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.
What is MDL?
MDL stands for Medical Device Licence. This licence is issued by Health Canada to manufacturers of Class II, III, and IV medical devices. It gives formal authorization to sell those products in the Canadian market.
To apply for an MDL, manufacturers must submit a detailed application that includes evidence related to safety, efficacy, and quality. This might involve clinical data, product testing results, and manufacturing process documentation. Health Canada reviews this information to ensure the device meets applicable standards before granting approval.
Device classes are assigned based on risk. Class I devices pose the lowest risk and don’t require an MDL. Class II devices (e.g. contact lenses), Class III devices (e.g. ventilators), and Class IV devices (e.g. pacemakers) each require progressively more rigorous oversight.
Once an MDL is issued, the manufacturer is expected to monitor post-market performance, report any incidents, and apply for amendments if the product is modified.
What is MDEL?
MDEL stands for Medical Device Establishment Licence. While the MDL is about the product, the MDEL is about the business handling that product. It applies to importers and distributors of medical devices, regardless of class.
An MDEL shows that your business follows proper protocols for complaint handling, product recalls, storage, distribution, and recordkeeping. It’s designed to ensure that even if a company isn’t the manufacturer, it still has systems in place to protect end users.
Unlike the MDL, which only needs to be updated when product details change, the MDEL must be renewed annually. Health Canada may conduct inspections to assess whether your quality management system and compliance practices are in place and functioning.
Even if you deal only in Class I devices, like simple thermometers or bandages, you still need an MDEL if you’re importing or distributing them in Canada.
Why both licences matter
MDL and MDEL are distinct but connected. Health Canada requires that anyone involved in the medical device supply chain is traceable and accountable. This means that both the product itself and the company handling it must be reviewed and authorized.
Failing to hold the correct licence can result in delays at customs, rejection of products, or more serious enforcement actions. For example, a foreign manufacturer trying to ship Class III devices into Canada without an MDL will not be allowed to sell.
Similarly, a Canadian importer without an MDEL may face seizure of goods or facility inspection warnings.
Key differences between MDL and MDEL
MDL (Medical Device Licence) | MDEL (Medical Device Establishment Licence) |
Required for Class II, III, IV devices | Required for importers and distributors |
Applies to the product | Applies to the business |
Requires safety and quality documentation | Requires operational compliance procedures |
Valid unless cancelled or amended | Must be renewed annually |
Reviewed by the Medical Devices Directorate | Overseen by Health Canada’s ROEB |
Do you need both?
Some companies only need one of the two. For example, a Class I device distributor in Canada only needs an MDEL. A foreign manufacturer of a Class III device only needs an MDL. But many companies need both.
Let’s say you manufacture a Class II diagnostic device overseas and plan to import and sell it in Canada through your local office. You would need:
- An MDL for the device itself
- An MDEL for your Canadian establishment
This scenario is common for global companies with regional offices. It’s also relevant to Canadian manufacturers that manage their own distribution in-house.
Staying compliant year-round
Holding the correct licence is not enough. You must maintain your compliance through proper documentation, training, and reporting practices. Here are some best practices:
- Keep records of all sales, complaints, and distribution for at least five years
- Maintain clear procedures for recalls and customer feedback
- Ensure your staff are trained on Health Canada requirements
- Report incidents or changes in business operations promptly
- Submit your MDEL renewal application before the deadline each year
Health Canada publishes inspection summaries and issues warning letters when businesses fail to comply. Staying organized and proactive can help you avoid those outcomes.
Where to get help
The application process for MDL and MDEL can be complex, especially if you’re new to the Canadian market or working with limited internal resources. That’s where third-party regulatory consultants like Quality Smart Solutions can make a big difference.
We’ve helped hundreds of companies prepare, submit, and maintain their medical device licences. Our team knows how to navigate the forms, gather the right documentation, and respond to regulatory questions.
Contact us to get expert guidance or request a consultation. You can also visit Health Canada’s Medical Devices page for official resources and application guidelines.
Disclaimer: This content is for informational purposes only and does not constitute legal or regulatory advice.
