The process for applying for the Class I in vitro diagnostic (IVD) medical device MDL registration in Canada involves several key steps. Below is an overview of the process, the required materials, and the key points to keep in mind when applying for the Medical Device Establishment License (MDEL) for a Class I IVD device.

1. Verify Device Classification

• Ensure that your device is classified as Class I under the Medical Device Regulations (MDR). Class I devices are generally low-risk, including IVD devices such as diagnostic test kits or laboratory devices.
• Class I devices do not require pre-market approval from Health Canada, but they still must comply with regulatory requirements.

2. Designate a Canadian Authorized Representative (if applicable)

• If the manufacturer is located outside Canada, you must designate a Canadian Authorized Representative to act as the liaison between your company and Health Canada.
• This representative must be authorized to receive regulatory communications on your behalf and assist with any necessary regulatory processes.

3. Prepare Required Documentation

The following documents and information are typically required when applying for an MDEL and registering a Class I IVD device with Health Canada:

• Device Labeling:

  • Labeling must comply with Health Canada’s requirements. This includes:
    • The name of the device and intended use (e.g., diagnostic or monitoring).
    • Instructions for use, including handling, storage, and safety precautions.
    • Manufacturer information, or the details of the Canadian Authorized Representative if applicable.
    • Risk information, including any potential hazards or contraindications.

• Device Description:

  • A detailed description of the device, including its components, materials, and intended use.
  • Functionality of the device, such as how it is used and what it is designed to detect or monitor.

• Self-Declaration of Conformity:

  • A declaration that your device meets the Medical Device Regulations (MDR) set out by Health Canada.
  • This includes confirming that the device complies with safety, effectiveness, and labeling requirements.

• Quality Management System (QMS) (optional but recommended):

  • Although ISO 13485 (or equivalent QMS) is not mandatory for Class I devices, having a QMS in place can help ensure ongoing compliance with regulations. It is especially useful if you plan to move to higher-class devices in the future.
  • Risk management practices should also be outlined to ensure device safety.

4. Submit the Medical Device Establishment License (MDEL) Application

• Online Submission: You must submit your MDEL application through Health Canada’s Medical Device Licensing System (MDLS).
  • Create an account on the Health Canada’s Electronic Submission System (ESS).
  • Use the MDLS to submit the application and the required documents, including device labeling, self-declaration of conformity, and manufacturer details.
• Application Fee: There is an application fee for the MDEL, typically ranging from CAD $5,000 to CAD $10,000 for Class I devices.
  • Additionally, there is an annual maintenance fee for the MDEL, usually ranging from CAD $2,000 to CAD $4,000.

5. MDEL Application Review

• Health Canada will review your application for the MDEL, including the device labeling, self-declaration of conformity, and any other documentation provided.
• The review process for the MDEL application typically takes 30 to 90 days.
• If the application is complete and meets all requirements, Health Canada will issue the MDEL. In some cases, Health Canada may request additional information or clarification before issuing the license.

6. Post-Market Surveillance

• After your Class I IVD device is on the market, you must adhere to post-market surveillance requirements, including:
  • Reporting Adverse Events: If there are any adverse events or issues with the device after it is on the market, these must be reported to Health Canada.
  • Recall Procedures: You must have processes in place to recall the device if any defects or safety concerns arise.

7. Maintain Compliance

• Once the MDEL is issued, you must maintain compliance with Health Canada’s Medical Device Regulations (MDR) throughout the lifecycle of the device.
• This includes keeping documentation updated and addressing any regulatory requirements related to device modifications or post-market surveillance.

Key Points to Remember When Applying for Class I IVD MDL Registration:

1. Device Classification: Verify that your device qualifies as Class I based on intended use and risk profile.
2. Canadian Authorized Representative: If the manufacturer is located outside Canada, designate an authorized representative.
3. Prepare Thorough Documentation:
   • Device labeling and instructions for use must be compliant.
   • Submit a self-declaration of conformity confirming that the device meets regulatory standards.
4. Submit Application via MDLS: Complete the application online through Health Canada's Medical Device Licensing System.
5. Costs: Be prepared for the application fees (approximately CAD $5,000 to CAD $10,000) and annual maintenance fees (CAD $2,000 to CAD $4,000).
6. Timeline: The review process typically takes 30 to 90 days, with an overall application time of 3 to 6 months.
7. Post-Market Surveillance: Once the device is on the market, you must comply with adverse event reporting and recall procedures.

By following these steps and ensuring that all required materials are in place, you can successfully apply for the MDEL and register your Class I IVD medical device in Canada.

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