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  • 1.  Health Canada Interim Order 3 - transition Period

    This message was posted by a user wishing to remain anonymous
    Posted 27-Jun-2022 09:00
    This message was posted by a user wishing to remain anonymous

    Hi Everyone, 
    If you have a medical device that was submitted to HC via Interim order, I hope you are able to answer the following question:

    Once the IO expires (and under the assumption  HC will not issue  IO 4 ) will manufacturers have a transition period to obtain the applicable license (MDAL in our case)? 


    MTA!


  • 2.  RE: Health Canada Interim Order 3 - transition Period

    Posted 02-Jul-2022 19:50
    Hi Anon

    There are plans in discussion for some kind of transition, aiming to prevent interruptions in supply: 

    https://www.canada.ca/en/health-canada/corporate/about-health-canada/legislation-guidelines/acts-regulations/forward-regulatory-plan/plan/regulatory-proposal-transition-interim-order-respecting-importation-sale-medical-devices.html

    Not sure which licence type you may need. MDEL is pretty straightforward. MDL will take more planning.

    ------------------------------
    Anne LeBlanc
    United States
    ------------------------------

    Original Message


  • 3.  RE: Health Canada Interim Order 3 - transition Period

    Posted 04-Jul-2022 09:10

    Hi Anon,

     

    Health Canada published a notice regarding the intent to amend the Medical Devices Regulations to import and sell COVID-19 medical devices and it was open for consultation in May.  See link here.  Consultation on amendments to regulations to import and sell COVID-19 medical devices - Canada.ca.

     

    The actual notice can be found here Notice: Proposed changes to the Medical Devices Regulations to continue the importation and sale of COVID-19 medical devices - Canada.ca.  There has been nothing published since the consultation has ended as to what the final route will be, but it will likely look a lot like this proposal.

     

    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

     

    3470 Superior Court

    Oakville ON L6L0C4

    Canada

    www.innomar-strategies.com

     

    United in our responsibility

    to create healthier futures

     




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