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.
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August 6, 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
A Clear Guide to FDA 510(k) Submission Requirements
Introduction In the world of medical devices, ensuring patient safety and efficacy is paramount. The 510(k) submission process is a
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September 28, 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
Decoding the Jargon: Medical Device approvals 510(K) V.S. PMA differences & process
Are you a medical professional or someone involved in the healthcare industry? If so, you’ve likely come across the
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July 20, 2023
The Importance of Amazon Seller Compliance: How to Avoid Penalties and Boost Sales
In today’s competitive marketplace, selling products on Amazon has become a lucrative opportunity for many entrepreneurs and businesses. However, navigating
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June 21, 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
A Guide to Health Canada Compliance for Health Businesses
In the ever-evolving healthcare landscape, staying up-to-date with the latest regulations and requirements is crucial for health professionals. And when
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June 15, 2023
The Ultimate PMA Submissions Guide: The Importance of Proper Documentation
Proper documentation is essential in any business operation and is particularly crucial when it comes to PMA submissions. Preparing and
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June 13, 2023
FDA guidance for EUA medical devices transition under PHE policies
The U.S. Food and Drug Administration (FDA) published two final guidelines on March 24, 2023, to help manufacturers of medical devices transition
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June 13, 2023
How to Meet Compliance Standards for Class II Medical Devices
Medical devices play a crucial role in modern healthcare, providing patients with life-changing treatments and improving the quality of
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June 1, 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 Manufacturers Can Register With the FDA
Are you running a business that deals with food, drugs, medical devices, cosmetics, or dietary supplements? If so, you must
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May 25, 2023
Everything You Need to Know About Importing Products Into Canada
If you’re a business owner looking to expand your reach into the Canadian market, importing products may be a viable
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May 17, 2023
Software as Medical Devices SaMD Registration Everything you should know
As technology continues to advance, the use of Software as Medical Devices (SaMD) is becoming more prevalent in the
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April 13, 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
Health Canada Medical Device License Renewals (MDL or MDEL) in 2023
As a Canadian medical device license (MDL) holder, you are subject to an annual license renewal procedure. The renewal process
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March 22, 2023
Understanding Class I Medical Devices Approval With Health Canada
What are Class 1 Medical Devices? Class 1 medical devices are the lowest risk category of medical devices, as they
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March 8, 2023
Clearing Regulatory Hurdles with a 510K Premarket Notification
Submitting a 510K Premarket Notification is an essential step in the process of getting medical devices approved by the
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January 23, 2023
Top 10 Fruitful Medical Device Development Principles
Regulatory agencies across the globe, including the U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s Medicines
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February 9, 2022
Public Consultation on Medical Devices Unique Device Identifier Initiative
On June 28, 2021, Health Canada opened a public consultation on a Unique Device Identification (UDI) system for medical devices
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September 14, 2021
Public Consultation on Medical Devices Clinical Trials Modernization Initiative
Health Canada has published a consultation paper on proposed changes to the regulation and oversight of clinical trials for drug,
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July 16, 2021
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
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