An online request for a Free Sales Certificate (FSC) needs to be accompanied by the following information:

Medical devices

  • the name(s) of the medical device(s) concerned. If a medical device class I is concerned, the device has to be registered at the CIBG. If you have not yet applied at the CIBG, this still should be done. If devices class IIa, IIb and III are concerned, the related CE-certificates (issued by a Notified Body) have to be enclosed.
  • the country/countries of destination (each country requires a separate FSC) and, if applicable, specific demands of the country concerned.
  • the number of copies per country`.

In vitro diagnostics

  • the name(s) of the IVDs concerned. For IVDs of a higher risk class (class A, class B, self-tests) the related CE-certificates (issued by a Notified Body) have to be enclosed. For all other IVDs please include the original registration form.
  • the country/countries of destination (each country requires a separate FSC) and, if applicable, specific demands of the country concerned.
  • the number of copies per country.

Login with eHerkenning

For the Farmatec online service you need to purchase eHerkenning level EH2+. eHerkenning is provided by 6 accredited suppliers.
On the eHerkenning website you will find a step-by-step plan that will help you on your way to requesting a login tool.

At www.eherkenning.nl you'll find more general information in English.

Do you already have an eHerkenning login? Go directly to Login

Procedure

If the application contains all information (including required documents), we strive to send you a FSC within 4 weeks from the date of application. If anything in the request(s) remains unclear the CIBG will contact the applicant by phone or e-mail.

Fee

The CIBG charges the applicant € 62,-- per FSC. Per invoice € 62,-- administration fee is required. For payment, an invoice and payment-slip will be sent in the quarter after receipt of the statement.