medical device licensing Canada

02

Sep

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What You Need to Know About Health Canada’s Medical Device Classifications and Licensing

Whether you are an established medical device manufacturer or entering the Canadian market for the first time, determining the correct classification is the essential first step in licensing your product. An incorrect classification can lead to costly errors, regulatory delays, and extended time to market, ultimately resulting in lost revenue.…

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31

Jul

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Avoid Delays: How to Successfully License a Medical Device in Canada

When entering the Canadian market, medical device manufacturers face a complex regulatory system designed to safeguard patient safety and public health. Central to this framework is the classification of devices into classes I to IV, based on risk. This walk-through explains how Health Canada’s regulatory environment works, outlines each device…

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