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...
Health Canada reviews medical devices for safety, effectiveness, and quality before authorizing them for sale in Canada. Canada has a stringent medical device regulatory system, as it prioritises patient safety and effective healthcare delivery. If you are planning to...
Medical devices have an indispensable role in the healthcare industry. They need to be strictly monitored and regulated for safety, efficacy, and quality to deliver high quality healthcare to patients. Their regulation plays a vital role in safeguarding the healthcare...
The Canadian medical device industry is evolving and dynamic with considerable growth potential. Entrepreneurs are showing growing interest to enter the Canadian medical device market. We have prepared this guide to help you easily register medical devices in Canada....