Applying for Class III in vitro diagnostic medical devices (IVDs) in Canada involves several steps:

1. Determine Classification: Confirm that your device is classified as Class III. This usually involves a risk assessment based on Health Canada’s classification rules.

2. Prepare a Device License Application (MDL): You’ll need to prepare an application that includes detailed information about your device, such as:

   • Device description
   • Intended use
   • Labeling information
   • Summary of safety and effectiveness
   • Risk management information

3. Gather Supporting Documentation: You may need to provide:

   • Clinical data or evidence demonstrating the device's safety and effectiveness
   • Quality management system documentation (e.g., ISO 13485 certification)
   • Information on manufacturing processes

4. Submit the Application: Submit your application through Health Canada's online system (eSubmissions) or by mail, along with the applicable fees. Ensure all documents are complete and meet the regulatory requirements.

5. Respond to Health Canada Queries: After submission, Health Canada may request additional information or clarification. Respond promptly to these queries to avoid delays.

6. Receive License Decision: Once Health Canada reviews your application and is satisfied with the information provided, they will issue a Medical Device License (MDL).

7. Post-Market Surveillance: After your device is licensed, you must comply with post-market requirements, including adverse event reporting and quality management.

For the most accurate and up-to-date information, refer to the Health Canada website or consult with a regulatory affairs expert.

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