Medical devices

On 07 December 2017, the Royal Decree (RD) concerning the "notification of a materovigilance point of contact and the registration of medical device distributors and exporters" has been published. This RD will apply 10 days after this publication, 17 December, 2017.

This legal text describes repealing and amending provisions of the legislation currently applicable to your domain of activity. We invite you to read this document

http://reflex.raadvst-consetat.be/reflex/pdf/Mbbs/2017/12/07/137427.pdf

This new RD aims, through its application, to set up a new registration procedure for all professionals in the sector with the principle of administrative simplification known as "only once". This principle consists of gathering as much information as is already known from other authorities / bodies such as data encoded at the Crossroads Bank for Enterprises (ECB) or the database of European VAT numbers - VIES

Finally, this legal document defines new modalities for market surveillance of medical devices.

Practical consequences of this publication

Prior to the publication of this RD, distribution notifications were made in the SADN/ABGD application (Authentic Source of Notified Distributors). The latter application will no longer be available and will be replaced by a new system.

A new web portal including 3 applications will be available to you, from 17 December 2017

These 3 new applications are called:

  • My company - application gathering general information about the company
  • My activities and my classes - application grouping activities such as manufacturers, distributors, exporters ... but also the risk classes of the devices that you put on the market or at disposal, like class I, IIa, IVD list A, IVD list B ...
  • My controls - application grouping “autocontrôle” guides and forms

What changes will be applied?

Distribution notifications are no longer made in SADN/ABGD. The new system will allow you to make a registration to declare your additional units of establishment, your activities, your classes...

The contribution system: currently this system is linked to SADN/ABGD. Following the publication, the "Contribution" application will be coupled with the data taken from "my company" and "my activities and my classes". In practice, this will not affect you.

For manufacturers and importers, previously, you were encoded in the SADN/ABGD system and you were known as a "distributor" in SADN. The above-mentioned RD includes the new European definition of distributor, and excludes the importer and the manufacturer of this definition. In practice, what changes is that you have to register yourself according to your exact activity [ex: manufacturer for the devices you make and/or distributor for the devices that you don’t manufacture but you distribute.]

What should you do?

We invite you to visit our web page to find useful information allowing you to access this new system. A dedicated access area will be available from 17/12 at the following address:

https://www.afmps.be/fr/le_web_portail_de_lafmps

https://www.fagg.be/nl/het_webportaal_van_het_fagg

User manuals are available on this portal to help you and guide you through your business registration.

We remain at your disposal for any questions relating to this new system by using the following email address:

support.portal@fagg-afmps.be

 

 

Contact :

Federal Agency for Medicines and Health Products 
Health Products Division 
Eurostation II
Place Victor Horta, 40 box 40
1060 Brussels

Last updated on 18/12/2017