If you’re planning to sell or distribute a medical device in Canada, you’re going to hear two terms over and over again: MDL and MDEL. Understanding the difference between them is one of the first steps toward compliance with Health Canada’s medical device regulations.

The two licences cover different parts of the process. One applies to the product itself, the other to your business. And if you get them mixed up or apply too late, you could face delays, inspection issues, or even enforcement actions.

In this guide, you’ll learn what MDL and MDEL mean, how they apply to your operations, and how to meet Health Canada’s requirements. Whether you’re a new entrant to the Canadian market or looking to stay on track during annual renewals, this is a resource you can come back to.