Medical Devices Regulatory Submissions

Health Canada uses 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).

Once the appropriate submission type is determined, DSA can prepare and file the application on your behalf.  Applications are filed through the Common Electronic Submissions Gateway (CESG) through our validated CESG account.

Our services include filing of:

• Class II, III and IV license applications
• Single Device License Applications
• Medical Device Families
• Medical Device Groups
• Medical Device Group Families
• Medical Device Systems and Test Kits
• Amendment Applications
• Minor Change Applications
• Private Label Applications
• Annual Reports
• Medical Device Establishment License (MDEL) Applications

Our team of Regulatory Consultants will prepare a regulatory strategy that includes  risk classifications and label reviews to help ensure a successful and compliant product launch.