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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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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Using a medical device import agent can offer several benefits, especially if you are navigating the complex process of
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Are you a medical device manufacturer looking to enter the Canadian market? Navigating the regulatory landscape can be overwhelming,
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Are you a medical professional or someone involved in the healthcare industry? If so, you’ve likely come across the
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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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In this blog, we discuss the benefits, challenges, steps, and opportunities a medical device establishment license can offer manufacturers and
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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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Proper documentation is essential in any business operation and is particularly crucial when it comes to PMA submissions. Preparing and
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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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Medical devices play a crucial role in modern healthcare, providing patients with life-changing treatments and improving the quality of
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As a business owner in the medical industry, you understand the importance of providing quality products and services to your
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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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Are you running a business that deals with food, drugs, medical devices, cosmetics, or dietary supplements? If so, you must
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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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As technology continues to advance, the use of Software as Medical Devices (SaMD) is becoming more prevalent in the
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Introduction: Manufacturing and selling medical devices in Canada can be a complex process and requires adherence to Health Canada’s
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What are Class 1 Medical Devices? Class 1 medical devices are the lowest risk category of medical devices, as
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Submitting a 510K Premarket Notification is an essential step in the process of getting medical devices approved by the
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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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On June 28, 2021, Health Canada opened a public consultation on a Unique Device Identification (UDI) system for medical devices
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Health Canada has published a consultation paper on proposed changes to the regulation and oversight of clinical trials for drug,
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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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Health Canada recently published an additional notice regarding all interim orders relating to COVID-19 and Medical Devices. This notice is
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