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  • 1.  Current timeline for Health Canada review of an Investigational Testing Authorization (ITA)?

    Posted 23-May-2022 09:07
    Hello,

    Does anyone have recent experience with Health Canada review of an ITA for a Class II-III device? Approximately how long is it taking from submission to approval? Are they keeping to the theoretical 30 days? I am trying to set the right expectations with the project team. Thanks in advance!

    PS: Any experience with issues or challenges with recent applications that we should keep an eye for is also greatly appreciated.

    Lucas

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    Lucas Fernandez
    Director, Medical Devices Compliance
    Broomfield CO
    United States
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  • 2.  RE: Current timeline for Health Canada review of an Investigational Testing Authorization (ITA)?

    Posted 24-May-2022 06:12
    Hi Lucas, 

    I am currently working on an ITA for a Class II device. The screening process was speedy, still waiting for the approval to come through. We are well within the 30 day timeline at this point.

    Hope this helps.

    ------------------------------
    Richie Christian
    Head of Quality and Regulatory
    Auckland
    New Zealand
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  • 3.  RE: Current timeline for Health Canada review of an Investigational Testing Authorization (ITA)?

    Posted 25-May-2022 09:33

    Hi Lucas,

     

    From my experience, they are staying very close to the full 30 calendar days to review an ITA application to "first decision".  This means that usually on day 28 or 29 you receive an additional information request (or if you are lucky, the authorization letter).  If you are submitting an amendment to an existing ITA, you are more likely to get the authorization letter with no questions, but if it is a new ITA application it is very rare that they don't ask questions.  On occasion for a Class II ITA there may be no questions, but for a Class III/IV there are always questions and if you are building timelines for a study, I'd account for this.  If you do receive questions, you have 60 days to respond, however if you have the answers right away, you can respond the next day if you wish (you don't need to take the full 60 days).  Once the response is submitted then the 30 calendar day starts again and the reviewer will most likely take the full 30 days to respond with hopefully the authorization and no further questions.

     

    Hope this helps!

     

    Shirley

     

    Shirley Furesz, Ph.D., RAC

    Amerisource Bergen

    TPIreg, Innomar Strategies

    Director Regulatory Affairs, Medical Devices

     

    Cell phone: 519-242-6476

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