The process to obtain the Class I in vitro diagnostic (IVD) medical device MDL (Medical Device License) registration in Canada is generally quick compared to higher-risk devices, as the process for Class I devices is more streamlined. On average, it typically takes about 2 to 6 weeks to complete the entire process.

Breakdown of the Timeline:

1. Preparation of Documentation:

   • Time Needed: 1 to 4 weeks (depending on how quickly you can gather and prepare the necessary materials).
   • Before submitting your application, you need to prepare documentation such as:
     • Device description
     • Bilingual labeling (English and French)
     • Instructions for use (IFU)
     • Any quality management system documentation (if applicable).
   • The time required will depend on how readily available and complete this information is.

2. Account Creation and Application Submission:

   • Time Needed: 1 to 2 days.
   • You will need to create an account on the MDE (Medical Device Establishment) Online Portal if you haven't already.
   • Once your account is set up, submitting the actual application is quick and can be completed within 1 to 2 days.

3. Health Canada Review:

   • Time Needed: 1 to 2 weeks.
   • Health Canada typically reviews the application within 1 to 2 weeks for Class I devices. The review will focus on confirming that the application is complete and that the device complies with regulatory requirements.
   • As Class I devices are low-risk, the review process is generally less rigorous and quicker than for higher-risk devices.

4. Issuance of MDL:

   • Time Needed: Immediately after the review (if approved).
   • Once the review is complete and the application is approved, the Medical Device License (MDL) is issued, and the device can be legally marketed and sold in Canada.
   • This typically happens quickly, often within a few days after the review.

Estimated Total Time:

• 2 to 6 weeks for obtaining the Class I MDL, assuming no issues with the application.

Factors that Could Affect the Timeline:

• Completeness of the Application: If any documentation is missing or if Health Canada requests further information, the timeline could be extended.
• Labeling Compliance: Make sure that all labeling is bilingual (in English and French) to avoid delays.
• Quality Management System: If you are implementing a quality system like ISO 13485, ensure that all related documentation is up to date.

In summary, you can typically expect to receive the Class I MDL within 2 to 6 weeks from submission, assuming your application is complete and meets the necessary requirements.