The timeline for applying for the Class I in vitro diagnostic (IVD) medical device MDL registration in Canada is typically faster compared to higher-class devices, given that Class I devices are considered lower risk. However, the process still involves several steps and can vary depending on the completeness of your application and the responsiveness of Health Canada. Here's an outline of the typical timeline and review process:

Timeline for Class I IVD MDL Registration in Canada

1. Preparation of Documentation (1-3 weeks)

   • Before submission, you will need time to prepare all the required documentation for the MDL application. This includes device labeling, a device description, and other supporting documents (such as the Certificate of Free Sale, if applicable).
   • If the device is already marketed in another jurisdiction (such as the EU or US), you may already have some of the required documentation, which can speed up this phase.

2. Submission of MDL Application (1 day)

   • Once all the documentation is gathered, you can submit your MDL application through Health Canada's MDE Online Portal.
   • This step typically takes 1 day for submission, though it may take a bit longer if the form is complex or requires clarification.

3. Health Canada Review (1-2 weeks)

   • Health Canada's Review: Health Canada will review the submission to ensure that it meets all necessary regulatory requirements. Since Class I devices are low-risk, the review is usually quick, generally taking around 1-2 weeks.
     • Health Canada will check the completeness of your application, ensuring that the device is properly classified, the labeling meets regulatory standards, and the quality management system (if applicable) aligns with the requirements.

4. Issuance of MDL (1-2 weeks)

   • Approval and MDL Issuance: After reviewing the application and confirming that everything is in order, Health Canada will issue the Medical Device License (MDL).
   • The MDL issuance process typically takes 1-2 weeks after the review phase, as long as there are no issues with the application.

5. Total Time (3-6 weeks)

   • Overall Timeline: From the moment you begin gathering documents to the moment you receive your MDL, the process can take approximately 3-6 weeks, assuming there are no significant issues or requests for additional information from Health Canada.

Steps Involved in the Review Process

1. Initial Application Review

   • Completeness Check: Health Canada will first ensure that the MDL application form has been completed correctly and all required documentation has been submitted. This includes checking the device description, labeling, and manufacturer details.
     • Missing Information: If any information is missing or unclear, Health Canada will notify you and request the missing data, which could cause delays.

2. Evaluation of Device Classification

   • Risk Classification: Health Canada will verify that the device is correctly classified as Class I. This is important because Class I devices are subject to fewer regulatory requirements than higher-risk devices, but must still comply with all applicable regulations, including labeling and safety standards.

3. Review of Device Documentation

   • Device Description: Health Canada will review the detailed device description to confirm that the device falls under the correct classification and that it complies with Canadian requirements.
   • Labeling Review: The labeling will be checked to ensure it meets Health Canada's language requirements (bilingual English and French), contains proper usage instructions, and includes required safety information.
   • Quality Management System (if applicable): Although not required for Class I devices, manufacturers may be asked to show that they have a Quality Management System (QMS) in place to ensure that devices meet the required standards. Health Canada will ensure that the device conforms to any necessary quality standards.

4. Post-Submission Clarifications

   • If Health Canada has questions or needs clarification regarding any part of the application, they will contact you for additional information.
   • These requests can add time to the overall process, depending on how quickly you can provide the requested details.

5. Final Decision and MDL Issuance

   • If everything is in order, Health Canada will issue the Medical Device License (MDL), authorizing the device to be marketed and sold in Canada.
   • If any major issues are identified, Health Canada may refuse the MDL application and provide feedback on what needs to be addressed before resubmission.

Important Notes:

• Class I Devices Are Low-Risk: The process for Class I IVD devices is typically faster because these are lower-risk devices, and Health Canada does not require pre-market approval for them. However, you must still ensure that all documentation and labeling meet the necessary regulatory standards.
• Annual MDL Renewal: The MDL is valid for one year. You will need to submit an annual renewal application to keep the license active and continue selling the device in Canada.

Summary Timeline for Class I IVD MDL Registration:

1. Preparation of Documents: 1-3 weeks
2. Submission of MDL Application: 1 day
3. Health Canada Review: 1-2 weeks
4. MDL Issuance: 1-2 weeks
5. Total Time: 3-6 weeks

This timeline assumes no major issues arise during the process. The overall timeline can be shorter if the application is complete and Health Canada does not need to request additional information.

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