Successful Medical Device Registration in Canada
Registering medical devices in Canada is a crucial step toward gaining access to one of North America’s most important healthcare markets.
Canada has a well-structured but strictly regulated approval system overseen by Health Canada. Successful registration enables
- Class I:Low risk – no license required, but manufacturer registration is mandatory
- Class II: Moderate risk – license required; basic technical documentation and compliance with ISO 13485 are necessary
- Class III:High risk – extensive technical data and clinical evidencerequired
- Class IV: Highest risk – strict clinical data requirements and comprehensive safety evidence are necessary
For Class II, III, and IV medical devices, a valid MDSAP certificate is a prerequisite for approval by Health Canada.
International manufacturers must designate a Canadian licensed importer or distributor who is responsible for communicating with Health Canada. For many products, proof of a certified quality management system in accordance with ISO 13485 (MDSAP) is mandatory.
What Sets Our Seminar Apart
In this interactive seminar, you’ll learn about the regulatory requirements for the approval of medical devices in Canada.
We’ll walk you through the process step by step, showing you how to correctly classify your products, prepare the necessary documentation, compile clinical evidence, and successfully complete the approval process with Health Canada.
- Content
- Overview of Canadian medical device regulations (Medical Devices Regulations)
- Structure and responsibilities of Health Canada and the MDD
- Risk classification (Class I–IV) and its impact on the approval process
- Clinical evidence requirements in Canada
- Quality management requirements (ISO 13485)
- Selection and role of a Canadian importer/distributor
- Timeline, fees, and common pitfalls in the approval process
- Your Benefits
- You will understand Health Canada’s regulatory framework and processes.
- You will be able to correctly classify your products and choose the appropriate regulatory strategy.
- You will know what clinical and technical evidence is required.
- You will receive practical tips to help speed up the regulatory approval process.
- Methods
Instructor-led sessions, group exercises, facilitated case studies, practical exercises, individual work, real-world case studies, discussions, live coaching, storytelling.
- Target Audience
- Regulatory Affairs (RA) professionals
- Quality Management (QM) professionals
- Developers and manufacturers of medical devices
- Project managers in the medical technology sector
- Exporters of medical devices
