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  • 1.  Health Canada -MDALL Class II Approval Timing

    Posted 27-May-2020 08:51
    Anyone have recent experience filing a new application for a Class II Medical Device License with Health Canada? I'm trying to estimate how long it will take for HC to review & approve.

    Thanks!

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    Joshua Lust
    Senior Quality & Regulatory Affairs Manager
    Grand Rapids MI
    United States
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  • 2.  RE: Health Canada -MDALL Class II Approval Timing

    Posted 27-May-2020 16:17
    https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/policies/management-applications-medical-device-guidance-2019/document.html#a26

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    Shilpa Pillai
    Naperville IL
    United States
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    Original Message


  • 3.  RE: Health Canada -MDALL Class II Approval Timing

    Posted 28-May-2020 08:09
    Thank you for the link to the guidance Shilpa.

    Anyone have recent experience with filing a Class II MDALL to know if HC is close to their target review time?

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    Joshua Lust
    Senior Quality & Regulatory Affairs Manager
    Grand Rapids MI
    United States
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    Original Message


  • 4.  RE: Health Canada -MDALL Class II Approval Timing

    Posted 28-May-2020 08:24
    Hi Joshua, 
    My most recent experience with Class II filings was back in 2018. I can tell you that HC was very much within their target review time. Depending on the complexity of the device, a decision could be made within a couple of weeks.


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    Karen Zhou
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    Original Message


  • 5.  RE: Health Canada -MDALL Class II Approval Timing

    Posted 29-May-2020 08:24
    Hi Joshua,

    I filed a new Class II Medical Device License application for a single cardiovascular device in Canada a few weeks ago and they were very responsive, clearing it within two weeks.  It's an N of 1 but based on that they're following the stated timelines in the guidance.

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    Brian Young
    VP, Regulatory and Clinical Affairs
    Health Policy Associates, Inc.
    Boerne TX
    United States
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    Original Message


  • 6.  RE: Health Canada -MDALL Class II Approval Timing

    Posted 01-Jun-2020 07:44
    Thanks to everyone for their guidance on HC Class II approval times!

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    Joshua Lust
    Senior Quality & Regulatory Affairs Manager
    Grand Rapids MI
    United States
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    Original Message


  • 7.  RE: Health Canada -MDALL Class II Approval Timing

    Posted 01-Jun-2020 12:04
    Hi Joshua,

    I've done several Class II licenses recently and I agree with the other members - they're very quick to review and issue licenses, provided the application is complete.  In my experience, the applications are reviewed and approved within their performance target timeframes (around 15 days).

    One spot where I've seen hangups occur is in section 16 of the license application - review documents (labelling).  They mention the "device label" in the application form but per their guidance on labelling (https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-labelling-medical-devices-including-vitro-diagnostic-devices-appendices.html) this also includes the instructions for use (unless self-evident to the user), and they have a section in there for electronic labelling if applicable. 

    Hope this helps,
    Brittany


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    Brittany Gibson BSc
    Director, Quality and Regulatory Affairs
    Winnipeg MB
    Canada
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    Original Message


  • 8.  RE: Health Canada -MDALL Class II Approval Timing

    Posted 02-Jun-2020 09:03
    That's great - thanks for the watch out Brittany!

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    Joshua Lust
    Senior Quality & Regulatory Affairs Manager
    Grand Rapids MI
    United States
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    Original Message


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