Regulatory Open Forum

 View Only
  • 1.  Introduction

    Posted 12 days ago

    Hello,

    My name is Deep Meriya. I am currently pursuing my masters in regulatory affairs at Northeastern University in Toronto, Canada. I would like to get insights of how regulatory bodies work in canada.



    ------------------------------
    Deep Meriya
    Northeastern University, Toronto, Ontario, Canada
    Oshawa ON
    Canada
    ------------------------------


  • 2.  RE: Introduction

    Posted 12 days ago

    Welcome, Deep

    You might begin by looking through the Health Canada website. There's lots of stuff there, some parts of which will probably interest you more than others.

    https://www.canada.ca/en/health-canada/corporate/about-health-canada.html



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



  • 3.  RE: Introduction

    Posted 11 days ago

    Hello Deep,

    I've worked on several medical device license applications in Canada (IVD medical devices) and have found communications with Health Canada to be straightforward and efficient.  They've been very responsive to questions as well.  I second Health Canada's website as a resource.  In addition to the Medical Devices Regulations, there are numerous guidance documents that provide more detail essential to compliance with the regulations.  Sometimes the web of guidance docs can be a little tricky to navigate but there is a lot of good information in them.

    https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents.html

    https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents.html



    ------------------------------
    Jennifer Rowan
    Regulatory Affairs Specialist
    Microbiologics
    Saint Cloud MN
    United States
    ------------------------------