The process for registering a Class II in vitro diagnostic (IVD) medical device Medical Device License (MDL) in Canada involves several key steps. Here’s a detailed overview of the process:

Steps for Class II IVD MDL Registration

1. Determine Device Classification

• Confirm that the device is classified as Class II IVD according to Health Canada’s classification criteria. Understanding the classification will guide the regulatory requirements for your device.

2. Prepare Technical Documentation

• Collect and prepare the necessary technical documents, including:
  • Device description and specifications
  • Intended use and indications for use
  • Performance testing data (analytical and clinical validation)
  • Risk management documentation (ISO 14971)
  • Labeling and Instructions for Use (IFU)
  • Summary of safety and effectiveness data

3. Establish a Quality Management System (QMS)

• Implement and maintain a Quality Management System that complies with ISO 13485. This includes documenting processes related to design, manufacturing, and post-market activities.

4. Conduct Performance Testing

• Perform required analytical and clinical performance testing to demonstrate the device's safety and effectiveness. Document results thoroughly.

5. Complete the Application Form

• Fill out Form 3011 (Application for a Medical Device License). Ensure all sections are completed accurately, providing detailed information about the device and its intended use.

6. Submit Application to Health Canada

• Submit the completed application form along with all required technical documentation and any applicable fees through the Medical Device eSubmission System.

7. Health Canada Review

• Health Canada will review the application to ensure it meets regulatory requirements. This may involve:
  • Evaluating the technical documentation
  • Assessing the results of performance testing
  • Reviewing the labeling and instructions for use

8. Respond to Information Requests

• Be prepared to respond promptly to any requests from Health Canada for additional information or clarification during the review process.

9. Receive License Decision

• If the application is approved, you will receive the Medical Device License (MDL). If not approved, Health Canada will provide reasons for the decision, and you may need to address these issues before reapplying.

10. Post-Market Responsibilities

• Once licensed, implement post-market surveillance to monitor device performance, report adverse events, and maintain compliance with ongoing regulatory requirements.

11. Maintain Records

• Keep detailed records of all documentation, communications with Health Canada, and any changes made to the device or its processes.

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