Health Canada medical device labelling guidelines are designed to ensure the device’s use is clearly understood by users. These guidelines help patients and practitioners use the device as intended. Hence, the medical device labelling guidelines have a role in device...
Health Canada issues two types of licenses, medical device establishment licence (MDEL) and medical device licence (MDL). Medical devices are categorised into Class I, II, III, and IV, based on risk level. It is important to determine the class to which your medical...
If you are planning to sell medical devices in Canada, you will be required to mandatorily secure an approval. Navigating the Health Canada medical device regulations can be a cumbersome task. We have listed some of the mistakes encountered while securing the Health...