Introduction The process of bringing a medical device to market in the United States involves stringent regulations imposed by the
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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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As a business owner operating in dietary supplements and health products, you are undoubtedly aware of the ever-evolving regulatory
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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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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 medical device manufacturer, getting your product to market can be a complex process with various regulatory requirements to
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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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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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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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Looking for a quality import service can be a daunting task, but with the right advice and tips, you can
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Introduction: Class 3 medical devices are subject to the highest level of scrutiny and require special attention when it comes
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Introduction: Medical devices are an important part of healthcare and play a critical role in the treatment of patients.
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Navigating the medical device regulations set by Health Canada can be a complicated task, but knowing the specific classification
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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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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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On December 11, 2021, Health Canada issued a notice regarding the annual adjustment of fees for drugs and medical devices
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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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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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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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As of March 1, 2021, Interim Order No. 2 replaces Interim Order No. 1 Respecting the importation and sale of
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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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