FDA Removes Key Barrier to Real-World Evidence for Drugs and Medical Devices
The U.S. Food and Drug Administration has announced a change to how it evaluates real world evidence in regulatory reviews. In
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December 17, 2025
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[blog_list]
Preparing Instructions for Use for FDA Submission
Preparing Instructions for Use (IFUs) for FDA Submission for Medical Devices Preparing Instructions for Use for FDA submission can feel
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September 26, 2025
Comparing FDA 510(k) and PMA Pathways for Medical Devices
When preparing to launch a medical device in the U.S., one of the first and most important decisions you’ll make
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June 23, 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
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May 21, 2025
Health Canada’s April 2025 Updates on the Medical Device Shortage List
Medical device shortage reporting requirements have recently changed, and it is essential for manufacturers and importers to stay informed. On
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April 29, 2025
Understanding the Importance of MDSAP Certification
If you’re working in the medical device space and looking to expand into the Canadian market, here’s a question for
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April 3, 2025
Your Guide to Submitting a Medical Device to the FDA Without Errors
Submitting a medical device to the FDA can feel like navigating a maze. Even the most seasoned teams can overlook
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March 18, 2025
Understanding FDA FURLS, FDA Approved, and FDA Registered Medical Devices
The process of bringing medical devices to market in the United States involves stringent regulations imposed by the Food
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November 2, 2023
Navigating the Regulatory Seas: How Experts Ensure Your Medical Devices Set Sail Smoothly
Introduction In the ever-changing world of medical device manufacturing, ensuring your product complies with regulations is akin to navigating stormy
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September 29, 2023
Why is it crucial to avoid FDA Warning Letters for dietary supplements and health products?
As a business owner operating in dietary supplements and health products, you are undoubtedly aware of the ever-evolving regulatory
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September 27, 2023
Health Canada MDALL Medical Device Registration Guide
Introduction Health Canada MDALL is the key to legally marketing medical devices in Canada. If you are a manufacturer looking
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August 1, 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
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June 19, 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 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.
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May 29, 2023
A complete guide to 510k submissions: Everything you should know
As a medical device manufacturer, getting your product to market can be a complex process with various regulatory requirements to
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May 23, 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
Understanding FDA Furls and Their Impact on Medical Device Companies
https://youtu.be/yvnTszySkgg If you’re in the medical device manufacturing business, you’re likely familiar with the FDA’s regulations, including FDA Furls. However,
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April 25, 2023
FDA Registration Renewals: FDA Increases Facility Enforcement
As a business owner, keeping up with regulatory requirements is a top priority. One such requirement is the FDA’s renewal
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March 22, 2023
How to Choose the Right Importer: 5 Essential Tips
Looking for a quality import service can be a daunting task, but with the right advice and tips, you can
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March 13, 2023
5 Tips to Find the Best Medical Device Regulatory Consultant
Finding the right medical device regulatory consultant is one of the most important steps to ensure your product meets all
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February 15, 2023
How to Navigate Regulatory Requirements for Class III Medical Devices
Introduction: Class 3 medical devices are subject to the highest level of scrutiny and require special attention when it comes
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February 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
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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
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November 16, 2022
Inside Scoop FDA Medical Device User Fees (MDUFA) for 2023
The FDA or U.S. Food and Drug Administration recently announced the Fiscal Year Medical Device User Fee (MDUFA) amendments. The
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November 1, 2022
EUA FDA Transition Plan for Medical Devices in 2022
In response to the COVID-19 public health emergency, FDA issued a declaration regarding the appropriateness of utilizing emergency use authorizations
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April 29, 2022
Health Canada’s Annual Adjustment of Fees for Drugs & Medical Devices
On December 11, 2021, Health Canada issued a notice regarding the annual adjustment of fees for drugs and medical devices
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March 11, 2022
Interim Order No. 3 The Sale of Medical Devices for COVID-19 use
Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 (the third interim
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March 8, 2022
What You Need to Know – Software as a Medical Device (SaMD)
The advancement of technology is rapidly progressing, and the evolution can be observed all around us. As cutting-edge technology becomes
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October 28, 2021
US Establishment Registration Renewals
It’s that time of year again! Any domestic and foreign establishments registered with US FDA must renew their registration annually
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October 11, 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
Health Canada expedites access to COVID-19 diagnostic laboratory test kits and other medical devices
Recently in Canada, the Minister of Health has signed an Interim Order to allow expedited access to COVID-19-related medical devices
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April 15, 2020