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  • 1.  GMDN code

    Posted 25-Feb-2016 09:42

    Dear All,

     

    Have you guys been working on the GMDN code? I am searching around and realise that it seems not mandatory requirement to require the use of GMDN for medical device registration and marketing in most countries such as US, Canada etc., so far only Australia, Japan, Italy, a few countries require GMDN code for registration.

     

    Does anyone register as the membership of GMDN Agency? As a membership, does agency identify a code for our products or we need google the database to identify a code by yourself?

     

    Thanks for any comments!

     

    Shaoying

     

     

    Derma Sciences: A Regenerative Tissue Company

     

    Shaoying Wei | International Regulatory/Doc. Specialist

    104 Shorting Road, Toronto, Ontario M1S 3S4

    P: 416-299-4003 x 268 | F: 416-299-4912

    E: swei@dermasciences.com

    www.dermasciences.com

    http://www.dermasciences.com/email/ribbon.jpg

    A TISSUE REGENERATION COMPANY

     

     



  • 2.  RE: GMDN code

    Posted 26-Feb-2016 03:47

    Hi Shaoying,

    I have a GMDN membership. Once you're a member, you can browse GMDN database all you want by using different keywords that are related to the medical device you're interested in. So you're browsing GMDN term names and term definitions rather than codes. The membership fee includes a certain number of GMDN codes that you can reimburse when you find a GMDN term name/definition that you'd like to take into use.

    If you can't find a GMDN term for your device, you can contact GMDN agency to propose a new GMDN term or ask for an existing term entry to be modified.

    Hope this helps, Shaoying.

    Regards,

    Tiina

    ------------------------------
    Tiina Tyni
    Regulatory Affairs Manager
    Inion Oy
    Tampere, Finland

    Original Message


  • 3.  RE: GMDN code

    Posted 26-Feb-2016 07:40

    Dear Shaoying,

    FDA now requires you to have GMDN Code when populating your devices into the UDI Database (GUDID).

    ------------------------------
    Paul Boatner
    Sr Regulatory Affairs Specialist
    Zimmer Biomet CMF
    Jacksonville, FL

    Original Message


  • 4.  RE: GMDN code

    Posted 26-Feb-2016 09:16

    Dear Shaoying, 

    You are correct - not all countries require a GMDN code for medical device registration. 

    When you do need the code, you first submit a GMDN membership application. Membership gives you access to the GHDM database and includes access to a limited # of selected codes (you can purchase access to more as needed). You will receive instructions on how to search the database to find the most appropriate code for your product.  If there is no code that really fits, you are able to submit a proposal for a new code.

    ------------------------------
    Diane King RAC
    VP, Regulatory Affairs and Quality Assurance
    Gynesonics Inc.
    Redwood City CA
    United States

    Original Message


  • 5.  RE: GMDN code

    Posted 04-Oct-2018 10:30
    Per the UDI  Final Rule
    "...The GMDN Agency has agreed to provide free access to GMDN nomenclature within the context of the GUDID data submission process. A labeler who reports data to the GUDID will be able to enter a GMDN code if the labeler knows it, or may use a module integrated in the GUDID reporting system to search for and select an appropriate GMDN term. See § 830.310(b)(13)..."

    hope this is helpful
    ~Deb


    ------------------------------
    Deb Hervieux
    Compliance & Regulatory Affairs Engineer
    Foxboro MA
    United States
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    Original Message


  • 6.  RE: GMDN code

    Posted 05-Oct-2018 05:05
    Has anyone with GMDN access actually used the module in GUDID to see if this is adequate and matches to each other?

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message