How to Register Your Private Label Medical Device in Canada
Learn how to register a private label medical device with Health Canada. Follow this step-by-step guide to ensure regulatory compliance.
... Read more
August 6, 2025
[searchwp_form id=1]
[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
Learn what MDL and MDEL mean, how they differ, and how to stay compliant with Health Canada regulations.
... Read more
May 21, 2025
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.
... Read more
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What the Draft Guidance Means for MLMD Applications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.
... 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 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
... 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.
... Read more
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
... Read more
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
... 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’s notice on interim orders relating to COVID-19 and medical devices acknowledging stakeholders require predictability for regulatory aspects.
... Read more
December 15, 2020