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  • 1.  Health Canada Medical Device License Amendment

    This message was posted by a user wishing to remain anonymous
    Posted 24-Jun-2022 09:54
    This message was posted by a user wishing to remain anonymous

    Hello, 

    For a class II Medical Device License amendment to Health Canada, is it possible to include multiple class II product licenses in one amendment if the changes are similar or do we need to submit separate amendment by license?

    Thank you!


  • 2.  RE: Health Canada Medical Device License Amendment

    Posted 27-Jun-2022 09:57

    Hi Anon,

     

    Unfortunately, you will have to amend each licence separately.  You can indicate in the cover letter or in the email that you are submitting a number of licence amendments with the same changes so that when they are received they all get reviewed together and not sent to different people.  Hopefully this will speed up the process.

     

    Hope this helps,


    Shirley

     

    Shirley Furesz, Ph.D., RAC

    Amerisource Bergen

    TPIreg, Innomar Strategies

    Director Regulatory Affairs, Medical Devices

     

    Cell phone: 519-242-6476

    Fax: 888-887-8686

     

    Vacation Alert: Out of office Friday July 1, 2022, Happy Canada Day!

     

    3470 Superior Court

    Oakville ON L6L0C4

    Canada

    www.innomar-strategies.com

     

    United in our responsibility

    to create healthier futures

     




    Original Message


  • 3.  RE: Health Canada Medical Device License Amendment

    This message was posted by a user wishing to remain anonymous
    Posted 29-Jun-2022 09:58
    This message was posted by a user wishing to remain anonymous

    Hi Shirley,

    Thank you for your response!

    Is it the same scenario even for manufacturer's address change license amendment - Minor change form? 

    The minor change amendment form requests a copy of page 1 of the applicable license (s).


    Original Message


  • 4.  RE: Health Canada Medical Device License Amendment

    Posted 29-Jun-2022 10:08
    Hello Anon,

    Yes, it is the same for faxback/non-significant amendments as well unfortunately.  This is because HC assigns a separate application number for each amendment and creates a file in their document system, so if they are bundled, they have to split it all up.

    Hope this helps!

    Shirley 

    Shirley Furesz, Ph.D., RAC

    Amerisource Bergen

    TPIreg, Innomar Strategies

    Director Regulatory Affairs, Medical Devices

     

    Cell phone: 519-242-6476

    Fax: 888-887-8686

    www.innomar-strategies.com

     

    United in our responsibility to create healthier futures





    Original Message


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