Most companies still believe that Europe is the first market to enter for new medical devices. However, the regulatory pathway for Canadian device licensing is generally quicker and less expensive than the pathway for both the USA and Europe–especially for Class II devices. In fact, for a Class II device the entire process is typically completed in 30-45 days and the cost is $385 (CAN). In contrast, registration and listing in the USA is currently $3,382, and the cost of a 510(k) is equivalent to the cost of a Class III Canadian Device License Application (this is expected to change with fee increases in the USA for FY2018). The other advantage of a Canadian submission is that the Technical File content required for a Class III or Class IV submission can easily be repurposed for a European CE Marking submission. In this webinar you will learn:
- The different device classifications for Canada
- The submission requirements for each class
- The new electronic submission requirements for Health Canada’s license applications
- How to map an existing Technical File for CE Marking to Health Canada’s requirements
What you will receive for $49
- access to the live webinar (new Zoom platform)
- a recording of the webinar you can replay anytime (mp4 format)
- the native slide deck for this webinar (PPT format)
There will be approximately 50 slides during the presentation. The presentation will be approximately 60 minutes in duration, and you will have the opportunity to ask questions during the live webinar. Content will be sent via AWeber emails to confirmed subscribers.
Canadian Device Licensing Webinar ($49)
The Canadian Device Licensing Webinar will teach you how to prepare a Class II, III or IV device licensing application for Health Canada–including the new electronic submission process.
When is the Canadian Device Licensing Webinar?
On Wednesday, May 24 we will be hosting the Canadian Device Licensing Webinar live at 2:00pm EDT.
About Your Instructor
Mary Vater is a regulatory consultant with ~7 years experience in the medical device industry. She is a graduate of Wichita State University in Biomedical Engineering. Mary has both quality system and regulatory affairs experience with a variety of medical devices–including 510k submissions and CE Marking. Mary joined Medical Device Academy as a full-time employee in March 2017. She can be reached via phone (913) 274-9899 or email. You can also follow her on LinkedIn.