Risk Assessment & Product Registrations

Canada has adopted a risk-based classification system which is consistent with that of other countries. Canadian risk-classifications are based on the application of the risk classification rules outlined in the Regulations. It is important to note that a product may have a different risk rating in Canada than it has been assigned in other countries.

Low risk devices such as toothbrushes, surgical instruments, and collection bags are classified as Risk I. Blood Pressure Monitors, Digital Thermometers, and Pregnancy Test Kits are classified as Risk 2. Higher risk devices such as dental or breast implants, prosthetics, and drug test kits are classified as Risk 3. Highest risk devices such as artificial hearts, heart pacemakers, skin grafts, and cardiovascular stents are classified as Risk IV.

DSA will review your product to determine risk classification for the Canadian market.

All risk II, III, and IV medical devices must be registered with Health Canada prior to their sale in Canada. DSA Consultants will handle all aspects of submission preparation, review and on-going contact with the Medical Devices Bureau to follow through on product approvals. We can spearhead the entire registration project or just handle specific components of the submission process for you, such as a QC Review of submissions prepared by your own staff.

DSA Consultants can handle the following types of submissions to Health Canada’s Medical Devices Bureau:

• Risk Class II
• Risk Class III
• Risk Class IV
• License Amendments
• Private Label Medical Devices
• Private Label Medical Device License Amendments
• Investigational Testing Authorizations
• Changes to the Name of Licensed Devices
• Changes to Manufacturer Name/Address
• Non-Significant additions or deletions

Contact us today to find out how we can help you spearhead your registration projects. For more information on services offered, click here to request a copy of our free brochure.

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