To register for the Class I in vitro diagnostic (IVD) medical device MDL (Medical Device License) in Canada, you need to follow a clear process set by Health Canada. Here’s a step-by-step guide on how to register your Class I IVD device:

Step-by-Step Process for Registering Class I IVD MDL in Canada

1. Verify Device Classification

• Class I Devices: Before applying, ensure that your IVD device is classified as Class I. Class I devices are low-risk and usually include basic diagnostic tools, reagents, or laboratory equipment.
• The classification must be in line with the Medical Device Regulations (SOR/98-282) under Canadian law.
• IVD Device: Your device must be intended for in vitro diagnostic use, such as diagnostic tests or reagents.

2. Appoint a Canadian Authorized Representative (CAR) (if applicable)

• If you are based outside of Canada: You must appoint a Canadian Authorized Representative (CAR) to facilitate communication between your company and Health Canada.
• The CAR will act on behalf of the manufacturer to submit the MDL application and manage ongoing regulatory matters in Canada.
• If you are based in Canada: You do not need a CAR and can apply directly.

3. Prepare Required Documentation

To submit a successful application, you will need the following documents:

• Device Description: A detailed description of the device, including its intended use, technological specifications, and how it works.
• Labeling:
  • All device labels must be bilingual (English and French).
  • Include sample labels for both the device itself and its packaging. Labels should provide instructions for use and any necessary warnings or contraindications.
• Instructions for Use (IFU): Provide a copy of the IFU, also in English and French.
• Quality Management System (QMS): Although ISO 13485 certification is not mandatory for Class I devices, it’s recommended to implement a quality management system to ensure product consistency and regulatory compliance.
• Certificate of Free Sale (optional): If your device is already marketed in other jurisdictions (such as the EU or the US), you may need to provide a Certificate of Free Sale.

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

• You need to create an account on Health Canada’s MDE Online Portal to submit the application.
  • Link to the MDE portal: MDE Online Portal
• After creating an account, you can log in to complete the application and upload your documents.

5. Complete the MDL Application

• Fill out the MDL Application Form on the MDE portal. The application form will require the following:
  • Manufacturer details (or CAR, if applicable).
  • Device classification information.
  • Intended use of the device.
  • Document uploads (e.g., device description, labeling, IFU).
• Submit the form and ensure that all necessary information is provided.

6. Pay the Application Fee

• Application Fee: There is a non-refundable application fee for submitting the MDL.
• You can make the payment through the MDE portal at the time of submission.
• The fee amount may vary annually, so check the Health Canada website for the current fee schedule.

7. Health Canada Review

• After submission, Health Canada will review the application to ensure that the device complies with Canadian medical device regulations.
• The review process for Class I devices is typically faster, and it can take 1-2 weeks for approval, provided the application is complete and there are no issues.
• Health Canada will check for:
  • Accuracy and completeness of the documents.
  • Correct classification of the device.
  • Compliance with labeling and bilingual requirements.
  • Adequate safety and usage information.

8. MDL Issuance

• If Health Canada finds the application in order, they will issue the Medical Device License (MDL) for your device.
• The MDL allows you to legally market and distribute the device in Canada.
• The MDL is valid for one year from the date of issuance. You will need to renew it annually.

9. Post-Market Compliance

• Renewal: You must submit an annual renewal application for the MDL, along with the renewal fee.
• Adverse Event Reporting: You are required to report any adverse events or safety concerns related to your device to Health Canada.
• Maintain Compliance: Ensure that your device continues to meet Health Canada’s standards throughout its market lifecycle.

Summary of Steps:

1. Verify device classification: Ensure the device is Class I.
2. Appoint a Canadian Authorized Representative (if applicable).
3. Prepare the required documents: Device description, labeling, IFU, quality management information.
4. Create an account on the MDE portal.
5. Complete the MDL application and submit the required documents.
6. Pay the application fee.
7. Health Canada review: Health Canada reviews the submission and documentation.
8. MDL Issuance: Receive the Medical Device License.
9. Post-market compliance: Annual renewal, adverse event reporting, and ongoing compliance.

By following these steps, you can successfully register your Class I in vitro diagnostic medical device with Health Canada and legally sell and distribute the device in the Canadian market.

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