The timeline for the Class I in vitro diagnostic (IVD) medical device MDL (Medical Device License) registration in Canada is generally shorter compared to higher-risk devices, as Class I devices are subject to a more streamlined process. However, the actual time required can depend on several factors, such as the completeness of your application and whether any additional documentation or clarifications are requested by Health Canada.

Typical Timeline for Class I IVD MDL Registration:

1. Preparation and Document Collection:

   • Time Needed: 1 to 4 weeks (depending on the completeness of your documentation and labeling).
   • Before submitting the application, you need to gather all the required materials, including the device description, labeling (in both English and French), instructions for use (IFU), and quality management documentation. Preparing these materials in both languages (English and French) can take additional time.

2. Account Creation on Health Canada's MDE Online Portal:

   • Time Needed: 1 to 2 days.
   • If you have not done so previously, you will need to create an account on Health Canada's MDE Online Portal to submit your application. This step is relatively quick.

3. Application Submission:

   • Time Needed: 1 to 2 days.
   • After creating your account, you can submit the Medical Device License (MDL) application through the portal. Ensure that all necessary documents are uploaded (e.g., device description, labeling, IFU, etc.) and that the application is complete.

4. Health Canada Review:

   • Time Needed: Typically 1 to 2 weeks.
   • Health Canada will review your application for completeness, compliance with regulations, and adequacy of the documentation. This review generally takes 1 to 2 weeks for Class I devices because these are lower-risk products, and the process is less rigorous than for higher-risk devices.
   • If everything is in order, your device will be approved for sale in Canada, and Health Canada will issue your Medical Device License (MDL).

5. Issuance of MDL:

   • Time Needed: Immediately after the review is complete (if there are no issues).
   • Once the application is approved, Health Canada will issue the MDL, allowing the device to be marketed and sold in Canada.

Estimated Total Timeline:

For Class I IVD MDL registration, the entire process can typically take between 2 to 6 weeks, assuming all documentation is in order and there are no issues with the application.

Key Factors that May Impact Timeline:

• Completeness of the Application: If the application is incomplete or requires additional documentation, the timeline may be extended.
• Labeling and Documentation: Ensure that all labeling is bilingual (English and French), and that all necessary documentation is clear and comprehensive.
• Health Canada Requests: If Health Canada has questions or requests further clarification on any aspects of the application, this may extend the review timeline.

Renewal Process:

• The MDL for Class I devices is valid for one year, and you will need to submit an annual renewal application before the license expires.
• The renewal process usually takes a few weeks to complete, assuming there are no issues.

Summary Timeline:

• Preparation: 1 to 4 weeks
• Submission: 1 to 2 days
• Health Canada Review: 1 to 2 weeks
• Issuance of MDL: Upon approval, immediately
• Total: 2 to 6 weeks (average)

This timeline can vary slightly depending on the specifics of your application and the device.