Regulatory Open Forum

 View Only

  • 1.  GMDN Codes

    Posted 12-Jun-2017 11:16
    Good morning All!

    I am having a lot of trouble locating GMDN codes. Does anyone have experience on an efficient way to find these codes? I am trying to find a code that would be a product identifier for a thigh wrap. Any and all advice is welcomed! Thank you in advance!

    Kindly,
    Allison

    ------------------------------
    Allison Hogan
    Charlotte NC
    United States
    ------------------------------


  • 2.  RE: GMDN Codes

    Posted 13-Jun-2017 08:48
    Unfortunately, GMDN is a profit making organization and the only certain way to have access to all the codes is to pay their membership fee. That said, sometimes you can find other approaches. If you have a competitor, their GMDN codes are sometimes listed in publically available registration documents for various countries that use GMDN codes for product identification (think Australia, Hong Kong etc). A number of years ago, a couple of the smaller Asian countries had GMDN look-ups on their websites. However, when I looked recently they were no longer there - I suspect the lawyers for GMDN told them to cease and desist.

    g-

    ------------------------------
    Ginger Glaser RAC
    Vice-President, Quality and Regulatory Affairs
    Maplewood MN
    United States
    ------------------------------

    Original Message


  • 3.  RE: GMDN Codes

    Posted 13-Jun-2017 08:57
    The most accurate method would be by searching at https://www.gmdnagency.org/
    Unfortunately, this privilege requires $$ subscription, which for small companies is not trivial.

    There are a couple of exported lists floating around on the internets, but they're dated, so they may not have the code for your product if it was added recently.
    You could also try Australian TGA product registration database, and search for a similar device to yours. The public summary of the registered device typically lists the GMDN code.
    http://tga-search.clients.funnelback.com/s/search.html?query=&collection=tga-artg

    ------------------------------
    Michael Zagorski RAC
    Pittsburgh PA
    ------------------------------

    Original Message


  • 4.  RE: GMDN Codes

    Posted 13-Jun-2017 10:20
    Dear Allison-
    GMDN terms (codes) may be purchased from the GMDN Agency in the UK.   Annual Membership fees are based on company sales.  There is a scaled rate for purchasing additional terms - code credits do not expire!  Adding a term cost about 200 euros when I last submitted one. To see membership information go to:  Membership Prices - GMDN Agency

    ------------------------------
    Stacey Henning


    United States
    ------------------------------

    Original Message


  • 5.  RE: GMDN Codes

    Posted 13-Jun-2017 10:53
    Yes, you do have to pay a fee.  However, it isn't just to make money since you have voting rights on the classifications which could get your device out of a very general classification into a very specific classification that may assist you in bids or introduction into other countries.  They are also required for many registrations including FDA UDI.  The cost for a 10 million dollar company is $900/yr after the first year and that will get you 15 codes.  They do change and obsolete codes as 2 of ours have changed in the last year so any publishes list is most likely not accurate since as a member you are not permitted to share the list.
    Their website states they are a public charity which is not necessarily a money-making organization.  It all depends on what you need as a company due to what your customers require and how involved you wish to be in the global development of medical device classification.

    ------------------------------
    D Michelle Williams

    Hagerstown MD
    United States
    ------------------------------

    Original Message


  • 6.  RE: GMDN Codes

    Posted 15-Jun-2017 02:53
    I will second Michael's suggestion to search the Australian Register of Therapeutic Goods. It's extremely easy (and free) to search for similar products, and the GMDN code is publicly available. 

    Once you've searched for your product type, select the arrow to the left of the product name and click on Public ARTG Summary.

    ------------------------------
    Megan Kane
    Sabre Medical
    Australia
    ------------------------------

    Original Message


  • 7.  RE: GMDN Codes

    Posted 15-Jun-2017 11:29
    Interesting topic.

    The new Medical Device Regulation states:

    To facilitate the functioning of Eudamed, an internationally recognised medical device nomenclature should be
    available free of charge to manufacturers and other natural or legal persons required by this Regulation to use
    that nomenclature. Furthermore, that nomenclature should be available, where reasonably practicable, free of
    charge also to other stakeholders.

    I am interested in how GMDN will fare with this requirement.  Will they have to stop charging or will another organization or agency take over as the major global device nomenclature provider?

    If anyone has any insight into how this will be achieved, please post.

    Thanks,

    ------------------------------
    John Minier, RAC
    Consultant, Principal
    Minier Medical Device Consulting
    john@johnminier.com
    1(914)850-4432
    Highland Mills, NY
    United States
    ------------------------------

    Original Message


  • 8.  RE: GMDN Codes

    Posted 15-Jun-2017 11:48
    ​One word of caution re: using the Australian database for searches (although I agree that this is a good strategy) - I have seen cases where there are mismatches between the "main" GMDN code and the Australian code.  In theory they should be the same, but I think sometimes things get created/deleted/updated in the GMDN database and it takes awhile for the Australian database to get caught up.

    ------------------------------
    Elizabeth Goldstein RAC
    Regulatory Affairs Specialist
    Medtronic Vascular
    Santa Rosa CA
    United States
    ------------------------------

    Original Message


  • 9.  RE: GMDN Codes

    Posted 23-Jun-2017 11:59
    If you do not have an account with the GMDN agency, you can also search through FDA's preferred terms if you have access to GUDID.  The term names and descriptions are the same as GMDN, FDA has assigned a four letter code in place of the the GMDN code number. This will enable you to identify codes until you establish your account with GMDN . 

    You can also search for similar products on the public GUDID page (AccessGUDID - Identify Your Medical Device) and then view the GMDN terms/definitions reported by other companies.

    ------------------------------
    Alyssa Tarzia
    Santa Barbara CA
    United States
    ------------------------------

    Original Message


Related Content