CASubmissionOfApplication object

Responsible for study submission


Prerequisites for submission

Positive opinion by relevant EC(s)

Guidance on submission of application

The application documentation is specified in Art 44(3) Medical Device Act of 2010 (en).

Applicable national legal framework/ Reference

Art 44 of the Act on Medical Devices of 20 May 2010 (en)/ Dz.U. 2010, No 107, Item 679 (pl)

Additional Information

NB! A positive opinion of the competent EC is a prerequisite for application to the CA, as this is an integral part of the submission