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Distributing Medical Devices in Belgium - Specific Registration Requirements

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Related Topic Tags
ce mark and ce marking, class i medical device, class ii medical device, implantable medical devices (imd), medical device standards and regulations, medical devices (general), surgical products
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  Post Number #1  
Old 23rd January 2012, 12:20 PM
cjr978

 
 
Total Posts: 15
Please Help! Distributing Medical Devices in Belgium - Specific Registration Requirements

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

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  Post Number #2  
Old 24th January 2012, 04:22 AM
Stijloor's Avatar
Stijloor

 
 
Total Posts: 14,702
Re: Distributing Medical Devices in Belgium - Specific Registration Requirements

A Quick Bump!

Can someone help Chris with this?

Thank you very much!

Stijloor.
Thanks to Stijloor for your informative Post and/or Attachment!
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  Post Number #3  
Old 25th January 2012, 03:54 AM
Stijloor's Avatar
Stijloor

 
 
Total Posts: 14,702
Re: Distributing Medical Devices in Belgium - Specific Registration Requirements

One More Quick Bump!

Can someone help with this?

Thank you very much!!

Stijloor.
  Post Number #4  
Old 25th January 2012, 06:10 AM
bio_subbu's Avatar
bio_subbu

 
 
Total Posts: 596
Re: Distributing Medical Devices in Belgium - Specific Registration Requirements

Quote:
In Reply to Parent Post by cjr978 View Post

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
Thank You to bio_subbu for your informative Post and/or Attachment!
  Post Number #5  
Old 25th January 2012, 06:47 AM
Pads38

 
 
Total Posts: 524
Re: Distributing Medical Devices in Belgium - Specific Registration Requirements

Looks like registration is required for Class 1 devices.

See:

http://www.fagg-afmps.be/en/human_us...s_accessories/

That's the Belgian Federal agency.
Thank You to Pads38 for your informative Post and/or Attachment!
  Post Number #6  
Old 28th January 2012, 02:42 AM
cjr978

 
 
Total Posts: 15
Re: Distributing Medical Devices in Belgium - Specific Registration Requirements

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
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