Master Health Regulatory Affairs in Canada

About Course

Learn how to successfully register medical devices in Canada with confidence through this practical, industry-focused course designed around Health Canada medical device regulations.

This course provides a step-by-step guide to the complete Canadian medical device registration process, including device classification, licensing pathways, submission requirements, post-market compliance, vigilance systems, recalls, and regulatory maintenance.

Designed for Regulatory Affairs professionals, medical device manufacturers, importers, distributors, and healthcare business leaders, this course simplifies complex regulations into a clear, practical, and easy-to-follow learning experience.

Introduction to Health Canada and its regulatory framework
Health Canada Portal – understanding the online submission process
Medical Device Regulations in Canada – a full breakdown
Classification system and how to determine your device class
Step-by-step application and approval process
Renewals and variations – how to maintain your product on the market
Post-market surveillance & vigilance requirements
Latest updates, circulars, and best practices from Health Canada

Course Content

Module 1: Introduction to Health & Market Authority in Canada
Let's explore together Helath Canada

Introduction to Health & Market Authority in Canada

09:18

Module 2: The Regulations of Medical Devices Registration
In this section we will be introduced to our reference regulations of medical devices registration with Health Canada, we will build up our foundation towards the medical devices registration journey

Module 3: Classification
In this section we will step our first step towards the medical devices reposition journey with Health Canada, which is the classification

Module 4: The Core of Registration Process
In this section we will practice actuate registration process, this section is our core

Module 5: MDEL Application List
In this section we will practice the Medical Device Establishment Licensing Application process and List

Module 6: Conformity Assessment/ QMS
In this section we will practice the core certificates of any medical devices submission with any health authority , the quality compliance process via conformity assessment process and the QMS

Module 7: Canadian Nuclear Safety Commission
In this section we will have a look on Canadian Nuclear Safety Commission and its scope of activities and responsibilities

Module 8: Post-market Activities: Renewal, Variation & PV
In this section we will practice preregistration activities, the renewal and variations

Module 9: What is new?……Be Updated
In this closing section we will end up our journey with Health Canada for placing medical devices in the huge opportunistic market of Canada, we will take the challenge of being up to date

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Master Health Regulatory Affairs in Canada

About Course

What Will You Learn?

Course Content

Module 1: Introduction to Health & Market Authority in Canada
Let's explore together Helath Canada

Introduction to Health & Market Authority in Canada

Module 2: The Regulations of Medical Devices Registration
In this section we will be introduced to our reference regulations of medical devices registration with Health Canada, we will build up our foundation towards the medical devices registration journey

The Regulations

Module 3: Classification
In this section we will step our first step towards the medical devices reposition journey with Health Canada, which is the classification

Classification

Module 4: The Core of Registration Process
In this section we will practice actuate registration process, this section is our core

The registration Process

Module 5: MDEL Application List
In this section we will practice the Medical Device Establishment Licensing Application process and List

MDEL Application List

Module 6: Conformity Assessment/ QMS
In this section we will practice the core certificates of any medical devices submission with any health authority , the quality compliance process via conformity assessment process and the QMS

Conformity Assessment/ QMS

Module 7: Canadian Nuclear Safety Commission
In this section we will have a look on Canadian Nuclear Safety Commission and its scope of activities and responsibilities

Canadian Nuclear Safety Commission

Module 8: Post-market Activities: Renewal, Variation & PV
In this section we will practice preregistration activities, the renewal and variations

Renewal/variation

Module 9: What is new?……Be Updated
In this closing section we will end up our journey with Health Canada for placing medical devices in the huge opportunistic market of Canada, we will take the challenge of being up to date

What is new?

Final

Earn a certificate

About Course

What Will You Learn?

Course Content

Module 1: Introduction to Health & Market Authority in Canada Let's explore together Helath Canada

Introduction to Health & Market Authority in Canada

Module 2: The Regulations of Medical Devices Registration In this section we will be introduced to our reference regulations of medical devices registration with Health Canada, we will build up our foundation towards the medical devices registration journey

The Regulations

Module 3: Classification In this section we will step our first step towards the medical devices reposition journey with Health Canada, which is the classification

Classification

Module 4: The Core of Registration Process In this section we will practice actuate registration process, this section is our core

The registration Process

Module 5: MDEL Application List In this section we will practice the Medical Device Establishment Licensing Application process and List

MDEL Application List

Module 6: Conformity Assessment/ QMS In this section we will practice the core certificates of any medical devices submission with any health authority , the quality compliance process via conformity assessment process and the QMS

Conformity Assessment/ QMS

Module 7: Canadian Nuclear Safety Commission In this section we will have a look on Canadian Nuclear Safety Commission and its scope of activities and responsibilities

Canadian Nuclear Safety Commission

Module 8: Post-market Activities: Renewal, Variation & PV In this section we will practice preregistration activities, the renewal and variations

Renewal/variation

Module 9: What is new?……Be Updated In this closing section we will end up our journey with Health Canada for placing medical devices in the huge opportunistic market of Canada, we will take the challenge of being up to date

What is new?

Final

Earn a certificate

Student Ratings & Reviews

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Module 1: Introduction to Health & Market Authority in Canada
Let's explore together Helath Canada

Module 2: The Regulations of Medical Devices Registration
In this section we will be introduced to our reference regulations of medical devices registration with Health Canada, we will build up our foundation towards the medical devices registration journey

Module 3: Classification
In this section we will step our first step towards the medical devices reposition journey with Health Canada, which is the classification

Module 4: The Core of Registration Process
In this section we will practice actuate registration process, this section is our core

Module 5: MDEL Application List
In this section we will practice the Medical Device Establishment Licensing Application process and List

Module 6: Conformity Assessment/ QMS
In this section we will practice the core certificates of any medical devices submission with any health authority , the quality compliance process via conformity assessment process and the QMS

Module 7: Canadian Nuclear Safety Commission
In this section we will have a look on Canadian Nuclear Safety Commission and its scope of activities and responsibilities

Module 8: Post-market Activities: Renewal, Variation & PV
In this section we will practice preregistration activities, the renewal and variations

Module 9: What is new?……Be Updated
In this closing section we will end up our journey with Health Canada for placing medical devices in the huge opportunistic market of Canada, we will take the challenge of being up to date