What is a Medical Device?
The definition of a medical device under Canada's Food and Drugs Act and what falls within the scope of Health Canada regulation.
What is NOT a Medical Device?
Products that are not regulated as medical devices under Canada's Food and Drugs Act and Medical Devices Regulations.
Regulatory Framework Overview
An overview of Canada's medical device regulatory framework, key legislation, and the role of Health Canada's Medical Devices Directorate.
Who Needs to Comply?
The different parties regulated under Canada's Medical Devices Regulations — manufacturers, importers, distributors, and others.
Lifecycle of a Medical Device
The full regulatory lifecycle of a medical device in Canada, from concept through to market withdrawal.
Glossary of Key Terms
Definitions of key terms used in Canadian medical device regulation under the Food and Drugs Act and Medical Devices Regulations.