MDL vs. MDEL: Understanding Canada’s Medical Device Licensing
Learn what MDL and MDEL mean, how they differ, and how to stay compliant with Health Canada regulations.
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May 21, 2025
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[blog_list]
How Manufacturers Can Stay Compliant With Canadian Medical Device Rules
Discover how regulatory consultants help medical device manufacturers thrive in Canada’s complex compliance landscape: real-life insights.
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October 18, 2023
What the Draft Guidance Means for MLMD Applications
Discover the secrets behind successful Machine Learning-Enabled Medical Device (MLMD) development, risk management, and more.
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September 11, 2023
Benefits & requirements of using a medical device MDEL Import Agent
Using a medical device import agent can offer several benefits, especially if you are navigating the complex process of
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August 14, 2023
How Businesses Can Secure a Medical Device Establishment Licence (MDEL)
In this blog, we discuss the benefits, challenges, steps, and opportunities a medical device establishment license can offer manufacturers and
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June 19, 2023
How a Trusted Importer of Record Supports Medical Device Compliance
As a business owner in the medical industry, you understand the importance of providing quality products and services to your
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May 31, 2023
How to comply with Health Canada Regulations for Medical Devices?
Introduction: Manufacturing and selling medical devices in Canada can be a complex process and requires adherence to Health Canada’s
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March 22, 2023
Understanding the Costs of MDL and MDEL Approvals
The price for an MDEL (Medical Device Establishment Licence) and MDL (Medical Device Licence) in Canada varies according to the
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March 20, 2023
Health Canada Medical Device Regulations (MDL, MDEL, SaMD)
Introduction: Medical devices are an important part of healthcare and play a critical role in the treatment of patients. Medical
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December 8, 2022
Understanding MDALL/MDEL & How It Transforms Your Business (MDL, MDALL, MDEL Listing)
Navigating the medical device regulations set by Health Canada can be a complicated task, but knowing the specific classification
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November 16, 2022
Medical Device License (MDL MDEL SaMD) Under the Microscope
The Medical Device License is a legal document required to manufacture, sell, and distribute medical devices. The Medical Device Licence
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November 15, 2022
Inside Scoop MDL VS MDEL & SAMD: Medical Device License Unlocked
The Medical Device License is a legal document that is required for the manufacture, sale, and distribution of medical
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October 5, 2022
Ensuring Predictability for Interim Orders Relating to COVID-19
Health Canada’s notice on interim orders relating to COVID-19 and medical devices acknowledging stakeholders require predictability for regulatory aspects.
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December 15, 2020