CASubmissionFee object
Yes
Notification of operation of a sponsor of a clinical investigation on a medical device: 2 500 CZK
Application for medical device clinical investigation authorization: 500 CZK
Expert activities associated with the issue of authorisation of conduct of a clinical investigation on a medical device: 15 000 CZK
Expert activities associated with the issue of authorisation of changes to the conditions of a clinical investigation
on a medical device: 1 500 CZK
If the sponsor is non commercial subject and ask the SUKL for a fee waiver, it is possible to get the assessment for free.
Yes
The amount of costs of expert services is set forth by an implementing legal regulation, Decree No 61/2015 Coll., on determination of the amount of reimbursement for expert activities conducted by the State Institute for Drug Control pursuant to the Act on Medical Devices, of 31 March 2015.
Fees are also specified on SUKL website in section: Medical Devices / Clinical evaluation of medical devices / Fees associated with clinical investigation authorization.
