Certificate of Free Sales (CFS)
for Medical Devices
What is a Certificate of Free Sale (CFS)?
Many Ministries of Health and other regulators around the world require foreign manufacturers to provide a Certificate of Free Sale (CFS) or Export Certificates or Free Sale Certificates; name depends on the issuing authority. Such a certificate will show that the products are approved for sale in the EU.
A CFS is a certificate issued for export of any other item which is not restricted or prohibited for export confirming that the product is freely sold in the EU without any indication that the product is evaluated for safety and efficacy and is registered for use in the EU.
It gives an assurance from a foreign agency that the products listed on the certificate are freely sold and manufactured in the country seeking to export a particular item.
Who can get an CFS?
CFS will be prepared for Manufacturers and Authorized Representatives of medical devices. CFS are issued for products which are exported outside of the EU and to countries without a mutual recognition agreement with the EU.
European CFS are issued for medical devices which are CE-marked according to the Medical Devices Regulation (MDR) (EU) 2017/745 and In Vitro Diagnostic Medical Devices Regulation (IVDR) (EU) 2017/746.
BZT-AR as an Authorized Representative in Germany can apply CFS documents from the German Federal Office for Economic Affairs and Export Control on behalf of the manufacturer.
Which countries request an CFS?
CFS must present to authorities as part of the registration process in the countries below:
United Arab Emirates
How to proceed Applications?
The product must be fully conformed with the related European Directives, Regulations and Standards, e.g. testing and certifications, DOC etc..
A non-EU manufacturer must hold a Mandate with a European Authorized Representative. Only a European Authorized Representative or a European Responsible Person can obtain for an CFS on behalf of a non-EU manufacturer.
BZT-AR as an Authorized Representative in Germany can procure the CFS applications on behalf of a non-EU manufacturer.