Companies that are registered with the AFMPS (Agence fédérale des médicaments et des produits de santé) and whose products are in the Belgian reimbursement system have to make their annual declaration of turnover on the sale or provision of medical devices by March 31st, 2021 at the latest.
Please note that all economic operators, those involved in the manufacturing, distribution and import (whether or not you are subject to tax) must carry out the declaration of turnover.
Are you liable to pay tax?
- You are liable to pay tax if you provide medical devices to retailers and health care institutions. Therefore, you must provide all the information regarding the turnover declaration. Namely, the total turnover, the total turnover for medical devices and the turnover for the medical devices supplied in Belgium. The tax will be calculated based on this latter turnover.
- You are not liable to pay tax:
- If you do not supply medical devices to retailers and health care institutions
- If you are a retailer – retailer being a distributor who only supplies devices to private individuals
If are not liable to pay tax, however, you must complete the declaration of turnover by ticking the box: “Je ne distribue pas de dispositifs médicaux ou leurs accessoires à un détaillant ni à un utilisateur final, je ne suis donc pas sujet à la contribution”. (I do not distribute medical devices or their accessories to retailers, nor to end-users and I am therefore not subject to tax.)
Please note that the authority no longer accepts paper or email declarations.
Reminder: This document should be certified by an auditor or chartered accountant. It should be scanned and uploaded in the AFMPS application when completing the declaration of turnover.
If you have completed the registration via BEO BERLIN, you will be informed and prepared by us so that your registration and thus the reimbursement of your products will continue.