In Reply to Parent Post by cjr978
I was hoping that someone on the forum may be able to help. Our German subsiduary wishes to start distributing product in Belgium. All our of products a CE marked Class I and IIa surgical instrumnets and Class IIb surgical implants.
My understanding is that Belgium do not have any special registration requirements in addition to the usual CE marking activity. However the German team seem to believe there are registration requirements with associated costs and a 6 month time delay.
I am assuming they may well be confusing registration for sellling purposes with a requirement to get hospitals and/or insurance companies to actually agree to use our devices - but cant find anything useful on the internet to help.
Can anyone help clarify the situation for me.
I don’t know exactly whether any special registration required to import medical devices into Belgium or not. But, you must have an authorized representative to put your product on the European market, Why don’t you enquire with them?. I understand that there are specific requirements regarding the use of languages (the information must be provided at least in the national languages: French, dutch and german
) and the notification of distribution activities for some devices. The information is available on the website http://www.afmps.be
. I would request you to find the information in aforesaid website or else contact directly to below address;
Federal Agency for Medicines and Health Products,
Health Products Division,
Place Victor Horta 40, boîte 40
B - 1060 Brussels
Phone: + 32 2 524.83.22
Fax: + 32 2 524.81.20