CASubmissionFee object

Fees for trial submission mandatory

Yes

Fees

• Authorization of MD studies: € 824.24 - (Cat II-III)
• Authorization of combined (MD+MP) studies: € 824.24 + €1508.22 for the evaluation of the active substance incorporated into the MD (Cat IV-VI)

Waiver for academic (non-commercial) studies possible

No

Official guidance on required fees available

Yes

Official guidance on required fees

The current fees (Tasas del Grupo VIII) and payment modalities (Instrucciones para el pago de las tasks por residentes/ no residentes en España) are provided on the AEMPS website in section Clinical research with Medical Devices>Tasas/Fees

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395
Feedback