Belgian Competent Authority Registration

[Dave-h]

Dear all,

I work for a medical device manufacturer in the UK. We are registered with the MHRA and have a UK Notified Body. We sell class 1, 2a, 2b & 3 devices.

If we have a sales office in Belgium, do we need to register either ourselves, or that office with the Belgian competent authority (FAMHP)?

Thanks in advance for your kind help.


Dave

 

[Stijloor]

A Quick Bump!

Can someone help?

Thank you very much!!

 

[Ronen E]

Dear all,

I work for a medical device manufacturer in the UK. We are registered with the MHRA and have a UK Notified Body. We sell class 1, 2a, 2b & 3 devices.

If we have a sales office in Belgium, do we need to register either ourselves, or that office with the Belgian competent authority (FAMHP)?

Thanks in advance for your kind help.


Dave

Hi,

My impression is that Belgium doesn't require a special, additional registration above and beyond the "general EU" one that you already have with MHRA, with implants being a possible exception.

Have a look at this post, apparently by someone knowledgeable from Belgium (a bit old, though). Of course the AR part is irrelevant to you.

Why not contact the medical devices section of FAMHP directly, and ask them?

Contact :

Federal Agency for Medicines and Health Products

MedicHealth Products Division
Eurostation II
Place Victor Horta, 40 box 40
1060 Brussels

Fax : +32 (0)2 524 81 20

Email : [email protected]

The above is the result of ~20 minutes online research, in Elsmar and FAMHP's website.

Cheers,
Ronen.

 

[TS.Verm]

Hello,
Your sales office needs a license from FAGG as a distributor.
I don't think your products need to be registrated again, but better ask FAGG themselves.
Good Luck.