How to register your private label medical device in Canada

Planning to sell a medical device under your brand in Canada? You might assume that using a licensed manufacturer means you’re automatically covered. But is that actually true? 

The short answer is no. If your brand name appears on the label, Health Canada considers you the responsible party. That means you’re expected to meet all the same requirements a manufacturer or distributor must follow, including registering your private label medical device and obtaining the right licences. 

If you’re unsure what that involves or worried about missing something, this guide will walk you through the essentials. We’ll show you the steps to take, the common mistakes to avoid, and how to move forward with clarity and confidence. Keep reading to learn more. 

What is a private label medical device? 

A private label medical device is a product that’s manufactured by one company and then sold under a different brand name, usually yours. While you don’t make the device yourself, you are still held responsible for how it’s marketed and distributed in Canada. 

This is where it can get confusing. You may think the manufacturer’s licence is enough, but Health Canada sees your brand on the label and expects you to meet specific obligations. These include ensuring the device is properly licensed (if it falls under Class II, III, or IV) and holding a valid Medical Device Establishment Licence (MDEL) if you’re importing or distributing the product. 

Understanding this distinction is key. Without the right documentation and registration in place, your product could be pulled from the market or flagged for non-compliance. That’s why it’s essential to know your role as the private labeler and what steps are required to stay compliant. 

Who needs to register a private label medical device? 

If you plan to sell or distribute a medical device under your brand in Canada, you must ensure: 

• The original manufacturer holds the correct Health Canada medical device licence (Class II, III, or IV). 
• You hold an MDEL if you’re importing or distributing the product. 

Private labelers are not exempt from Health Canada’s regulations. Even if the manufacturer is licensed, your business still needs to register appropriately. 

Step-by-step: Private label medical device registration 

1. Determine the device class

Health Canada categorizes medical devices from Class I (lowest risk) to Class IV (highest risk). This classification affects licensing requirements. Use Health Canada’s risk-based classification guidance to confirm your device class. 

2. Confirm manufacturer licensing

For Class II to IV devices, the original manufacturer must have an active Medical Device Licence (MDL). As a private labeler, you must obtain a letter of authorization from the manufacturer, allowing you to register the product under your brand. 

3. Apply for an MDEL

If you’re importing or distributing the device in Canada, you’ll need a valid Medical Device Establishment Licence. This involves submitting an application through Health Canada, providing detailed business information, and ensuring your QMS (quality management system) is compliant. 

4. Submit private label application

If your private label product is Class II, III, or IV, you must submit a private label licence application to Health Canada.  

This includes the following: a completed licence application form; evidence of authorization from the original licence holder; and a product labeling reflecting your brand. 

5. Prepare your labelling and documentation

Labels must meet Health Canada’s labelling requirements and show your company’s name as the brand owner. Ensure all instructions, warnings, and symbols are properly displayed.