Medical Devices Regulatory Submissions
Health Canada has adopted a risk-based classification system which is consistent with that of other countries.
Canadian medical device risk-classifications are based on the application of the risk classification rules outlined in the Medical Devices Regulations.
It is important to note that a product may have a different risk rating in Canada than assigned in other regulatory jurisdictions.
It is also important to note that some products regulated as medical devices in other countries, may in fact be drugs or natural health products in Canada, based on the definitions that are found in the Food and Drugs Act (FDA).
Our team of Regulatory Consultants are trained in risk classifications and planning a regulatory strategy that will help ensure a successful and compliant product launch.