Hi

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 codes (http://www.edma-ivd.be/index.php?id=4), but cant find an equivalent for medical devices.

Hi

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 codes (http://www.edma-ivd.be/index.php?id=4), but cant find an equivalent for medical devices.
Ask your Notified Body or search this database. (http://search.mdco.gov.hk/english/sd/sd_gmdn/sd_gmdn.php)

We still use the UMDNS on our certificates, since there is the big fuzz on the very high license fees...

Until now, none of our customers needed the GMDN, UMDNS was always sufficient.

~ghw

i hope you like it..! (Attached)

But how does the GMDN differ from the UCRI & UMDNS codes? I've been asked specifically for the GMDN code. Also, the link Al Rosen had posted to a searchable database is no longer active.

The Hong Kong Government have made the GMDN database available on their website - http://search.mdco.gov.hk/english/sd/sd_gmdn/sd_gmdn.php.

Adele,

Thanks, but this link is "dead".

Try http://www.mdco.gov.hk/eindex.html which is the home page of the Department of Hong Kong and link through from their to the GMDN page.

adele,

thanks, but this link is "dead".

hi i am working with pti, medical device manufacturing company, i would like to know the gmdn code for all opthalmic strips are same ...from where i am able to acess this ....

RAVI12081979,

i would like to know the gmdn code for all opthalmic strips are same ...from where i am able to acess this ....


For which purpose do you need the GMDN codes?

We still use the UMDNS codes on our certificates, and none of pur customers needs a GMDN code.

At least here in Europe there is no legally binding requirement for GMDN.

Dear all

We need GMDN code for purpose of product registration....GMDN code for Strips are same for all the strips?

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

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

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

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

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!

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!