The time it takes to obtain a Class II in vitro diagnostic (IVD) medical device Medical Device License (MDL) in Canada typically varies based on several factors, but here’s a general breakdown:

1. Preparation Phase

• Duration: Several weeks to several months.
• This phase involves gathering all necessary documentation, conducting performance testing, and establishing a compliant Quality Management System (QMS).

2. Health Canada Review Phase

• Duration: Generally 60 to 120 days.
• The review process includes:
  • Initial Screening: Health Canada conducts a completeness check, which can take about 30 days.
  • Detailed Technical Review: A thorough evaluation of the submitted documentation and performance data follows, which can take an additional 30 to 90 days.

3. Response to Information Requests

• If Health Canada requests additional information or clarification during the review process, this may extend the timeline. The duration depends on how quickly the manufacturer can provide the requested information.

Total Estimated Timeline

• Overall Duration: From preparation to receiving a decision, the entire process can take anywhere from a few months to over a year, depending on the complexity of the application and the efficiency of the preparation and review phases.

Summary

• Preparation Phase: Several weeks to months.
• Health Canada Review: Typically 60 to 120 days.
• Total: A few months to over a year, influenced by various factors.

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