How Audits Help You Stay Compliant with Health Canada
When it comes to audits related to Health Canada requirements, staying compliant is about more than checking off a list.
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June 19, 2025
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[blog_list]
How to Navigate MDL and MDEL Licensing in Canada
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
Medical Device Compliance in Canada: A Guide for Manufacturers
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
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October 18, 2023
Inside Scoop: Draft Guidance for MLMD Application Submissions
*This summary of Health Canada’s guidance document provides compliance details for manufacturers submitting a new or amended application. Under the
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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
6 steps to earn your Medical Device Establishment License (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
Why your business should have a trusted Medical Device Importer?
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
The ultimate guide to obtaining a Medical Device Establishment Licence
https://youtu.be/mtmJgcfh9gI If you are planning to, import, distribute, or sell medical devices in Canada or manufacture Class I medical
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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
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March 22, 2023
MDEL & MDL Approval: How much will your MDL cost in 2023?
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
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.
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March 7, 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
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
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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
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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
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June 15, 2021
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
