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Make your company (better) known from the Belgian Federal Agency for Medicines and Health Products (FAMHP).

20 August 2019 - 9:26

You are developing or commercializing a e-health/medical device solution? You would like to be better informed of new initiatives, regulatory changes and updates, latest trends impacting your e-health/medtech business? You would like to ease administrative procedures linked to your projects? You would like to be known of Belgian health authorities?

 

We strongly advise you to register your company at the Belgian Federal Agency For Medicines and Health Products – FAMHP. The registration is quite easy!

 

Please note that this registration is not mandatory except for:

  • Distributors active in Belgium based in or outside Belgium (a distributor being any natural or legal person in the supply chain, other than the manufacturer or importer, who makes a product available on the European Union market);
  • Exporter based in Belgium who, for instance, is willing to apply for a Free Sale certificates;
  • Companies that need NIHDI (INAMI):
    • Manufacturers
    • Importers
    • Distributors

 

The online registration of your company is structured into 6 parts:

  • My enterprise
  • My activities
  • My address book (for importers and distributors only).
  • My controls
  • My medical devices (mandatory only for implants and long-term invasive medical devices).
  • Annual contribution.

The annual contribution is due by companies selling directly to retailers or final consumers (for instance companies selling to an hospital). If the manufacturer is not selling the medical device to retailers or final users but only to wholesalers, then the contribution is not due. The contribution amounts to 500 EUR by year or 0,39% of the turnover. Any company selling to retailers or final consumers need to fill in this part and declare its turnover.

 

The registration can be submitted here: https://www.vas.ehealth.fgov.be/webmedseip.

Should you have any question, do not hesitate to contact directly Azèle Mathieu, manager of lifetech.brussels and representing the cluster members to the Division Health Products of FAMPH.