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Session 5: Plenary Session: Innovation of Medical Devices: Challenges to Scale Up but With Opportunities to Grab
Session Chair(s)
Rania Mouchantaf, PhD
A/Executive Director, Marketed Pharmaceuticals Bureau, MHPD
Health Canada, Canada
The last eighteen months were very dynamic for devices in Canada, Europe, US, and worldwide. This session will present what has been seen to date and will consider what may be yet to come as we explore both the challenges and opportunities in the area of medical device regulation. Various perspectives will be shared which will include regulatory, industry, and the patient. In turn, the session will provide attendees with an understanding of the recent activities surrounding medical devices in Canada including updates to the regulations as they pertain to medical device classification and the corresponding regulatory requirements and pathways to market authorization.
Learning Objective : At the conclusion of the session, the participants:- Understand the current and future directions as they relate to medical device regulations in Canada
- Recongize the role of patient engagement in supporting regulatory decisions for medical devices
Speaker(s)
Challenges and Opportunities in Premarket Evaluation of Medical Devices
David Boudreau
Health Canada, Canada
Director General, Medical Devices Directorate, Health Products and Food Branch
Innovation and Regulation: Challenges and Opportunities
Diana Johnson
Medtech Canada, Canada
VP Regulatory Affairs
Patient Needs and Demands for Medical Devices
Kimberley Hanson, MBA
Diabetes Canada, Canada
Executive Director, Federal Affairs
Panelist
Patrick Fandja, MBA, MS
Health Canada, Canada
Director, Bureau of Biologics, Radiopharmaceuticals and Self-care products
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