Workshop Overview
This webinar provides a structured overview of the regulatory pathway for bringing medical devices to market in Canada. Attendees will gain an understanding of how medical devices are regulated under Health Canada’s Medical Devices Regulations and how risk-based classification influences regulatory requirements.
The session will walk through key elements of the Canadian regulatory framework, including device classification, licensing pathways, and regulatory considerations for market authorization. The session provides participants with sufficient foundational knowledge to begin navigating the regulatory process for marketing medical devices in Canada.
Drawing from hands-on, real-time real industry perspectives, the session will also discuss how regulatory decisions are made in practice and how regulatory strategy supports successful market entry and ongoing product lifecycle management.
Who Should Attend
This session is designed for regulatory affairs professionals, industry practitioners, and students seeking a practical understanding of how medical devices are regulated and brought to market in Canada.
Workshop Outline
This workshop covers the following topics:
- Introduction to Medical Device Regulation in Canada
- Overview of Health Canada’s regulatory framework
- Definition of a medical device under Canadian regulations
- Risk-Based Classification of Medical Devices
- Medical device classes (Class I–IV)
- Factors influencing device classification
- Practical examples illustrating classification strategies
- Regulatory Pathway to Market Authorization
- Licensing requirements for medical devices
- Overview of submission pathways
- Key documentation considerations
- Regulatory Strategy and Industry Considerations
- Interpreting regulatory requirements in real-world practice
- Common challenges in regulatory submissions
- Post-Market Responsibilities
- Compliance and ongoing regulatory obligations
- Product lifecycle management
- Questions and Discussion
Attendees Will Gain an Understanding Of
- Explain the risk-based classification system for medical devices in Canada
- Identify regulatory pathways for obtaining medical device market authorization
- Understand key elements of the Medical Device Licence (MDL) process
- Recognize post-market regulatory responsibilities for medical devices
- Understand how regulatory strategy supports market entry and product lifecycle
All participants will receive a certificate of attendance upon completion of the workshop.
