The processing cycle for Class III in vitro diagnostic medical devices (IVDs) Medical Device License (MDL) registration in Canada involves several stages, each with specific timelines. Here’s a general overview of the processing cycle:

1. Preparation Phase

• Timeframe: Several months to over a year (varies based on device complexity and readiness of documentation).
• Activities:
  • Confirm device classification.
  • Gather and prepare required documentation, including clinical evidence, risk management plans, quality management system documentation, labeling information, and manufacturing details.

2. Submission Phase

• Timeframe: Submission occurs after all materials are prepared.
• Activities:
  • Submit the MDL application through Health Canada’s eSubmissions portal or via paper submission.
  • Pay the applicable fees.

3. Review Phase

• Timeframe: Approximately 90 to 180 days (can vary based on the completeness of the application and the complexity of the device).
• Activities:
  • Health Canada reviews the application for completeness and compliance.
  • If additional information is required, Health Canada may issue queries, and you will need to respond promptly.

4. Decision Phase

• Timeframe: Following the review, a decision is typically made within a few weeks to a couple of months.
• Activities:
  • Health Canada issues a decision on the application.
  • If approved, a Medical Device License (MDL) is granted.
  • If denied, Health Canada will provide reasons for the denial, and you may have the option to appeal or reapply.

5. Post-Market Surveillance Phase

• Timeframe: Ongoing after receiving the MDL.
• Activities:
  • Comply with post-market obligations, including adverse event reporting and quality management.
  • Conduct regular reviews and updates as needed to ensure continued compliance.

Overall Timeline

• Total Processing Cycle: From initial preparation to receiving the MDL can range from approximately six months to over a year, depending on various factors such as documentation readiness, complexity of the device, and responsiveness to queries.

Additional Considerations

• Engagement with Regulatory Experts: To streamline the process, consider consulting with regulatory affairs professionals who can help ensure compliance and address potential issues early in the cycle.
• Anticipate Delays: Be prepared for possible delays, especially if additional information is requested during the review process.

By understanding the processing cycle, you can better plan your application strategy for Class III IVD MDL registration in Canada.

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