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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*This summary of Health Canada’s guidance document provides compliance details for manufacturers submitting a new or amended application. Under the
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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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In this blog, we discuss the benefits, challenges, steps, and opportunities a medical device establishment license can offer manufacturers and
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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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Introduction: Manufacturing and selling medical devices in Canada can be a complex process and requires adherence to Health Canada’s
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The price for an MDEL (Medical Device Establishment Licence) and MDL (Medical Device Licence) in Canada varies according to the
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PMRA Annual Fees reduced for Reporting and Applications: Health Canada is implementing a new approach beginning April 1, 2023.
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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 Medical Device License is a legal document required to manufacture, sell, and distribute medical devices. The Medical Device
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The Medical Device License is a legal document that is required for the manufacture, sale, and distribution of medical
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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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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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