Good Morning All
About a year ago I took over as the Quality lead for a company making x-ray emitting medical devices. I have recently reviewed our GMDN account and technical file and found what I believe to be a potential discrepancy.
Without giving specifics (and getting in trouble for...
I work within the IVD and Medical Device field.
We have GMDN numbers assigned to our products, however I am now being asked about UMDN numbers (which I've not come across before).
Please can someone advise if a UMDN is different to a GMDN and whether or not we need to assign both...
For FDA GUDID, is there any reason why I should pay for a GMDN membership instead of using the freely available FDA PT Code?
One of my colleagues seems to think that FDA PT Codes are only temporarily available and we will all eventually have to acquire GMDN membership. I do not...
Hi, I have a question regarding UMDNS and GMDN codes.
When a preferred term has been retired, what are the implications for a DoC (declaration of conformity) certificate for a manufacturer who used the retired term?
If there is a new DoC, will the manufacturer have to choose a new preferred...
I have given some GMDN codes that are needed for a registration and do not know the description.
I have tried several free links on the forum (e.g. TGA,) and my codes are not mentioned and do not wish to pay for GMDN membership can anybody provide me the description for the following codes...
I know some topics have already been opened about GMDN codes but they are out of date now.
Could anyone who is already registered as a GMDN member kindly give me the
code for "spinal fixation system"?
Or do we have any way to get them without paying 1500$ fees?
Many thansk in...
Hi, I'm sure many of us here are looking for GMDN code from time to time.
I've recently found a searchable database from HSA Singapore site.
I'm not sure if posting it here would violate any copyright terms, but i'm putting it up to share with the forum.
Forum MOD pls feel free to take it down...
We would like to put both our indications for use and intended use in our user manual.
Is this safe to say:
- Intended use: is the same statement as what we submit in the 510(k) in the "indications for use" page that is made public
- Indications for use: is the more detailed version of the...
I have been asked for the GMDN codes for our products as part of product registration. Is there any way to access the codes without having to be a member of the GMDM, which costs €1500 + €1000 per year?
For IVDs, I can find a cross reference between EDMA and GMDN which lists all IVD...