 300.00 - 4,900 EUR
Application for extension of the trial
Fee: 1,500 - 4,900 EUR
Submission of evidence for final inclusion in the DiGA directory
Fee: 1,500 - 6,600 EUR
Deletion from the list
Fee: EUR 200.00