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  • 1.  Medical Devices_Australia_post approval changes_ stock depletion

    Posted 28-Jan-2020 11:08
    Dear All
    Does anybody know how long do I have to depletion the stock in Australia?
    I mean, when you have an approved change what is the maximum time to finish the previous version? is it regulated?
    Thank you in advance
    Kind regards


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    Fabiola Patino
    Regulatory Affairs Specialist

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  • 2.  RE: Medical Devices_Australia_post approval changes_ stock depletion

    This message was posted by a user wishing to remain anonymous
    Posted 29-Jan-2020 08:53
    This message was posted by a user wishing to remain anonymous

    Hi Fabiola,

    Answer to your question will depend on the following -
    • What route was taken to gain ARTG entry?
    • What is the change?
    • When was the stock imported into Australia i.e. after or before the change was implemented?



  • 3.  RE: Medical Devices_Australia_post approval changes_ stock depletion

    Posted 29-Jan-2020 15:04
    Hi, 

    Thank you, I see do you know if there is a rule, instructions, regulation or any that could help me to know it?
    an example could be: "a change in specification of an MD class III, and the stock was imported before the change was implemented"

    Best regards

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    Fabiola Patino
    Pharmaceutical Chemist
    Noche Buena
    Mexico
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