Medical devices are regulated by Health Canada under the Food and Drugs Act and the Medical Devices Regulations (MDR). Under the MDR all devices must meet safety and effectiveness requirements and must have a compliant label before they can be imported into and/or sold in Canada. In Canada, medical devices are regulated using a lifecycle approach. Health Canada uses a risk-based classification system that assigns medical devices to one of four classes, with Class I being the lowest risk and Class IV being the highest risk.
This course will provide a basic understanding of medical device regulations in Canada. It will address a wide range of issues 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 of devices, selection of the appropriate license type, submission requirements, quality systems and postmarket requirements.
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
Target Audience
This program is designed for new regulatory professionals and others in related departments interested in understanding the basics of the regulation of medical devices in Canada.