MDL vs. MDEL in Canada: Which License Do You Need?

The Golden Rule

The difference primarily depends on who you are and what class the device is.

1. Medical Device License (MDL)

This is for the Product. It is required for manufacturers of Class II, III, and IV devices. If you are the legal manufacturer, you need an MDL for each device family.

2. Medical Device Establishment License (MDEL)

This is for the Company (The Activity). It is required for:

• Importers and Distributors of all classes.
• Manufacturers of Class I devices.

The "Cross-Over" Trap

Many US manufacturers try to sell Class II devices in Canada directly. You cannot sell without an MDL. If you use a distributor, they need an MDEL, and you need an MDL.