February 2, 2026
Approximately 5 minutes
Reviewed by Nate Lam, Founder & Director, ElendiLabs
FAMHP Process for Issuing Certificates of Free Sale for Medical Devices in Belgium
1. Overview and Recent Changes
Since 1 February 2025, applications for Certificates of Free Sale (FSCs) are submitted exclusively by email to FSC.meddev@fagg-afmps.be. Certificates are issued electronically only; no paper versions are provided. The email subject must follow the format: « FSC – company name – country ». Source: FAMHP Certificates Application Procedure https://www.famhp.be/en/human_use/health_products/medical_devices_accessories/certificates/certificates_application_procedure
2. Fee Structure
For 2026, the fee is €283.66 per certificate. Source: FAMHP Certificates Application Procedure https://www.famhp.be/en/human_use/health_products/medical_devices_accessories/certificates/certificates_application_procedure
3. Application Forms
Bilingual forms (FR/EN, NL/EN, DE/EN) are provided based on applicant type (authorised representative/manufacturer or distributor/importer/exporter), device type (medical devices or IVDs), and applicable regulation (MDR/IVDR or MDD/IVDD). Source: FAMHP Certificates Application Procedure https://www.famhp.be/en/human_use/health_products/medical_devices_accessories/certificates/certificates_application_procedure
4. Device Limits per Certificate
- Maximum 10 medical devices (including AIMD) per certificate; different sizes of the same device count as one.
- Maximum 40 IVDs per certificate. Production sites need not be specified, and manufacturer ISO certificates are sufficient. Source: FAMHP Certificates Application Procedure https://www.famhp.be/en/human_use/health_products/medical_devices_accessories/certificates/certificates_application_procedure
5. Required Supporting Documents
Mandatory attachments include:
- Completed application form.
- Declaration of conformity.
- CE certificate(s) if applicable.
- Manufacturer's ISO 9000 and EN/ISO 13485 certificates if relevant.
For transitional (legacy) devices under MDD/AIMD or IVDD:
- Specific manufacturer's declaration forms.
- Proof of written agreement with notified body or formal application, with phased mandatory requirements. Source: FAMHP Certificates Application Procedure https://www.famhp.be/en/human_use/health_products/medical_devices_accessories/certificates/certificates_application_procedure
6. Processing Timeline
Complete applications are processed within five weeks. Source: FAMHP Certificates Application Procedure https://www.famhp.be/en/human_use/health_products/medical_devices_accessories/certificates/certificates_application_procedure
7. Verification and Contact
Certificate authenticity can be verified via FSC.meddev@fagg-afmps.be. Use the same email for inquiries. Source: FAMHP Certificates Application Procedure https://www.famhp.be/en/human_use/health_products/medical_devices_accessories/certificates/certificates_application_procedure
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Registered Pharmacist · AI Engineer · Director, ElendiLabs
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