CASubmissionOfApplication object

Responsible for study submission

Manufacturer
Legal representative domiciled in the EU/EEA

Prerequisites for submission

Positive opinion by relevant EC(s)

Guidance on submission of application available

Yes

Guidance on submission of application

Ordinul ministrului sanatatii nr. 792/2006 privind desfăşurarea procedurii de investigaţie clinică şi a procedurii de evaluare a performanţei pentru dispozitivele medicale

National legal framework in place

Yes

Applicable national legal framework/ Reference

Ordinul ministrului sanatatii nr. 792/2006 privind desfăşurarea procedurii de investigaţie clinică şi a procedurii de evaluare a performanţei pentru dispozitivele medicale

Standardul SR EN ISO 14155/2012 Investigaţia clinică a dispozitivelor medicale pentru subiecţi umani. Bună practică clinică – se procura contracost de la ASRO (www.asro.ro), numar de catalog 1412

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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