Global Medical Device Regulatory Requirements – Canada (2 hours)

This two-hour course provides a comprehensive overview of medical device regulatory requirements including the regulatory framework, pre- and post-market requirements, and the way Canada is utilizing MDSAP.

Key learning objectives:

By the end of this course, you will be able to:

• Identify the regulatory framework for medical devices
• Determine the correct classification for medical devices
• Understand how Canada utilizes the Medical Device Single Audit Program (MDSAP)
• Understand the pre-market pathway and requirements for medical devices
• Understand the quality management system regulations required to market a medical device in Canada
• Understand the post-market requirements for medical devices in Canada

This course is essential for anyone wanting to bring a medical device or IVD to market in Canada, and also for employees in R&D, regulatory, quality and compliance functions.