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February 3, 2026
Approximately 5 minutes
Fees for Medical Devices Manufacturers Based on Turnover in Belgium
Fees for Medical Devices Manufacturers Based on Turnover in Belgium
1. Overview of the Fee System
The financing system for medical devices in Belgium consists of an annual contribution for economic operators and an annual turnover tax, based on the Law of 20 July 2006. These fees support FAMHP activities related to market surveillance. Source: FAMHP Fees Based on Turnover Page https://www.famhp.be/en/human_use/health_products/medical_devices_and_their_accessories/manufacturers/fees_based_on_the
2. Annual Contribution for Economic Operators
- Amount for 2025: €415.74 per entity.
- Applies to: Manufacturers, custom-made device manufacturers, assemblers (systems and kits), authorised representatives, distributors, importers, and companies installing/maintaining devices outside hospitals as part of patient treatment.
- Registration: Via online portal at https://www.vas.ehealth.fgov.be/portal/en/.
- Calculation Aid: Flowchart available to determine number of entities. Source: FAMHP Fees Based on Turnover Page https://www.famhp.be/en/human_use/health_products/medical_devices_and_their_accessories/manufacturers/fees_based_on_the
3. Turnover Tax
- Rate for 2025: Maximum 0.3073%.
- Basis: Turnover from making available medical devices to retailers and/or end users in Belgium.
- Threshold: Indexed €40,000 (€50,290.17); tax due only above this.
- Retailers: Exempt from tax if supplying only to consumers. Source: FAMHP Fees Based on Turnover Page https://www.famhp.be/en/human_use/health_products/medical_devices_and_their_accessories/manufacturers/fees_based_on_the
4. Exemptions
- Distributors compliant with self-check guide are exempt from contribution.
- Entities with turnover below threshold are exempt from turnover tax (but may pay contribution if applicable).
- Compliant low-turnover distributors exempt from both. Source: FAMHP Fees Based on Turnover Page https://www.famhp.be/en/human_use/health_products/medical_devices_and_their_accessories/manufacturers/fees_based_on_the
5. Declaration and Payment
- Declaration: Via ‘Contributions’ application; submit certified form for previous year's turnover.
- Forms: Available in multiple languages for 2025.
- Payment: Invoiced by FAMHP at beginning of next year; pay only after receiving invoice with structured reference. Source: FAMHP Fees Based on Turnover Page https://www.famhp.be/en/human_use/health_products/medical_devices_and_their_accessories/manufacturers/fees_based_on_the
6. Additional Fees
- Service fees: For specific requests (e.g., certificates, clinical investigations).
- Reinspection fees: For additional inspections due to deficiencies.
- Details: Listed in medical devices fees table. Source: FAMHP Fees Based on Turnover Page https://www.famhp.be/en/human_use/health_products/medical_devices_and_their_accessories/manufacturers/fees_based_on_the
7. Contact and Resources
- Questions: contributions.meddev@fagg-afmps.be
- Q&A document available.
- Last updated: 06/08/2025. Source: FAMHP Fees Based on Turnover Page https://www.famhp.be/en/human_use/health_products/medical_devices_and_their_accessories/manufacturers/fees_based_on_the
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