Pursuant to Section 94, paragraph 2, of the Act on Medical Devices, the person handling medical devices shall be obliged to cover the costs of Institute’s services.
| Notification of operation of a sponsor of a clinical investigation on a medical device | 2 500 CZK |
| Application for medical device clinical investigation authorisation | 500 CZK |
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.
|
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 |
Clinical Evaluation of Medical Devices Department
1. 7. 2015
cz