Italian Device Classification - CND

[Dave-h]

Dear All,

In Italy, I am told that there is a national medical device coding system, similar to GMDN, that is to be used as a part of their new product registration system. The system is known as CND.

Does anyone know the details of CND and how it might differ from GMDN. I've so-far been unsuccessful in web searches.

Thanks,

Dave

 

[Ajit Basrur]

Refer this - http://www.ministerosalute.it/dispositivi/dispomed.jsp

Sorry in Italian

 

[Dave-h]

Thank you Anjit, that is most helpful.

There is a link there to a page that converts between GMDN and the CND codes.

Regards, Dave

 

[NewRegMan]

Dear Dave,

could you kindly post this link?

I went to the webpage but couldn't find it.

Thanks a lot in advance & best regards,
Guido

 

[Ajit Basrur]

Dear Dave,

could you kindly post this link?

I went to the webpage but couldn't find it.

Thanks a lot in advance & best regards,
Guido

http://www.ministerosalute.it/dispositivi/classificazione.jsp?menu=strumentieservizi&id=21

 

[Dave-h]

Dear Ajit,

Thanks for posting your reply, I've been in Italy for the last couple of days working with our Italian office to register our products - or at least start the process!

We found that when registering the products, you need to be patient as their system is not the most stable!

We were using the English version of their system, but even then, there are many parts that are still in Italian, in particular the pop-up cautions! Without an Italian speaker close at hand, it would have been much more tricky. It is also useful to have the system instruction manual to hand.

Regards,

Dave

 

[Ajit Basrur]

Thanks for the update, Dave

 

[zypher005]

Dear Ajit,

I am also looking for more information for GMDN and the CND codes. However, all above links are out of date now. It's so hard to search the CND & GMDN info in the Italian pages. Would you be so kind to help me? Thanks in advance.

Best regards,
zypher005

 

[somashekar]

Dear Ajit,

I am also looking for more information for GMDN and the CND codes. However, all above links are out of date now. It's so hard to search the CND & GMDN info in the Italian pages. Would you be so kind to help me? Thanks in advance.

Best regards,
zypher005

Classificazione Nazionale Dispositivi (CND). CND is a hierarchical, multilevel, “tree-like” structure of 22 mutually exclusive main categories and 144 groups. In large part is it aligned with the international nomenclature, that is, the Global Medical Device Nomenclature (GMDN).
This was around 2007 / 2008
Now...
GMDN The Global Medical Device Nomenclature (GMDN) is a system of internationally agreed terms used to identify medical devices.
It is used by regulators, hospitals and manufacturers to identify medical devices that are of the same generic type. This supports market surveillance, adverse event reporting, product recall and other healthcare management activities.

About GMDN Membership
The GMDN Agency is responsible for maintaining the GMDN. Access is only available to Members and membership is priced according to organisation type and size. The membership process is completed online and access to the database is immediate upon completion of payment which can be done on-line or by invoice.

Members search the online database for the GMDN Term that describes their product. Each GMDN Term has a 5-digit Code that is revealed using a code credit. The GMDN Code can then be given to a regulator or customer for their intended use.

To ensure there is a GMDN Term for all medical devices, for example to meet the need for product innovation, the database is updated using change requests from Members.

.... from the GMDN url

 

[zypher005]

Thanks for your prompt reply. I think I find the right place for CND codes. Just need to take a lot of time to translate the Italian language information.