Actualités sur les essais cliniques de dispositifs médicaux et études des performances concernant les dispositifs médicaux de diagnostic in vitro


Clinical investigations and performance studies: Fee for the simplified review of clinical trials

Under certain circumstances, sponsors can apply for a simplified review of their authorisation application. A flat fee of CHF 1500.- is applicable since 01.01.2023  (GebV-Swissmedic ; 812.214.5). The flat fee for a regular review of CHF 5000.- remains unchanged. Additional information concerning fees and concerning simplified review are available in the Swissmedic information sheet BW600_00_015e_MB (for clinical investigations of medical devices) and BW600_00_016e_MB (for interventional performance studies of IVD).