Distributors of medical devices are legally required to register with the Federal Agency for Medicines and Health Products (FAMHP). Between 2022 and 2024, the FAMHP inspection services conducted a thematic action in order to verify that. Thanks to this action, nearly four hundred distributors were registered on the FAMHP web portal.
Effective from 17 December 2017, medical device distributors must register according to the Royal Decree of 15 November 2017. The royal decree explains how medical device distributors must register at the FAMHP web portal before starting their activities.
Between 2022 and 2024, the FAMHP's inspection service conducted a thematic action to check how many distributors had correctly implemented the registration on the web portal. The thematic action targeted Belgian and European distributors.
According to the Royal Decree of 15 November 2017:
• distributors must register through the FAMHP web portal before starting their activities;
• distributors have 45 days to complete the registration form made available to them by the FAMHP through the web portal. It is the distributors' responsibility to ensure that the answers on the form are correct;
• distributors who were already registered, or distributors who had already started their activities and were not yet registered before this decree took effect, have six months to confirm and/or complete their data through the FAMHP web portal.
Conditions of the thematic action
An incomplete registration means that the company did not complete the self-check questionnaire in the "My controls" section. The distributors involved were contacted by the authorised FAMHP inspection service by email with the official warning that the FAMHP would take measures for non-compliance with registration obligations, such as an unannounced inspection by an FAMHP inspector or a criminal fine.
If there was no response via email, official warnings were sent again by registered letter.
Results
The thematic action took place between 2022 and 2024, handling a total of 528 files.
All 528 distributors, based in Belgium or in the other European member states, received an official warning.
Upon receipt of an official warning:
• 396 distributors completed their registration;
• 94 companies declared or could proof that they had ceased their activities as medical device distributors;
• 38 companies took no action at all.
Conclusion
A large number of distributors had not yet completed their registration on the FAMHP web portal. Sending warnings by e-mail and/or registered letters has significantly improved the situation. The FAMHP continues to follow up on the files of the 38 non-compliant companies. Should the required adjustments not be made, the FAMHP will take appropriate action.
Monitoring and enforcement play a crucial role in ensuring compliance with legal obligations. With this action, the FAMHP wants to emphasise the importance of correct and timely registration in order to ensure the safety and traceability of medical devices.