ECSubmissionOfApplication object

Responsible for study submission

Sponsor

Guidance on study submission

The required documentation accompanying the application is set forth by Section 21(a) except for items 5 and 6 of the Act on Medical Devices

Applicable national legal framework/ Reference

Section 17 & 21 (a) of Act No 268/2014 on Medical Device

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395
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