The costs and time required to apply for the Class I in vitro diagnostic (IVD) medical device MDL registration in Canada can vary, but here’s a general overview of the process:

1. Cost to Apply for Class I IVD MDL Registration

The primary costs involved in registering a Class I IVD device in Canada are typically associated with the Medical Device Establishment License (MDEL) and the registration process. Here's an outline of potential costs:

• Medical Device Establishment License (MDEL) Application Fee:

  • Initial Application Fee: Health Canada charges a fee for processing an MDEL application. The cost depends on the type and size of the establishment, but as of 2024, the application fee for MDEL is typically in the range of CAD $5,000 to CAD $10,000.
  • Annual Maintenance Fee: Once the MDEL is granted, there is usually an annual maintenance fee to keep the license active. This fee generally ranges from CAD $2,000 to CAD $4,000 per year, depending on your company’s activities (e.g., manufacturing, importing, distributing).

• Additional Costs (Optional):

  • Canadian Authorized Representative: If you are a foreign manufacturer, you must designate a Canadian Authorized Representative. The fees for appointing a representative vary but typically range from CAD $1,000 to CAD $5,000 per year, depending on the services offered by the representative.
  • Quality Management System (QMS): If you decide to implement a Quality Management System (QMS) such as ISO 13485, there could be additional costs associated with training, auditing, and maintaining the system. These costs will vary depending on the scope of the QMS and whether you outsource any auditing or consulting services.

2. Time Required to Apply for Class I IVD MDL Registration

The time required to obtain an MDEL and register a Class I IVD device in Canada is generally faster than for higher-class devices (Class II, III, IV), but the process still depends on several factors. Here's an estimate of the timeline:

• MDEL Processing Time:
  • Initial Review: The review process for an MDEL application typically takes approximately 30 to 90 days after submission. However, this timeline can vary depending on the completeness of your application and Health Canada’s workload.
  • Approval Time: If your application is complete and meets all requirements, you can generally expect approval within 2 to 3 months. In some cases, if additional information is needed, it may take longer.
• Post-Approval:
  • Once your MDEL is granted, you can legally distribute your Class I IVD device in Canada, provided it meets the requirements for labeling, safety, and performance.
  • Device Registration and Importation: Since Class I devices do not require pre-market approval, there is no extended waiting period for device-specific approval. However, if you are importing the device, you must ensure that the device complies with the Medical Device Regulations (MDR) before distribution.

3. Total Time Estimate

• Overall Time: From the time of submission to the receipt of your MDEL and registration of the device, the total time required is typically between 3 to 6 months. This includes time for gathering required documentation, application submission, and review by Health Canada.
• If there are complications or additional requirements (e.g., issues with labeling, more documentation needed), the process could take longer.

Summary of Costs and Time:

• Costs:

  • MDEL Application Fee: CAD $5,000 to CAD $10,000 (initial) and CAD $2,000 to CAD $4,000 annually.
  • Canadian Authorized Representative: CAD $1,000 to CAD $5,000 annually (if applicable).
  • Optional QMS Implementation: Additional costs if you choose to implement ISO 13485 or other quality systems.

• Time:

  • MDEL Processing Time: Generally 30 to 90 days for approval.
  • Overall Time for Registration: Typically 3 to 6 months to complete the process, including all steps from application to approval.

These are rough estimates and may vary based on specific circumstances such as the complexity of the device, completeness of the application, and Health Canada’s current workload.

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