GMDN Codes for 'High Frequency Radiosurgical systems'

V

vinqua

#1
Our Greek distributor is now inquiring about the possibility of us asking for a separate GMDN category for 'High Frequency Radiosurgical systems' in order to differentiate our product offering from the traditional electrosurgical generators.

How could we ask the regulatory body to create such a new classification?
 
Elsmar Forum Sponsor
T

temujin

#2
Hi,

The GMDN site says "For services and queries please contact us."

...if you by "regulatory body" are referring to the GMDN agency, which in fact I believe is not really a regulatory body...


best regards
t.
 
A

Adele

#3
Hi Vinqua,

If there is no exisitng GMDN code that is suitable for your device, you are able to submit a new code proposal to the GMDN Agency. Onthe GMDN Agency's FAQ page there is the following:

Question:
Does the GMDN system allow for users to add special terms for their own use?
Answer
Yes! The GMDN structure has taken this into consideration and the coding system allows for codes from 0 to 9999 to be used locally by the user in their particular environment. These codes allow the user to enter terms to their imported GMDN data file that can be used to classify their own particular sub-set of data that is not part of the GMDN. However, one must be aware that these codes and associated data will be local (belonging only to that environment) and linked data cannot be exchanged with other GMDN users. Local codes can also be very useful when a user needs to add a new term of a device not yet found in the GMDN to their own database. The user should then submit this information to the GMDN MA for processing, (go to the GMDN Agency website for the application form). The local code assigned by the user will provide an essential link to the submitted proposed term and the reply received from the GMDN Agency showing the outcome of the application.


The GMDN home page is http://www.gmdnagency.com/.

Cheers,
 
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