The timeline for applying for a Class II in vitro diagnostic (IVD) medical device Medical Device License (MDL) registration in Canada can vary based on several factors, including the completeness of the application, the complexity of the device, and the current workload of Health Canada. Here’s an overview of the expected timeline and the review process:

Timeline for MDL Registration

1. Preparation Phase:

   • The time required to prepare the application can vary widely depending on the complexity of the device and the availability of data. This phase may take several weeks to months, especially if extensive testing or documentation is needed.

2. Submission Phase:

   • Once the application is submitted, Health Canada aims to complete the initial review within 30 days. However, this period can be longer if additional information is required.

3. Review Phase:

   • The overall review process typically takes 60 to 120 days, but it can take longer if:
     • The application is complex.
     • Additional information or clarification is needed.
     • Health Canada has a high volume of submissions at the time.

4. Total Timeframe:

   • In total, the entire process from preparation to receiving a decision can range from a few months to over a year, depending on the specifics of the application and the device.

Review Process

The review process by Health Canada includes several key steps:

1. Initial Screening:

   • Health Canada conducts an initial screening of the submitted application to ensure that it is complete and that all required documents and information are included.

2. Technical Review:

   • A detailed assessment of the technical documentation is performed, which includes:
     • Evaluation of the device description, specifications, and intended use.
     • Review of performance testing data (both analytical and clinical).
     • Assessment of risk management documentation (compliance with ISO 14971).
     • Verification of labeling and Instructions for Use (IFU).

3. Safety and Effectiveness Evaluation:

   • Health Canada evaluates the safety and effectiveness of the device based on the submitted data. This includes assessing whether the performance claims are supported by the evidence provided.

4. Compliance Check:

   • The application is checked for compliance with applicable regulations, standards, and guidelines, including ISO 13485 for quality management systems.

5. Request for Additional Information:

   • If Health Canada identifies any gaps or requires further clarification, they will issue a request for additional information. The applicant must respond to these requests within a specified timeframe.

6. Final Decision:

   • After completing the review, Health Canada will issue a decision. If approved, the applicant will receive the Medical Device License (MDL). If not approved, the applicant will be provided with reasons for the decision, and they may need to address these issues before reapplying.

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