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United StatesHealth Canada Regulatory Requirements for Medical Devices
This course provides an overview of the Canadian Regulatory Framework for medical devices governed by Health Canada.
Whether you’re preparing licensing submissions, managing labelling and post-market surveillance responsibilities, or aligning with quality system expectations, this training equips you with the foundational knowledge required for Canadian compliance.
You’ll explore device classification, the Medical Device Licensing (MDL) process, Investigational Testing Authorizations (ITAs), labelling requirements, and post-market obligations. The course also highlights the Medical Device Single Audit Program (MDSAP), digital health considerations, and Canada’s role in international regulatory harmonization.
Our eLearning is a highly interactive way to learn at a time & a pace that works best for you, making it easier to get the training you need while balancing a busy home or work life.
Overview of our Health Canada Regulatory Requirements for Medical Devices
What's covered on our Health Canada Regulatory Requirements for Medical Devices Training
An interactive, engaging eLearning experience that you can complete Anytime, Anywhere.
Michelle Keane
Eoin Philip Kelly
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 eLearning course, each Learner will need to:
- Complete the eLearning course 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.
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