The Radiation and Nuclear Safety Authority
In accordance with the Radiation Act, the use of radiation requires a safety license issued by The Radiation and Nuclear Safety Authority (STUK), unless the practice is specifically exempted. Instructions for applying safety license are available at STUK website. The license should be valid before commencing the clinical trial with a clinical investigational medical device/drug involving radiation/radioactive material. The Medical Devices Act also contains regulations concerning clinical trials with medical devices emitting radiation or with radioactive material. Submission of trial notification to Finnish Medicines Agency (Fimea) is needed if the clinical trial includes radioactive material, e.g. diagnostic product.
The processing fees charged for a safety licence vary regarding the Class:
- 576 € for Class I
- 864 € for Class II
- 1326 € for Class III