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February 4, 2026
Approximately 5 minutes
Application Procedure for Free Sales Certificates in Belgium
Application Procedure for Free Sales Certificates in Belgium
1. Key Changes and Submission Method
Since 1 February 2025, FSC applications are submitted exclusively by email to FSC.meddev@fagg-afmps.be. No paper versions are issued. Structure the email subject as: « FSC – company name – country ». Applications are processed electronically. Source: FAMHP Free Sales Certificates Application Procedure https://www.famhp.be/en/human_use/health_products/medical_devices_accessories/certificates/certificates_application_procedure
2. Fee
In 2026, the fee is €283.66 per certificate. Source: FAMHP Free Sales 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 available depending on activity (authorised representative/manufacturer or distributor/importer/exporter), device type (medical devices or IVDs), and regulation (MDR/IVDR or MDD/IVDD). Source: FAMHP Free Sales 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. No need to specify production sites or attach site-specific ISO certificates; manufacturer's ISO certificates suffice. Source: FAMHP Free Sales Certificates Application Procedure https://www.famhp.be/en/human_use/health_products/medical_devices_accessories/certificates/certificates_application_procedure
5. Required Supporting Documents
Applications must include:
- Completed form
- Declaration of conformity
- Copy of 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 submission, with phased mandatory dates Source: FAMHP Free Sales Certificates Application Procedure https://www.famhp.be/en/human_use/health_products/medical_devices_accessories/certificates/certificates_application_procedure
6. Processing Time
Complete dossiers are processed within five weeks. Source: FAMHP Free Sales Certificates Application Procedure https://www.famhp.be/en/human_use/health_products/medical_devices_accessories/certificates/certificates_application_procedure
7. Authenticity Verification and Contact
Certificate authenticity can be verified upon request via FSC.meddev@fagg-afmps.be. For questions, contact the same email. Source: FAMHP Free Sales Certificates Application Procedure https://www.famhp.be/en/human_use/health_products/medical_devices_accessories/certificates/certificates_application_procedure
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