Medical Devices: Canadian Regulations

This course will provide a basic understanding of medical device regulations in Canada.

This course will provide a basic understanding of medical device regulations in Canada. It will address a wide range of compliance requirements, from the regulatory framework provided by Health Canada and the steps to submit an investigational testing application or a medical device licence application to postmarket activities. You will learn the classification rules applied to devices, selection of the appropriate licence type, submission requirements, quality systems and postmarket requirements.

At a Glance

Target Audience: This course is designed for new professionals in regulatory and related departments interested in understanding the basics of medical device regulation in Canada.

Learning Level: Basic

Total Length of Course: 3 Hours

RAC Points: 3

Medical Device Certificate Elective

Enrollment Period: 12 months

Learning Objectives

Discuss the regulatory framework for medical devices in Canada

Evaluate the appropriate classification of medical devices

Identify the regulatory requirements for an Investigational Testing Authorization (ITA), a Medical Device License (MDL) and a Medical Device Establishment License (MDEL)

Discuss the requirements for quality systems for medical devices

Explain the Medical Device Inspection Programme

Lesson Titles

Lesson 1: Regulatory Framework

Lesson 2: Classification

Lesson 3: Premarket Requirements

Lesson 4: Quality Systems

Lesson 5: Postmarket Activities

This course is also included in: