Auatralia's "GMDN" coding system is a bit different from the original GMDN system, so sometimes the codes would be different.
GMDN (Global Medical Device Nomenclature) Codes
- Thread starter chris1price
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Auatralia's "GMDN" coding system is a bit different from the original GMDN system, so sometimes the codes would be different.
Maybe this isn't the thread for it, but I'd really like to follow a discussion of the actual value of nomenclature codes.
I'm in agreement with previous posts in this thread complaining about the GMDN membership costs.
If you manufacture a single device, and Australia (for example) is demanding the GMDN code, what choice is there but to pay the full membership fee - and for what? To lookup a single 6-digit code??
Maybe, as Marcelo says, it is just "the cost of doing business". But in this case I'm particularly irked because the cost really doesn't seem to reflect the value. Contrast this with purchasing standards - also expensive - but I can justify this cost because the information is of practical value.
Your example is not good. If you enrol on the Australian eBs system (which you need anyway for registering your device in Australia) you get free access to the TGA's "GMDN" system.
Thanks for pointing that out Ronen E.
Ok, then Japan, Turkey, wherever... The point is that paying membership fees to lookup a code where the actual practical value of the code is questionable, is a tough pill to swallow for a lot manufacturers.
Also, I like the quotes in TGA's "GMDN". If the TGA maintains codes that are actually different from the official GMDN codes, I wonder what the GMDN agency has to say about TGA's "unofficial" system. Kind of defeats the purpose of a unified global system, no?
...Forgive me, I seem to be in a ranting mood... and nomenclature codes has always been something that's irked me...
The only things that are defeated by the TGA's approach to this issue are unfairness and greed. I couldn't care less what the GMDN agency thinks of it, and I'm not the TGA's representative anyway.
Cheers,
Ronen.
S
SteveK
The GMDN codes from TGA are only different because they are not necessarily updated. GMDN deletes codes, replaces with new ones, changes definitions etc. That?s what you get from a secondary source.
Steve
Steve
I struggle to see what use a code is if it keeps changing?
Are you expected to treat the codes for your products as controled documents which you issue out to authorities etc....when GMDN deign to change the code do you have to alert the people who have received the code....do GMDN even tell you they changed your code? if not, how do you and the authorities releate the code you have back to the definition??....I'm confused?
Are you expected to treat the codes for your products as controled documents which you issue out to authorities etc....when GMDN deign to change the code do you have to alert the people who have received the code....do GMDN even tell you they changed your code? if not, how do you and the authorities releate the code you have back to the definition??....I'm confused?
S
SteveK
That?s the trick. You have to be a member of GMDN to get the updates. What could happen is that they originally might have a number say based on an (original) ECRI UMDN for a ?widget?. But then (I assume via a request or their own choice) they then split this up into a ?single use widget? and a ?reusable widget?. The original ?widget? number then becomes redundant and two new numbers are issued.
Steve
Steve
Seems there is a general consensus that the GMDN agency is gouging manufacturers.
Can anyone actually justify the adoption/existence of the GMDN system?
(and by that I mean evidence of actual utility... not just what is put forward by the GMDN agency & user guides)...
There?s a lot of regulatory requirements that does not help at all the manufacturers. But it will usually be justified by the regulators that set the requirements - in this case, basic traceability and easy recognition and general labeling of several thousand types of different medical devices.
In those cases, for the manufacturer, the only real justification is: because the regulator said so (even if it?s not value-added from the standpoint of the manufacturer).
So, as I said before, it?s still the case of the cost of doing business, even if you think you are not getting much in return.
In those cases, for the manufacturer, the only real justification is: because the regulator said so (even if it?s not value-added from the standpoint of the manufacturer).
So, as I said before, it?s still the case of the cost of doing business, even if you think you are not getting much in return.
Classic. Let the cat guard the cream.
They have every interest to make it difficult for anyone that isn't a member.
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