Medical device operator: Check the information in the register, for the supervision fee to be collected in 2023
In accordance with section 50 of the Medical Devices Act (719/2021), Fimea collects an annual supervision fee from the medical device operators, subject to the reporting obligation, in its register. The supervision fee is charged from each of the registered roles separately. For example, if you act as a distributor and manufacturer, you will receive an invoice with two supervision fees.
Operators are obliged to notify Fimea of any relevant changes in the information they have provided. The supervision fee for the following year will be determined based on the information reported by the end of 2022. Therefore, we remind operators to check the information in the registers before the turn of the year.