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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How Medical Devices are Classified in Canada Regulatory Classification Basics for your Medical Device: There are certain rules that apply
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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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