Free sales certificates

Application

A request for an FSC needs to be accompanied by the following information:

Medical devices (Directive 93/42/EEC and 90/385/EEC):

  • 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 (Directive 98/79/EC):

  • the name(s) of the IVD’s concerned. For IVD’s 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 IVD’s 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.

Please send your application for FSCs (including the required documents) to:

CIBG
Farmatec-BMC
PO Box 16114
2500 BC The Hague
The Netherlands

The application can also be sent by email to: medische_hulpmiddelen@minvws.nl

Procedure

If the application contains all information (including required documents), we strive to send you a FSC within 2 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.

The CIBG returns the FSC to the applicant as soon as it has been stamped and signed.

After receiving the FSC it can be forwarded for legalization to the Ministry of Foreign Affairs, Chamber of Commerce and/or Embassy.

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.

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