The Learning Portal will be under maintenance Monday, 6 December between 6 AM and 5 PM EST. Portal functionality will be unavailable during this window.
We apologize for any inconvenience caused during this time.

Medical Devices: Canadian Regulations [3.0 RAC]

3.0 RAC Credits Online Course, Medical Device Certificate Elective     Member: $365.00 Nonmember: $500.00


Medical Devices: Canadian Regulations [3.0 RAC]

Member Price: $365.00

List Price: $500.00

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
  • Formats: Web and Tablet

Learning Objectives

Upon completion of this course, participants should be able to:

  • 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
Enrollment Period: 6 months