Certificate of Free Sale
Certificate of Free Sale according to the Regulation (EU) 2017/745 is issued for the purpose of export and upon request by a manufacturer or an authorized representative, in which the Member State declares that the manufacturer or authorized representative has its registered place of business on its territory and that the device in question bearing the CE marking may be marketed in the Union.
In the Republic of Poland, Certificate of Free Sale is issued by the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL).
This document makes the process of exporting medical devices (MD), In Vitro Medical Devices (IVD MD) and active implantable medical devices to other countries easier.
It can be issued for the CE marked device or custom-made device.
To be able to receive it, it is necessary to:
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Be either manufacturer or authorised representative and
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Reside in Poland or have registered place of business in Poland.
Certificate of Free Sale is a confirmation that the medical device is CE-marked product and that it can be placed on the market or put into service on the territory of Poland and that it can be exported.
Certificate of Free Sale can be issued for the medical device that has been registered with the Office URPL at least 14 days before.
The Certificate of Free Sale will be issued in 15 days since the application date in two languages: Polish and English.
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