Health Canada Regulatory Requirements for Medical Devices

At the end of this short course, successful learners will be able to:

• Understand Health Canada’s medical device regulatory framework, including classification and licensing
• Identify the requirements for Medical Device Licenses (MDL) and Investigational Testing Authorization (ITA)
• Apply Canadian rules for labelling, bilingual requirements, and establishment licensing
• Recognize post-market surveillance and compliance requirements, including recalls and incident reporting
• Navigate MDSAP, digital health regulations, and Health Canada’s involvement in international regulatory collaboration

This course is for individuals or organizations who want to understand Health Canada Regulatory Requirements for Medical Devices.

Successful completion of the course examination will entitle each Learner to receive a digital Certificate of Completion.

In order to successfully complete this course, each Learner will need to:

• Complete all eLearning modules and obtain 70% or higher in the final assessment (MCQ-based)

There are recommended requirements for each Learner in wishing to complete any of our eLearning modules. In our experience, Workplace IT environments’ internal configurations and available software can vary (new or old), and there may be various limitations or other restrictions in place, and as such, the functionality of any Learning Management System (LMS) may be impacted, restricted and may not perform well. Read the full technology requirements here.