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COVID-19: electronic files submission

Following the recommendations of the Belgian National Security Council regarding the coronavirus epidemic, the FAMHP encourages employees to work more from home. Therefore, we ask all our partners to submit their files to us electronically as much as possible.

New nomenclature for incidents with medical devices

From January 2020 there is a new nomenclature applicable for manufacturers reporting an incident with a medical product to the FAMHP. The FAMHP advises manufacturers of medical devices to already change their internal codes to the new nomenclature codes.

Implants and certain invasive medical devices: as of June 3, 2019, the FAMHP takes over the RIZIV notification database.

Every company selling implants and certain invasive medical devices in Belgium must report the data for these in a notification database. The notification of these medical devices applies as a condition for reimbursement of the obligatory insurance for health care. From June 3, 2019 the notification of these medical devices in the database will occur via a new online application at the Federal Agency for Medicines and Health Products (FAMHP).

Medical devices: autocontrol and administrative simplification. End of the transition period on 17th June 2018.

As a result of the changes in the legislation on medical devices, the FAMHP has set up a web portal in order to facilitate registration. The transition period ends on 17th June 2018. From then on, all the operators that fail to register will no longer be able to legally carry out their activities.

Survey of external satisfaction

The federal agency for medicines and health products (famhp) will soon launch a first satisfaction survey to assess the quality of its services and products. The results of this will be communicated at the end of 2013 and will be used to improve the delivery of FAMHP services.

Nouvelle législation relative aux dispositifs médicaux

Après l’arrêté royal (AR) du 21.01.2009 relatif aux dispositifs médicaux implantables actifs, c’est au tour de l’AR du 17.03.2009 concernant les dispositifs médicaux d’être publié au moniteur belge ce vendredi 27.03.2009.

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