Want real case studies? 10 seconds to sign up
Join the platform
February 4, 2026
Approximately 5 minutes
Reviewed by Nate Lam, Founder & Director, ElendiLabs
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
Need Regulatory Help? Try Our Platform
Post your regulatory questions or request quotations from verified pharmaceutical consultants worldwide. Get matched with experts who specialize in your market.
Registered Pharmacist · AI Engineer · Director, ElendiLabs
Registered pharmacist, AI engineer, HKHAIS founder, and pharmaceutical & medical device SEO/GEO specialist.
Ask Anything
We'll follow up with you personally.
100% response rate • Reply within 7 business days
Related Articles
Approximately 5 minutes
Regulatory Requirements for Class I Medical Device Manufacturers in Belgium
Manufacturers of Class I medical devices in Belgium must fully comply with the MDR (EU) 2017/745, register in Eudamed, notify FAMHP during the transition period until May 2026, issue an EU Declaration of Conformity, maintain technical documentation, and fulfil post-market surveillance obligations, with specific rules for sterile, measuring, and reusable surgical subcategories.
Approximately 5 minutes
Regulatory Requirements for Systems and Procedure Packs in Belgium
In Belgium, producers of systems and procedure packs under MDR (EU) 2017/745 must ensure compatibility of combined CE-marked devices, draw up a declaration, register in Eudamed (currently voluntary), and notify FAMHP during the transitional period using dedicated forms, with specific rules for changes and acknowledgements.
Approximately 5 minutes
Overview of In Vitro Diagnostic Medical Devices Regulation in Belgium
The FAMHP oversees in vitro diagnostic medical devices (IVDs) in Belgium under Regulation (EU) 2017/746 (IVDR), applicable since 26 May 2022, with transitional provisions from Directive 98/79/EC and phased Eudamed registration requirements until mandatory in 2026.
Approximately 5 minutes
Procedure for Requesting Exceptional Use of Non-CE Marked Medical Devices in Belgium
In Belgium, FAMHP authorizes exceptional use of non-CE marked medical devices or IVDs under MDR Article 59 or IVDR Article 54 when justified by public health or patient safety needs, with no suitable alternatives available and significant expected benefit, via compassionate use for individual patients or national derogation.