The time it takes to obtain Class III in vitro diagnostic medical device (IVD) Medical Device License (MDL) registration in Canada can vary significantly based on several factors, including the complexity of the device and the completeness of the application. Here's a general timeline breakdown:

Typical Timeline for MDL Registration

1. Preparation Phase:

   • Documentation and Application Preparation: This phase can take several weeks to several months depending on how quickly the manufacturer can gather the necessary technical, clinical, and regulatory documentation. This includes compiling clinical evidence, risk management documentation, quality management system information, and labeling.

2. Submission Phase:

   • Application Submission: Once the application is complete and submitted (either electronically through Health Canada’s eSubmissions portal or via paper submission), the processing officially begins.

3. Review Phase:

   • Health Canada Review Time: The actual review process by Health Canada typically takes around 60 to 75 days (approximately 2–3 months) for Class III MDL applications if the submission is complete and all necessary information is provided.
   • Additional Information Requests: If Health Canada requires more information or clarification during the review, this can extend the timeline. Manufacturers must respond promptly to any requests to avoid delays.

4. Final Decision Phase:

   • Decision Notification: After the review is complete, Health Canada will issue a decision. If approved, a Medical Device License (MDL) will be granted. If denied, Health Canada will provide reasons for the denial, which may lead to further review or reapplication.

Overall Timeline

• Total Time from Start to Finish: Considering preparation, submission, and review, the entire process can take anywhere from 4 to 6 months or longer, especially if additional information is needed or if there are any delays in the review process.

Conclusion

While the review phase itself may be relatively quick, the overall duration to obtain MDL registration for a Class III IVD can be influenced by the thoroughness of the initial application, the complexity of the device, and how promptly the manufacturer addresses any additional requests from Health Canada. Manufacturers should plan accordingly and ensure all documentation is complete to help facilitate a smooth and timely review process.