The processing cycle for a Class II in vitro diagnostic (IVD) medical device Medical Device License (MDL) registration in Canada typically involves several stages, from preparation to approval. Here’s a detailed overview of the processing cycle:

1. Preparation Stage (Variable Duration)

• Duration: Several weeks to a few months, depending on the complexity of the device and the readiness of documentation.
• Activities:
  • Confirm device classification as Class II IVD.
  • Gather and prepare all required documentation, including:
    • Completed Form 3011
    • Quality Management System (QMS) certification (ISO 13485 and MDSAP)
    • Device description and specifications
    • Evidence of safety and effectiveness (performance testing and validation data)
    • Labeling and Instructions for Use (IFU)
    • Payment of application fees
• Tip: Ensuring thorough preparation can significantly reduce processing time later.

2. Submission Stage (1-2 Days)

• Duration: Immediate upon submission.
• Activities:
  • Submit the application electronically through the Medical Device eSubmission System (MDEL Portal) or by mail (if necessary).
  • Confirm that all required documents and fees are included in the submission.

3. Initial Review by Health Canada (Approx. 10-15 Days)

• Duration: About 10 to 15 calendar days.
• Activities:
  • Health Canada conducts an initial review to verify that the application is complete and that all required documents have been submitted.
  • If the application is incomplete or requires additional information, Health Canada may contact the applicant for clarification or missing documentation.
• Tip: Responding promptly to any requests for additional information can help keep the review process on track.

4. Technical Review by Health Canada (Approx. 30-45 Days)

• Duration: Approximately 30 to 45 calendar days, following the initial review.
• Activities:
  • A detailed technical review is conducted by Health Canada to assess the safety, effectiveness, and quality of the device based on the submitted documentation.
  • Reviewers evaluate the performance data, risk assessments, and compliance with applicable standards and regulations.
• Tip: During this stage, it’s important to be available to respond to any questions or additional information requests from Health Canada.

5. Final Decision and Approval (Approx. 5-10 Days)

• Duration: About 5 to 10 calendar days after the technical review.
• Activities:
  • If the application meets all requirements, Health Canada will issue the Medical Device License (MDL), allowing the device to be marketed in Canada.
  • If the application is not approved, Health Canada will provide reasons for the decision, and the applicant may have the opportunity to address the concerns or appeal the decision.
• Tip: Ensure that all aspects of the device are compliant with Canadian regulations to maximize the chances of approval.

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