To apply for the Class I in vitro diagnostic (IVD) medical device MDL (Medical Device License) registration in Canada, you must follow specific steps outlined by Health Canada. Here is a detailed guide on how to apply for registration:

Steps to Apply for Class I IVD MDL Registration in Canada:

1. Confirm Your Device's Classification

• Class I Classification: Before starting the registration process, ensure that your device is indeed classified as Class I under Canadian regulations.
  • Class I devices are considered low-risk devices and generally require fewer regulatory controls.
  • For in vitro diagnostic (IVD) devices, you need to confirm that the device is low-risk and qualifies as Class I. These include devices such as IVD reagents, general laboratory equipment, or simple diagnostic tests.

2. Appoint a Canadian Authorized Representative (CAR)

• If you are a manufacturer located outside of Canada, you are required to appoint a Canadian Authorized Representative (CAR) to facilitate communication between Health Canada and your company.
• The CAR will submit the MDL application on your behalf and manage any regulatory issues that arise in Canada.

Note: If you are based in Canada, this step is not necessary.

3. Prepare the Required Documentation

To apply for an MDL, the following documents are needed:

• Device Description: A clear description of the device, including its intended use and technical characteristics.
• Labeling:
  • All labeling must meet Health Canada’s language requirements, i.e., labels must be bilingual (English and French) and include proper usage instructions and safety warnings.
  • A sample of the device label and packaging must be included.
• Instructions for Use (IFU): Provide the IFU in both English and French, as per regulatory requirements.
• Quality Management System (QMS): Although ISO 13485 certification is not mandatory for Class I devices, it is highly recommended to ensure compliance with quality management requirements. A QMS will ensure the device is consistently produced to meet regulatory standards.
• Certificate of Free Sale (if applicable): If your device is marketed in other jurisdictions (such as the EU or US), include a Certificate of Free Sale, which verifies that the device is legally available in the country of origin.

4. Create an Account on Health Canada's Medical Device Establishment (MDE) Online Portal

• To submit your application, you need to access the Medical Device Establishment (MDE) Online portal:
  • MDE Portal: This is Health Canada's official platform for device submissions.
  • You need to register an account on the portal if you do not already have one.

5. Submit the MDL Application

• Complete the MDL application form available through the MDE portal.
• The application form will require information about the device, the manufacturer (or Canadian Authorized Representative), and the device classification.
• Upload all necessary documents (e.g., device description, labeling, quality management system, and IFU).

6. Pay the Application Fee

• Application Fee: There is a registration fee for Class I devices, which must be paid at the time of submission.
• You will need to pay this fee electronically through the MDE portal during the application submission process.
• The fee schedule is updated annually by Health Canada, and it can vary depending on the size and complexity of the application.

7. Health Canada Review

• Once the application and payment are submitted, Health Canada will review the MDL application. The review process typically takes 1-2 weeks for Class I devices since they are considered low-risk and do not require pre-market approval.
• Health Canada will check for:
  • Completeness of documentation (labeling, device description, etc.)
  • Proper classification of the device
  • Compliance with Canadian regulations
  • Proper bilingual labeling and instructions for use

8. MDL Issuance

• Approval: If everything is in order, Health Canada will issue the Medical Device License (MDL) for your Class I device.
• Once the MDL is granted, you are authorized to legally market and sell the device in Canada.

9. Post-Market Compliance and Ongoing Requirements

• Annual Renewal: The MDL is valid for one year. You will need to submit an annual renewal application and pay the renewal fee to keep the MDL active.
• Adverse Event Reporting: If any adverse events (e.g., safety concerns or device malfunction) occur after the device is on the market, you must report these events to Health Canada.

Summary of Steps:

1. Confirm Device Classification: Ensure the device qualifies as Class I.
2. Appoint a Canadian Authorized Representative (if applicable).
3. Prepare Required Documentation: Include the device description, labeling, instructions for use, and any other necessary documents.
4. Create an Account on the MDE Online Portal.
5. Submit MDL Application: Complete the application form and submit the required documents through the MDE portal.
6. Pay the Application Fee: Pay the applicable fee for MDL registration.
7. Health Canada Review: Health Canada reviews the application and documentation.
8. MDL Issuance: Receive the Medical Device License to market the device in Canada.
9. Post-Market Compliance: Comply with ongoing requirements, including annual renewal and adverse event reporting.

Conclusion:

By following these steps and submitting a complete application, you can successfully apply for Class I in vitro diagnostic (IVD) medical device MDL registration in Canada. Be sure to maintain accurate documentation and stay informed of any regulatory updates from Health Canada.

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