The application timeline for the Class I in vitro diagnostic (IVD) medical device MDL registration in Canada can vary depending on several factors, including the completeness of the application and Health Canada’s processing times. However, the general timeline is as follows:

1. Application Preparation:

• Time Required: This step involves gathering all the necessary documentation, including the self-declaration of conformity, device labeling, and device description. It also includes ensuring that the device complies with the Medical Device Regulations (MDR).
• Estimated Time: This process can take several weeks to a few months, depending on the complexity of the device and the availability of information.

2. Submitting the Application:

• Once you have all the necessary documents, you will submit the MDEL application through the Health Canada Medical Device Licensing System (MDLS).
• This is an online process, and you will need to create an account on the Electronic Submission System (ESS) to submit the application.
• Time to Submit: The submission itself can be completed in a few hours to a day, depending on the ease of uploading the required documents.

3. Health Canada Review Process:

• Review Timeline: Once submitted, Health Canada typically processes Class I IVD medical device MDL applications within 30 to 90 days.
  • For Class I devices, the review process is generally quicker compared to higher-risk classes (e.g., Class II, III, or IV). The application is primarily checked for completeness and compliance with regulatory requirements.
  • Health Canada may request additional information or clarification during this period, which can extend the review timeline.

4. Issuance of MDEL (Medical Device Establishment License):

• If the application is complete and meets all regulatory requirements, Health Canada will issue the MDEL for the Class I IVD medical device.
• Time to Receive MDEL: Once the application is approved, it typically takes about 1-2 weeks to receive the official MDEL.

5. Post-Approval (if applicable):

• After receiving the MDEL, you will need to comply with ongoing post-market surveillance and annual maintenance fees to keep your registration active.
• Annual Maintenance: Health Canada requires payment of an annual maintenance fee, which can range from CAD $2,000 to CAD $4,000 per year.

Overall Estimated Timeline:

1. Preparation: 2 weeks to 2 months (depending on documentation complexity).
2. Submission: A few hours to 1 day.
3. Health Canada Review: 30 to 90 days.
4. Issuance of MDEL: 1 to 2 weeks after approval.

Thus, the total timeline for obtaining an MDEL for a Class I in vitro diagnostic device in Canada is generally around 3 to 6 months from the start of the application process to the issuance of the license, assuming there are no significant delays or requests for additional information.