The timeframe for obtaining a Class III in vitro diagnostic medical devices (IVDs) Medical Device License (MDL) in Canada and the details of the review process vary based on several factors, including the complexity of the device and the completeness of the submission. Here’s an outline of the typical timeline and the review process:

Typical Timeline for Class III MDL Registration

1. Application Preparation Time

   • Preparing the application, gathering all technical documentation, and ensuring compliance with regulatory requirements can take several weeks to a few months, depending on the readiness of the data and documentation.

2. Health Canada Review Time

   • The Health Canada review process for a Class III MDL application generally takes 60 to 75 days (around 2–3 months) if the submission is complete and all requirements are met.

3. Overall Timeline

   • From preparation to final approval, the entire process can take anywhere from 4 to 6 months or longer, depending on any additional information requests or the need for supplementary documentation.

Review Process for Class III MDL Registration

The review process for a Class III MDL application includes several stages:

1. Administrative Screening

   • Initial Review: Health Canada first conducts an administrative screening to ensure all required documents and information are included. If there are missing items or incomplete sections, Health Canada may request additional information before proceeding to the substantive review.

2. Substantive Scientific Review

   • This in-depth review includes a thorough examination of the device's safety, effectiveness, and quality. Key elements reviewed include:
     • Device Description: An assessment of the technical specifications, intended use, and unique features of the device.
     • Clinical Evidence: Evaluation of clinical data supporting the safety and effectiveness of the device, including studies or trials relevant to Canadian populations.
     • Risk Management Documentation: Review of risk management processes per ISO 14971, including identification and mitigation of potential risks.
     • Quality Management System (QMS): Confirmation that the manufacturer’s QMS complies with ISO 13485 standards.
     • Labeling and Instructions for Use: Verification that labeling meets regulatory requirements, including clarity and accuracy of instructions for use.
     • Manufacturing Information: Assessment of the manufacturing processes and quality control measures to ensure consistent product quality.

3. Requests for Additional Information

   • Clarifications and Data Requests: During the substantive review, Health Canada may request additional information or clarification on certain aspects of the application, such as clinical data, risk assessment details, or manufacturing controls. Responding to these requests promptly can help keep the application process on track.

4. Final Decision and Notification

   • Approval or Denial: Once the review is complete, Health Canada will issue a decision:
     • Approval: An MDL is granted, allowing the device to be marketed in Canada.
     • Denial: If denied, Health Canada will provide reasons, and the manufacturer may have the opportunity to address the issues and reapply or appeal.

5. Post-Market Surveillance Obligations

   • After approval, the manufacturer must implement post-market surveillance, including adverse event reporting and regular performance assessments, to ensure ongoing compliance with Health Canada regulations.

Additional Considerations

• Responding to Health Canada Promptly: Quick and accurate responses to any requests for additional information can help expedite the review.
• Regulatory Expertise: Working with regulatory affairs professionals can help streamline the application preparation and submission process.

By understanding these timelines and the review steps, applicants can better plan for the MDL registration process and maintain efficient communication with Health Canada throughout the process.

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