We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. Privacy Policy.
A practical roadmap to Health Canada's device classes, MDL and MDEL requirements, and the path to market for manufacturers, importers, and distributors. Fill out the form, and we'll send the guide directly to your inbox.
Every medical device sold in Canada falls into one of four risk-based classes and that classification determines which licences you need before you can bring it to market. Getting this step wrong early on can mean delays, rework, or applying for the wrong licence entirely.
This guide walks you through Health Canada's four device classes, the difference between an MDL and an MDEL, and the decision path for manufacturing, importation, or distribution. It also covers software as a medical device, licence renewal timing, and answers to the questions companies ask most often.
This guide is for manufacturers, importers, and distributors who are bringing a medical device to the Canadian market for the first time, or reassessing classification for an existing product line.
Since 2007, our team has guided 3,500+ companies across 74 countries through medical device classification and licensing with Health Canada, alongside 60,000+ regulatory projects across other product categories. If you'd like to talk through your device's classification directly, reach out to our team.