GMDN (Global Medical Device Nomenclature) Codes

[medwise]

I agree with all the comments made by Marc and Ronen. You can research your competitors GMDN on the regulatory database of your region.

What kind of cryosurgical unit is it? general electrical or for opthalmics? Without the intended use of the device it is very difficult to assign a GMDN Code.

 

[sherley13]

510(K) Ownership

We ourselves(our company) and the vendor have an establishment registration and listing. We would be listed as the relabeler, reprocessor, distributor etc for device importing in to United States and the vendor would be listed as the manufacturer.

I also understand the 510K ownership to work as follows:
? If we own the 510K the vendor is not allowed to use that 510k for other distributors.
? If the vendor owns the 510K, he can use the 510K with any number of distributors.
? If another distributor of the vendor owns the 510K, we cannot use it unless authorized.

With that said, how is this enforced? How is our 510K protected so other distributors do not use it? Are the 510K numbers actually checked to determine which parties are using it? Where is it checked? How often is it checked? Does misuse occur?

Please guide me on the above.

 

[Ronen E]

Re: 510(K) Ownership

Hi,

As far as I know, a device cleared under a 510k can be distributed in the USA by anyone (given it is the exact same device), regardless of 510k ownership. However, if the 510k includes registered trademarks etc., that would prevent others from distributing under the same labeling without formal settlement with the owners, and hence such other parties might need their own 510k. Not 100% sure, though - it feels like a grey area that needs plunging into the details. A legal practitioner's advice may be required as well.

Cheers,
Ronen.

 

[BusSupport]

I have a similar GMDM code question. All I need is the GMDM of <dressing scissors> [equivalent of UMDNS 13-431]. I have tried going through the Hong Kong page, but somehow can't find the listings there.

 

[BusSupport]

I was just alerted that these numbers are copyrighted and without public access. I do appreciate the information very much!

 

[Sam Lazzara]

https://www.freedom-group.org/Let's here it for FREEDOM form GMDNs!

The draft FDA guidance from 2013-09 for their "Global" Unique Device Identification Database (GUDID) has received numerous comments from large companies, trade organizations, non-profits, etc.

All of the comments are here.

One of the comment letters came from "The Foundation for Research to Eliminate Economic Distance and Opacity via Multilateralism"...hmmm I guess we can call it FREEDOM....wow!

From their website: Freedom-Group's mission is to investigate means to Eliminate Economic Distance and Opacity via Multilateralism by correlating and interlinking existing statistical regimes, classifications, ontologies, nomenclatures, and taxonomies, and regulatory and private-industry schema that carry the same.

For those of you who are frustrated in their attempts to get "GMDN" numbers without joining the club, you will love this FREEDOM comment letter. You will need to click on the "View Attachment" link towards the bottom of the page.

I wonder if FREEDOM has a membership fee?

 

[Oneves]

I work with medical vacuum plants, medical air plants and oxygen plants. All medical devices class IIb.
Did you know if those MD have GNDM codes?

Thanks

 

[medwise]

Hi Oneves,

I can help you finding those if you can provide me the intended use of those devices. If you prefer confidential guidance then please email me on romit18@hotmail.com.

Cheers
R

 

[Katalina]

You can find the code number and name without the long, official description on the Australia TGA website, under Public TGA Information. You can search, see if someone else has a license, then click the down arrow to the left of the company name to see the Public ARTG Summary. The code number and name are at the bottom of the page, along with that company's description. I can't yet post a link, so type www and then a period, then ebs and a period, then tga and a period, then gov and a period, then au and a backslash.

https://www.ebs.tga.gov.au

 

[Mark Meer]

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.