Medical Devices: Canadian Regulations
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
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
This course is also included in:
