Academic trials: Application for fee reduction for clinical trials with medical devices (clinical investigations and performance studies)


Which trials are concerned?

Various types of trials involving human subjects need to be authorised by Swissmedic. An 80% reduction in the flat-rate fees for authorisation procedures is available for certain academic clinical trials; applications for this fee reduction can be submitted with immediate effect.

In order to qualify for a fee reduction, the responsible sponsor must confirm that no commercial third-party funds are being used to carry out all or part of the clinical trial. For other types of funding – e.g. from universities, foundations, the Swiss National Science Foundation or Innosuisse – a fee reduction is possible.

How do I submit an application for fee reduction for a clinical investigation or a performance study?

Submit your application, which consists of the two documents BW610_10_029e_FO_Application_fee_reduction and BW610_10_030e_VL_Application_fee_reduction_selfdeclaration together with your next authorisation application. Place both documents in the ‘00.00_Swissmedic_forms’ folder of your eDok submission. If required, an introduction to eDoks and electronic submissions can be found in Annex A6 of Information Sheet BW600_00_015e_MB or of Information Sheet BW600_00_016e_MB.

Please note: If you receive commercial third-party funding during the course of the trial, you must inform us in the cover letter when you next submit an application.