Distributing Medical Devices in Belgium - Specific Registration Requirements

[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.
Many thanks
Chris

 

[Stijloor]

A Quick Bump!

Can someone help Chris with this?

Thank you very much!

Stijloor.

 

[Stijloor]

One More Quick Bump!

Can someone help with this?

Thank you very much!!

Stijloor.

 

[bio_subbu]

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.
Many thanks
Chris

Hi Chris

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

Regards
S.Subramaniam

 

[Pads38]

Looks like registration is required for Class 1 devices.

See:

http://www.fagg-afmps.be/en/human_use/health_products/medical_devices_accessories/

That's the Belgian Federal agency.

 

[cjr978]

Thanks everyone, its sounding like my initial suspicions are correct.

I will use the links suggested to contact the competant authority and get something on the record to this effect. That will keep our people happy that we arent breaking any laws

 

[Wendy0519]

Sorry for troubling. I have a question regarding this.
We are a Non-EU medical device manufacturer which has CE and ISO 13485 certificate. Doctors from UK and Belgium hospital would to use our product ( category IIb) now, but we don’t have any distributors in the Europe.

I would like to know,

1) Could we sale our product from China to EU hospitals directly?
2) If so, is there any specific requirements for hospitals?

 

[moounir]

Hi,

If you are located outside EU, you'll need first to appoint an Authorized Representative. This is someone that is located in Europe and will represent your business.

As soon as you have that, you can check for a distributor. The Authorized Representative can help you register your products if it is on your agreement.

Let me know if this helped you.

Regards.