1. Application for a certificate
There are three ways to apply for a certificate of free sale :
- Via the webportal
This application can be done via the« free sale certificates » web application available on the web portal. Via the following link, you could find a user manual for the "free sale certificates" application.
- Via email :
Please send the completed form (see below) and attachments to FSC.meddev@fagg-afmps.be. Please structure the subject line as follows : « FSC – company name – country ».
Applications sent by email will be processed electronically. No printing will be done by FAMHP .
- Via post:
Applications sent by post will be processed entirely on paper and will not be converted to electronic format. Documents must be sent by post, in colour and in one copy to:
Federal Agency for Medicines and Health Products
Health Products Division
Avenue Galilée, 5/03
1210 BRUXELLES
2. Forms
Below you will find the different forms for applying for a free sale certificate in paper format. The forms are in English. If you would like a translation into French, Dutch or German, please send an email to FSC.meddev@fagg-afmps.be.
The free sale certificate will only be issued in one of the national language or in English.
- Medical Devices (dir. 93/42/CEE – dir. 90/385/CEE – reg. 2017/745) :
- Manufacturers and authorised representatives: MD Certificate
- Distributors, importers and exporters : MD Certifcate
- In vitro diagnostic medical devices (dir. 98/79/CE – reg. 2017/746) :
- Manufacturers and authorised representatives: IVD Certificate
- Distributors, importers and exporters : IVD Certificate
- Application form for e-legalisation: FR - EN
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The appropriate completed form must be accompanied by documents proving the product's conformity, in this case:
- a declaration of conformity ;
- a copy of the CE certificates (if applicable);
- if relevant, a copy of the manufacturer's ISO 9000 and EN/ISO 13485 certificates.
Find out more in our Q&A.
Please quote the notification number for each medical device when exporting class l medical devices and in vitro diagnostic medical devices (IVD).
Please note that the number of medical devices per certificate of free sale is limited to :
- 10 for medical devices (MD, MDR) and for active implantable medical devices (AIMD). Different sizes of the same medical device, such as L, M, S gloves, are considered as a single device.
- 40 for IVD (IVDD and IVDR). This difference is due to the fact that all IVDs are subject to a notification to the FAMHP for placing on the market.
It is not necessary to indicate the production site(s), or add the corresponding ISO certificates. The manufacturer's ISO certificates are sufficient.
If you wish to specify the production site, please add it in an appendix to the certificate and not on the form.
3. Price
A fee is charged for each certificate. For more information, please visit the FAMHP Fees page .
4. Processing time
The FAMHP Health Products Division will process your file within five weeks if the file is in order.
5. Verification of authenticity
The authenticity of a certificate or document can be verified on request via FSC.meddev@fagg-afmps.be.
6. For more information
If you have any questions about free sale certificates, please contact FSC.meddev@afmps.be
You can also find more information in the document "Questions and answers on certifcate of free sales".