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GMDN (Global Medical Device Nomenclature) Codes

B

Bunbury

#11
Re: GMDN (Global Medical Device Nomenclature), UMDNS & AMDNS Codes

Hi all,

I'd like to return to this topic. We can no longer view GMDN codes on the Hong Kong Dept. of Health website because HK recently switched to the Asian Medical Device Nomenclature System (AMDNS) for their generic device descriptions. It is based on the UMDNS. http://www.mdco.gov.hk/english/news/news_20090622.html

I find this to be an interesting development -- especially in light of the fact that it was several asian countries, including HK, which demanded the GMDN codes from us in the first place.

That said, does anyone know of another source for GMDN codes?

Regards,
Shawn
 
B

Bunbury

#12
Dear all, We need GMDN code for purpose of product registration....GMDN code for Ophth. Strips are same for all the strips?
RAVI..., You're right, some of the top markets either require or request GMDN codes for product registration -- Australia/New Zealand and Japan among them.

As to your question on types of strips with the same code, I would assume not. Ophthalmic products are in category 8.

There are 12 GMDN categories (at least there were last time I looked on the Australian TGA website). The fact sheet is from 2006, but I don't expect it's changed. Someone please correct me if this information is out of date. http://www.tga.gov.au/devices/fs_gmdn.htm

01 - Active implantable devices
02 - Anaesthetic and respiratory devices
03 - Dental devices
04 - Electro-mechanical devices
05 - Hospital hardware
06 - In-vitro diagnostic devices
07 - Non-active implantable devices
08 - Ophthalmic and optical devices
09 - Reusable instruments
10 - Single-use devices
11 - Technical aids for disabled persons
12 - Diagnostic and therapeutic radiation devices

Regards, Shawn
 
K

Kary13

#13
Stupid question probably but where exactly is the UMDNS located? On a certificate once the product is registered or or the CE-certificate? :bonk:
 
B

Bunbury

#14
Stupid question probably but where exactly is the UMDNS located? On a certificate once the product is registered or or the CE-certificate? :bonk:
Hi Kary13,

To my knowledge the UMDNS is not used on a certificate -- it is just requested for categorization, and it would never appear on a CE mark certificate. If anyone else is aware of whether UMDNS is used on a certificate, please let us know. Now, I do know that the GMDN code, not the UMDNS, is required on the Declaration of Conformity for Australia. I'm not sure about other countries.

As far as the previous question about what the difference between the two is, the answer is not that much. UMDNS has been around longer. When the GMDN was developed, it incorporated most of the UMDNS codes. GMDN came about because the requirements for the MDD included a nomenclature system (resulting standard: EN ISO 15225). At about the same time there was a move by the GHTF to harmonize, so the GHTF supports it over other nomenclatures.

Regards, Shawn
 
K

Kary13

#15
Sorry about the statement about the certificate then but previous intervention were mentionning using the UMDN codes on the certificates... hence the question.

So if we want to comply with ISO 15225, we have to determine the appropriate GMDN code but in order to ensure full compliance with the wording, any other way than to register in the database?

Also, I have read the section on the codification in the user manual for the GMDN database but cannot find much reference on software, specifically computer assisted diagnostic software? Do you think it has to be included in the diagnostic category although it is not a diagnostic tool per say?

Thanks!
 
J

jsax101

#16
Hi,

I am also looking for the list of GMDN codes for medical devices. Can anyone help? I've tried all the links listed, but they're all dead.

Thanks!
 
D

Dave.R

#17
Hi. I also am looking these GMDN codes in Ireland. I am told by the regulatory body that a cost effective method is to team with another company and share the costs. However that is not possible for me but may be of use to anyone else?
I am wondering could anyone help me with a GMDN code for single use items. That would be something like a device such as surgical swabs, surgical towels and draping etc? I was wondering is there a simple list to pick the appropriate code from. I have gone through the 15225 and see we fall under code 10 however I'm told its a six digit code. I am trying to determine the four other digits but this makes little sense to me. Would appreciate any comment. Thanks
 
Y

yu_chas

#18
Hi, I am looking for GMDN code for Ultrasound Scanner. Does anyone know what the appropriate code is? I have searched for several site but can't find any information of it.

Thanks in advance.
 
#20
Some time ago I found this:- www .tuvamerica.com/tools/forms/UMDNS.DOC - OBSOLETE BROKEN 404 LINK(s) UNLINKED - PLEASE HELP - REPORT POSTS WITH BROKEN LINKS
The UMNDS numbers go up to 18140.
I latter was supplied with some GMDN numbers (via subscription). To my surprise I found that two devices in this (UMDNS) range had the same numbers as the GMDN numbers I was supplied with. Draw your own conclusions - I could not possibly comment, but I always thought 13126 was a nice number.

Steve
 
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