CASubmissionFee object

Fees for trial submission mandatory

Yes

Fees

Fees for authorization:
1) Clinical investigation: 5000 PLN (approx. € 1200.- )
(In general terms described as up to seven minimum remuneration for work for the fee for starting a study according to Art 44 (2.1) Medical Device Act 2010)
2) Amendments: 1500 PLN (approx. € 350.-)
(In general terms described as up to half of the amount charged for authorization of a clinical investigation according to Art 44 (2.2) Medical Device Act 2010

Non-commercial trials: No waiver or reduced fee are granted (as opposed to IMP trials - there is no analogy between medicinal products' law and medical device in that matter in Poland)

Waiver for academic (non-commercial) studies possible

No

Official guidance on required fees

Fees are specified in the Order of the Minister of Health 15 Nov 2010/ Dz.U. 2010 nr 222 poz. 1453

Applicable national legal framework/ Reference

Order of the Minister of Health 15 Nov 2010/ Dz.U. 2010 nr 222 poz. 1453
Medical Device Act 2010 (en)/ Dz.U. 2010 nr 107 poz. 679 (pl)

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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