1. Application for a certificate
There are two ways to apply for a certificate of free sale :
- 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 .
2. Via post: Important! From February 1, 2025, requests will be made by email only. There will be no more “paper versions” issued for FSCs.
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
These forms are bilingual (choose: FR/EN, NL/EN, DE/EN). Different forms are available, depending on your activity, the applicable legislation and the type of device for which you are making the request.
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Important! From February 1, 2025, requests will be made by email only. There will be no more “paper versions” issued for FSCs.
|
Activity |
Type of devices |
Applicable regulations |
Forms for request by email (electronic version) |
Forms for requests by postal mail (paper version) |
|
Authorized representative or manufacturer |
Medical devices |
MDR (regulation 2017/745) |
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|
MDD (directive 93/42/CE) |
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|
In vitro diagnostic devices |
IVDR (regulation 2017/746) |
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|
IVDD (directive 98/79/CE) |
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|
Distributor, importer or exporter |
Medical devices |
MDD/MDR |
||
|
In vitro diagnostic devices |
IVDD/IVDR |
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3. Number of devices per request.
Please note that the number of medical devices per certificate of free sale is limited to :
- 10 for medical devices (MDD, MDR) and for active implantable medical devices (AIMD). Different sizes of the same medical device, such as S, M, L gloves, are considered as a single device.
- 40 for IVDs (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.
4. Required documents
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.
For medical devices covered by Directive 93/42/EEC or 90/385/EEC, benefiting from a transition period according to Article 120 of Regulation 2017/745:
• the manufacturer's declaration form;
• the proof of the signing of a written agreement with a notified body for conformity assessment in accordance with Regulation 2017/745.
For in vitro diagnostic devices (IVDs) covered by Directive 98/79/EC (IVDD) benefiting from a transition period according to Article 110 of Regulation 2017/746 (IVDR):
• the manufacturer's declaration form;
• the proof of the submission of a formal conformity assessment application in accordance with Regulation 2017/746 if applicable.It is mandatory from:
- May 26, 2025 for IVDs covered by an IVDD certificate (IVD on List A or B of Annex II of the IVDD, IVDs for self-testing under the IVDD) and for “others” IVDs under the IVDD (not covered by an IVDD certificate) that are class D under the IVDR;
- May 26, 2026 for “others” IVDs under the IVDD (not covered by an IVDD certificate) that are class C under the IVDR;
- May 26, 2027 for “others” IVDs under the IVDD (not covered by an IVDD certificate) that are class B and A sterile under the IVDR.
• the proof of the signing of a written agreement with a notified body for conformity assessment in accordance with Regulation 2017/746 if applicable.It is mandatory from:
- September 26, 2025 for IVDs covered by an IVDD certificate (IVD on List A or B of Annex II of the IVDD, IVDs for self-testing under the IVDD) and for “others” IVDs under the IVDD (not covered by an IVDD certificate) that are class D under the IVDR;
- September 26, 2026 for “others” IVDs under the IVDD (not covered by an IVDD certificate) that are class C under the IVDR;
- September 26, 2027 for “others” IVDs under the IVDD (not covered by an IVDD certificate) that are class B and A sterile under the IVDR.
Find out more in our Q&A.
Please note that these documents must be in the possession of the FAMHP if applicable on the day the FSC is issued. So don't hesitate to send them even if they are not yet mandatory on the day you send your application
5. Price
A fee is charged for each certificate. For more information, please visit the FAMHP Fees page .
6. Processing time
The FAMHP Health Products Division processes your dossier within five weeks for requests by email and eight weeks for requests by post if the file is in order.
7. Verification of authenticity
The authenticity of a certificate or document can be verified on request via FSC.meddev@fagg-afmps.be.
8. 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".