FDA 510(k) pre-submissions vs PMA: What’s the difference?
When preparing to launch a medical device in the U.S., one of the first and most important decisions
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June 23, 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
April 2025 Updates to Medical Device Shortage Reporting
Medical device shortage reporting requirements have recently changed, and it is essential for manufacturers and importers to stay informed.
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April 29, 2025
What Is MDSAP and Why Does It Matter?
Learn how MDSAP helps meet Health Canada requirements and streamline audits for medical device compliance.
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April 3, 2025
Avoid FDA Medical Device Submission Errors With These Tips
Avoid FDA medical device submission errors and improve your approval chances with these expert tips.
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March 18, 2025
Understanding FDA FURLS, FDA Approved, and FDA Registered Medical Devices
This article explores the differences between these designations and provides insights into how to obtain the necessary licenses for medical devices.
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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
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
Class 2 Medical Devices: Unlocking compliance requirements
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
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
The ultimate regulatory guide to importing products into Canada
https://youtu.be/mWaBQzsa1_M If you’re a business owner looking to expand your reach into the Canadian market, importing products may be a
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May 17, 2023
FDA Furls: How do they affect medical device manufacturers?
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
5 Essential Tips for Choosing a Quality Import Service
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
Understanding the regulations 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
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
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
