Certificates of Free Sale to Danish manufacturers of medical devices
The Danish Medicines Agency issues Certificates of Free Sale free of charge to manufacturers of medical devices who are headquartered in Denmark and have registered with the Danish Medicines Agency.
A Certificate of Free Sale is issued for products which are to be exported to countries outside the European Economical Area (EEA) and countries without a mutual recognition agreement (MRA).
The Certificate of Free Sale is not an authorisation of the products listed on the certificate.
The certificates are valid for two years, unless certificates from the notified body are valid for a shorter period.
How do I apply for a Certificate of Free Sale?
Find the correct template in the below table. Right-click ”Download", and select ”Save destination as”, and save the template on your PC.
Fill in the template; your address on page 1 and products on page 2, use Arial. Send your application to email@example.com, and state the requested number of Certificates of Free Sale and the name and address of the person the certificates should be sent to.
Attach the completed template and the required documentation: declaration of conformity and certificates from the notified body.We aim to issue the Certificates of Free Sale within ten days provided that the application is complete. If the application is insufficient, we will contact you.
Make sure that the product names listed on the Certificates of Free Sale are the same as on the related declarations of conformity and the certificates from the notified body. State the exact product names/product specifications listed on the declaration of conformity.
Regarding CE marked devices, enclose a copy of the applicable declarations of conformity for the products listed on the Certificate of Free Sale.
Regarding system and medical treatment packages, enclose a copy of the declaration covering compatibility as described in the applicable executive order.
Regarding devices covered by a certificate from a notified body, enclose copies of the relevant and valid certificates, for example Annex II certificate (full quality assurance), Annex V certificate (production quality assurance) and the design examination certificate.
Regarding non-CE marked devices, i.e. devices exclusively marketed outside the EU and EEA, no documentation needs to be enclosed.
If you have previously obtained Certificates of Free Sale for the same products, you do not have to attach the documentation again. However, you should state a clear reference to the documentation that you submitted previously (date of your e-mail, e-mail sender, file name and document numbers), and the documentation must still be valid.
Always submit a template
Every time you apply for Certificates of Free Sale, you must submit a filled-in template. If you have previously obtained Certificates of Free Sale for the same products, you can reuse the same template, e.g. after having updated the product list.
If you need Certificates of Free Sale for a number of products governed by more than one executive order, you have to submit a filled-in template per executive order. The same applies to various language versions.
If you want to export medical devices, you can find advice and guidance on the website of the Ministry of Foreign Affairs of Denmark or contact your industry association.
Please note that individual countries may have special rules in this area.