CASubmissionFee object
Yes
Fees published for 2015 are provided below as a guide, but should be checked for currency at time of application:
- Active implantable medical devices €3,837.
- Class III and class IIb medical devices €3,837.
- Class IIa and class I medical devices €1,645.
- Technical amendment: €1,129.
- Administrative amendment (e.g., additional investigational site): € 219.
- Resubmission following a withdrawal or objection: €1,500.
No fees are charged for academically sponsored investigations.
(Reduced fee for Resubmission for Academic Sponsor: €500).
The current fees are provided in the “Fee Application Form for Human Products” and the respective “Guide to Fees for Human Products”, being available for download on the HPRA website in section Medical Devices>Regulatory Information> Clinical Investigations.
Fees for applications are laid down in the HPRA (Fees) Regulations, which are made each year by the Minister for Health.