The costs and timeframes for applying for Class III in vitro diagnostic medical devices (IVDs) Medical Device License (MDL) registration in Canada can vary based on several factors. Here’s a general overview:

Costs

1. Application Fees:

   • The fee for a Class III MDL application is typically in the range of CAD 12,000 to CAD 20,000, depending on the specifics of the application and any additional services required.

2. Additional Costs:

   • There may be additional costs for clinical studies, documentation preparation, and quality management system implementation or audits. Engaging consultants for regulatory affairs can also add to the total cost.

Timeframes

1. Preparation Time:

   • Preparing the application can take several months, depending on the complexity of the device and the availability of data.

2. Review Time:

   • Health Canada’s review process for Class III applications typically takes about 90 to 180 days from the date of submission, but this can vary based on the completeness of the application and whether Health Canada requests additional information.

3. Overall Timeline:

   • The total timeframe from initial preparation to receiving the MDL can range from six months to over a year, considering preparation, submission, and review times.

Additional Considerations

• Consulting Experts: Engaging regulatory consultants can help streamline the process but will add to the costs.
• Plan for Delays: Be prepared for potential delays, especially if additional information is requested by Health Canada.

For the most accurate and up-to-date information, it’s advisable to consult the Health Canada website or reach out to regulatory affairs professionals.

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn