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
... Read more August 6, 2025
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[blog_list]
The Role of Audits in Meeting Health Canada’s Compliance Standards
When it comes to audits related to Health Canada requirements, staying compliant is about more than checking off a list.
... Read more June 19, 2025
MDL vs. MDEL: Understanding Canada’s Medical Device Licensing
If you’re planning to sell or distribute a medical device in Canada, you’re going to hear two terms over and
... Read more May 21, 2025
How Manufacturers Can Stay Compliant With Canadian Medical Device Rules
https://youtu.be/E0E0dohMpC4 So, you’re a medical device manufacturer eyeing the Canadian market? Great choice! But before you dive in, let’s talk
... Read more October 18, 2023
What the Draft Guidance Means for MLMD Applications
*This summary of Health Canada’s guidance document provides compliance details for manufacturers submitting a new or amended application. Under the
... Read more 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
... Read more August 14, 2023
How to Get an MDEL License and Stay Compliant with Health Canada
Introduction Navigating Health Canada’s licensing requirements can feel overwhelming, especially when your business depends on compliance to operate. Many companies struggle to
... Read more 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
... Read more May 31, 2023
How to Get a Medical Device Establishment Licence in Canada
Learn how to get your Medical Device Establishment Licence faster and stay compliant with Health Canada.
... Read more May 29, 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
... Read more 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
... Read more March 20, 2023
MDEL, DEL, DIN & PRMA Application Fee Amendments for 2023
PMRA Annual Fees reduced for Reporting and Applications: Health Canada is implementing a new approach beginning April 1, 2023. The
... Read more March 7, 2023
Explore Health Canada’s 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
... Read more December 8, 2022
Understanding MDALL/MDEL & How It Transforms Your Business (MDL, MDALL, MDEL Listing)
Navigating medical device regulations set by Health Canada can be challenging. However, knowing the correct classification of your medical device
... Read more 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
... Read more 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
... Read more October 5, 2022
Your Health Canada eMCE Update For 2022
Manufacturers and companies exporting medical devices from Canada may be asked by foreign customers or foreign governments to supply certification
... Read more February 5, 2022
Cancellation of MDELs for Non-Compliance with Annual Licence Review Requirements
Cancellation of Medical Device Establishment Licence for A Non-compliance With Annual Licence Review Requirements On May 27, 2021 Health Canada
... Read more July 2, 2021
Interim Order No. 2 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19
As of March 1, 2021, Interim Order No. 2 replaces Interim Order No. 1 Respecting the importation and sale of
... Read more June 15, 2021
Ensuring Predictability for Interim Orders Relating to COVID-19
Health Canada recently published an additional notice regarding all interim orders relating to COVID-19 and Medical Devices. This notice is
... Read more December 15, 2020