GMDN (Global Medical Device Nomenclature) Codes

[lucy apple]

Refer below links

1. TGA website, Presentation
2. FDA CDRH Presentation

3. HSA presentation on ACCSQ Medical Device Product Working Group

Thanks very much for sharing the above information.

 

[ocux81]

Thanks for the links

 

[bettyt]

This is how you get GMDN code from TGA website.
Go to TGA website and choose online e-business for medical device.

Choose secure login, put in your username and password,
now at the left hand corner choose medical device, there comes GMDN help, here you can give a search by using minimum 3 letters.
GMDN codes look like this
Probe, measuring instrument, radiation, Gieger Counter [38331]

If only you have a login and password you can acces it.
Betty Thalody

 

[invitro_spain]

Hello Folks:

There is a link to EDMA website https://www.edma-ivd.be/index.php?id=882 where you can download a EDMN to GMDN code database.

In the other hand, I found the following document from CEN with GMDN code description in this link (broken link removed).

I hope that both of them can be useful.

 

[bettyt]

The GMDN code for Medical devices manufactured in Australia who is looking to get TGA accreditation is available only in TGA website, log in and then you can access it.

 

[SteveK]

The GMDN code for Medical devices manufactured in Australia who is looking to get TGA accreditation is available only in TGA website, log in and then you can access it.

Just be warned GMDN codes from other web sites; including the TGA source, will not necessarily be current. GMDN make codes obsolescent and replace them with new codes.

You may be OK in the majority of cases – but some I have seen items listed in my categories that no longer exist e.g. the have expanded a item to have more variants and therefore new GMDN numbers.

Steve

 

[Tatiana 10]

how can we get these - for medical devices?
thank you!

 

[SteveK]

how can we get these - for medical devices?
thank you!

Hi Tatiana,

Welcome to the Cove!

To get the codes and the only way to know you have the current correct codes is become a member. GMDN keep you updated on any changes to your codes e.g. definitions.

https://www.gmdnagency.com/

Otherwise take your chances as indicated.

Steve

 

[Brain]

I am trying to get the GMDN codes without having to for out thousands of pounds. I only have few products but we need to make a decision on how to classify.
I hva ebeen on the Health Singapore site as well as the Hong Kong site but with no luck!
Please can someone help out with a downloadable/ printable version of the latest GMDN codes for medical devices?

Thanks

 

[SteveK]

Please can someone help out with a downloadable/ printable version of the latest GMDN codes for medical devices?

Thanks

Hi Brian,

It just does not exist (unless somebody has paid for every device listed)! As I have previously indicated there is the Australian TGA site:

https://www.ebs.tga.gov.au/ebs/ANZTPAR/PublicWeb.nsf/cuDevices?OpenView

- but as also indicated the GMDNs referenced in the ARTG submissions may not be up to date (i.e. could be obsolete). However, if you find very recent submissions for a (your) particular product there is a very good chance the code will be current (as refenced at the foot of each document).

Steve