Webinar Description:
Selling, importing, or distributing medical devices in Canada requires a clear understanding of Health Canada’s regulatory framework. This session will guide you through the essentials of Medical Device Licensing (MDL) and Medical Device Establishment Licensing (MDEL), from determining if your product qualifies as a medical device to navigating classification rules, licensable activities, and inspection readiness.
- Through practical examples and a real-world case study, you’ll learn how to:
- Classify medical devices using Health Canada’s risk-based system
- Understand when an MDL or MDEL is required—and who is exempt
- Prepare for and maintain compliance during Health Canada inspections
- Implement effective quality management systems for ongoing success
Whether you’re a manufacturer, importer, or distributor, this webinar will provide the tools, insights, and strategies you need to achieve regulatory compliance and bring your medical device to market efficiently.
About the Speaker:
Shirley Furesz is the Director, Regulatory Affairs Medical Devices at Innomar Strategies Inc. She has been working as a regulatory affairs consultant since 2006 and has extensive experience with medical devices, in vitro diagnostics, companion diagnostics and combination products including those used in orthopedics, cardiology, gastroenterology, general surgery, dermatology, gynecology, imaging, respiratory, ENT, urology, wound care, dentistry, infection control, and oncology.
Shirley received her Ph.D. in the area of vaccine development from the Department of Veterinary Immunology and Microbiology at the University of Guelph. She provides regulatory strategy and manages a wide range of device submissions for Health Canada and other regulatory agencies. Shirley achieved her Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society in 2009.
Prior to joining Innomar Strategies, she was a key member of the medical devices consulting team at Icon plc (previously Mapi Life Sciences, OptumInsight and CanReg Inc.) and has held various research positions at Syn-X Pharma and NoAb BioDiscoveries Inc. in the areas of Point of Care Diagnostic Kit development, Proteomics, Cell Biology, and ADME-Tox testing.
Have Questions?
Be part of the conversation. Submit your questions in advance to info@diac.ca by September 16, 2025. Please use the subject line "Question for Mastering Medical Device Compliance".
Registration Fee:
Free for DIAC members | $99 for non-members (fee credited if you join DIAC).
Registration Deadline:
Closes at 1:00 PM on September 22, 2025.
