The cycle for Class II in vitro diagnostic (IVD) medical device Medical Device License (MDL) registration in Canada can vary based on several factors, but here's a general timeline breakdown:

1. Preparation Phase

• Duration: Several weeks to several months.
• Activities: Gathering documentation, conducting performance testing, and establishing a Quality Management System (QMS). The time required will depend on the complexity of the device and the completeness of the data.

2. Submission Phase

• Duration: Immediate upon completion of the application.
• Activities: Once the application is ready, submit it through the Medical Device eSubmission System.

3. Health Canada Review Phase

• Duration: Typically 60 to 120 days, but it can extend longer.
• Activities:
  • Initial Screening: 30 days for completeness checks.
  • Detailed Review: Health Canada evaluates technical documentation, performance data, and compliance with regulatory standards.
  • Information Requests: If additional information is needed, the review period may be extended.

4. Post-Decision Phase

• Duration: Ongoing.
• Activities: After receiving the MDL, manufacturers must implement post-market surveillance and maintain compliance, which is an ongoing responsibility.

Total Cycle Time

• The overall cycle from preparation to receiving a decision can range from a few months to over a year, depending on the specifics of the application and any additional information requests from Health Canada.