Efficient Market Entry: Health Canada Regulatory Pathways for Class II–IV Medical Devices

Entering the Canadian medical device market requires a deep understanding of Health Canada’s regulatory requirements. This video from Freyr Solutions outlines clear, actionable strategies for manufacturers of Class II, III, and IV medical devices to achieve efficient and compliant market entry.

Learn how to:

• Accurately classify your medical device under Health Canada’s risk-based system
• Prepare a complete Medical Device Licence (MDL) submission package
• Ensure MDSAP audit readiness for quality compliance
• Streamline documentation and minimize review timelines through strategic planning
• Leverage expert regulatory support to avoid delays and ensure first-time submission success

With Freyr’s proven expertise in Health Canada regulatory affairs, global MedTech innovators can accelerate their device approvals and bring innovations to the Canadian market faster, safely, and confidently.