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February 2, 2026
Approximately 5 minutes
FAMHP Process for Issuing Certificates of Free Sale for Medical Devices in Belgium
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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