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February 1, 2026
Approximately 5 minutes
Registration Requirements for Distribution and Export of Medical Devices in Belgium
Registration Requirements for Distribution and Export of Medical Devices in Belgium
1. Distributor Registration
Distributors must register on the FAMHP web portal in accordance with Article 4 of the Royal Decree of 15 November 2017 (effective 17 December 2017). Distributors are not required to register in Eudamed. Source: FAMHP Distribution and Export Page https://www.famhp.be/en/human_use/health_products/medical_devices_accessories/distribution-export/medical_devices
2. Importer Registration
Importers may register voluntarily in Eudamed's Actors module. Mandatory registration begins 28 May 2026 per Decision (EU) 2025/2371. FAMHP recommends early registration as Eudamed will become the primary data source. Source: FAMHP Distribution and Export Page https://www.famhp.be/en/human_use/health_products/medical_devices_accessories/distribution-export/medical_devices
3. Relabelling and Repackaging Obligations
Entities performing relabelling or repackaging under Article 16(2) of MDR or IVDR must notify FAMHP before market placement and submit a notified body certificate confirming QMS compliance within 28 days, via the FAMHP portal. Source: FAMHP Distribution and Export Page https://www.famhp.be/en/human_use/health_products/medical_devices_accessories/distribution-export/medical_devices
4. Resources and References
- Royal Decree: Available at official justice portal.
- Eudamed FAQs and actor registration Q&A on FAMHP site. Source: FAMHP Distribution and Export Page https://www.famhp.be/en/human_use/health_products/medical_devices_accessories/distribution-export/medical_devices
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