GMDN (Global Medical Device Nomenclature) in EU and US

J0anne said:

[FONT=&quot]According to the GMDN Agency;[/FONT]
[FONT=&quot]
[/FONT]
[FONT=&quot]
[/FONT]
[FONT=&quot]'the following countries/regions are introducing the GMDN as requirements within the next 12 months and are either preparing or have already passed relevant legislation:
[/FONT]
[FONT=&quot]USA[/FONT][FONT=&quot][/FONT]
[FONT=&quot]European Union
[/FONT]
[FONT=&quot]Other countries are discussing with us how they can use the GMDN to improve regulatory systems.'[/FONT]

[FONT=&quot][/FONT]
[FONT=&quot]
[/FONT]
[FONT=&quot]Can anyone verify this, together with supporting evidence, independent of the GMDN Agency or their website? [/FONT][FONT=&quot]
[/FONT]

Click to expand...

SteveK said:

Hi Jo,

I found this from the Irish Medicines Board:

Question: Do I need the GMDN (Global Medical Device Nomenclature) code for devices I am registering?
Answer:
The Irish Medicines Board requires that all applications for registration of a device are accompanied by an appropriate GMDN code. If there is no suitable GMDN code for your device we advise that you contact the GMDN agency to request one.

I've checked other regulatory sites in Europe i.e. MHRA, afssaps, bfarm, salute and swissmedic but have not found anything as obvious - however relying on translation software in some cases does not help the search.

Steve

Click to expand...

Martin IT said:

Hello,

Sorry, I've checked on the Italian Ministry of healt webpage, but I didn't found anything on this topic (just a link to GMDN's website).

Martin

Click to expand...