Belgian Approval Process

The application for clinical research authorization should be submitted to the competent authority FAMHP depending on the type of study – medical device research, interventional / observational, pre-market / post market. In addition, all studies must be approved by an accredited Ethics Committee. Both applications can be submitted in parallel. Regarding investigations with a medical device, the FAMHP may approve the study only after the EC grants its authorization.

Clinical trial start-up time: 2-3 months.