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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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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Manufacturers and companies exporting medical devices from Canada may be asked by foreign customers or foreign governments to supply certification
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As a Canadian medical device license (MDL) holder, you are subject to an annual license renewal procedure. The renewal process
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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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On June 28, 2021, Health Canada opened a public consultation on a Unique Device Identification (UDI) system for medical devices
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Who Needs an MDSAP Certificate? Anyone looking to manufacture a Class II, III or IV medical device in Canada requires
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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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As of March 1, 2021, Interim Order No. 2 replaces Interim Order No. 1 Respecting the importation and sale of
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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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Earlier this summer, Health Canada provided a notice to industry on the regulatory considerations for non-medical masks or face coverings,
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Health Canada is not only the national regulatory authority for issuing health product marketing authorizations, but it also oversees and
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