Fact Sheets

A guide to De Novo registration

Posted on by Congenius

At Congenius we look to provide reassurance through knowledge. In addition to the services we provide our customers, every six weeks, we will be publishing a fact sheet on a timely MedTech topic. First up, is our quick guide to De Novo Registration. Download the fact sheet below to read about what the De Novo classification process is, when a De Novo registration is required, what you should include in your De Novo request, and guidance on timings and fees involved.

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