How To Register Your Private Label Medical Device In Canada

How To Register Your Private Label Medical Device In Canada
Andrew Parshad
President & Founder of Quality Smart Solutions

In This Article:

Step-by-step guide for registering a private label medical device with Health 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. 

FAQs

Do I need a device licence if the original manufacturer is already licensed?

No, but you must submit a private label application with Health Canada and ensure the original manufacturer provides a letter of authorization. 

No. Even for Class I devices, you need an MDEL if you’re importing or distributing in Canada. 

You risk Health Canada enforcement, including stop-sales, recalls, or monetary penalties. Unregistered products cannot legally be sold. 

It can be, especially if you’re new to the process. That’s why many companies choose to work with regulatory consultants to reduce risk and save time. 

Yes. Quality Smart Solutions helps brands navigate every step of private label registration, MDEL applications, and licensing support. 

Get help with your private label medical device registration 

Registering a private label medical device in Canada involves several important steps, and it’s not always easy to know where to begin. Understanding what’s required, such as whether you need a Medical Device Licence (MDL), a Medical Device Establishment Licence (MDEL), or must meet specific criteria for SaMD (software as a medical device), can help you plan more effectively and avoid unnecessary delays. 

Our team at Quality Smart Solutions offers regulatory support to guide you through these decisions. Whether you’re preparing documentation, navigating licensing forms, or clarifying your obligations under Health Canada’s rules, we’re here to help you stay on track. 

If you’re looking for support or need help understanding your next step, contact us or explore our full medical device regulatory services. 

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Andrew Parshad
Andrew Parshad is President, CEO and founder of Quality Smart Solutions, a North American compliance solutions provider offering regulatory and quality assurance services to comply with FDA & Health Canada brands and ingredients regulations in the categories of dietary supplements, foods, cosmetics, OTC drugs and medical devices. Andrew started Quality Smart Solutions in 2007. Since that time he and his firm has served thousands of clients worldwide . Andrew's affiliate company, Quality IMPORT Solutions that offers import agent services into the Canadian market as a government licensed importer for foods, dietary supplements and medical devices.
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