The process for Class I in vitro diagnostic (IVD) medical device MDL (Medical Device License) registration in Canada involves several key steps that ensure compliance with Health Canada's Medical Device Regulations (MDR). Below is a detailed outline of the process and steps to follow:

1. Determine the Device Classification

• Class I Devices: First, confirm that your device is classified as Class I. In Canada, IVD medical devices are classified into four classes (Class I to IV) based on the risk they pose to patients and users.
  • Class I devices are considered low-risk devices and do not require pre-market approval from Health Canada. However, they must still be registered with the Medical Device Licensing (MDL) system.

2. Establish a Canadian Authorized Representative (CAR)

• Authorized Representative: If the manufacturer of the Class I IVD device is located outside of Canada, they must appoint a Canadian Authorized Representative (CAR). The CAR is responsible for communication with Health Canada regarding regulatory matters, including device registration.
  • Note: The CAR must be located in Canada and be responsible for the device's compliance with Health Canada's requirements.

3. Prepare Required Documentation

• Device Licensing: Gather the necessary documentation to submit the device for registration. This includes:
  • Device description: Detailed information about the device, including its intended use, design, and technology.
  • Labeling information: The labeling must include bilingual (English and French) labeling and detailed instructions for use (IFU).
  • Certificate of Free Sale (if applicable): This is a document that verifies the device is legally sold in the country of origin.
  • Quality Management System (QMS): While ISO 13485 certification is not required for Class I devices, manufacturers should have a QMS to ensure that their devices are consistently produced and controlled.

4. Submit MDL Application

• Online Submission: Class I IVD medical device registration is done through Health Canada's Medical Device Establishment (MDE) Online portal. The device registration form should be filled out and submitted electronically.
  • Ensure that all required fields are completed and that the device documentation is included with the submission.
  • The Canadian Medical Device License Application form must be completed with detailed information about the device, including the manufacturer’s details, device classification, and labeling.

5. Pay the Application Fee

• MDL Registration Fee: There is an associated fee for registering a Class I IVD device with Health Canada. The fee must be paid when submitting the MDL application. The fee schedule is outlined by Health Canada and can vary depending on the type and complexity of the device.
  • Fees must be paid electronically through the Health Canada portal at the time of submission.

6. Health Canada Review

• Review Process: Health Canada will review the submitted application and documentation. Since Class I devices are considered low risk, the review process is generally faster compared to higher-class devices. Health Canada will verify the completeness of your submission, ensuring that all required information is provided.
  • No Pre-Market Approval: Class I devices do not require pre-market approval, but the registration must be completed before the device can be legally marketed or sold in Canada.

7. MDL Issuance

• License Issuance: Once Health Canada reviews the application and confirms that it meets the regulatory requirements, the Medical Device License (MDL) for the device will be issued.
  • The MDL allows the device to be sold and distributed in Canada.

8. Ongoing Compliance and Post-Market Requirements

• Monitoring: After the device is registered, you must maintain compliance with ongoing regulatory requirements, including:
  • Adverse Event Reporting: Report any adverse events or safety issues associated with the device to Health Canada.
  • Annual Renewal: The MDL is valid for one year. You must renew it annually by submitting a renewal application and paying the renewal fee.
  • Device Modifications: If the device undergoes any significant changes, you must update Health Canada, including modifications to design, intended use, or labeling.

Summary of Steps for Class I IVD MDL Registration:

1. Determine Device Classification: Confirm that the device is classified as Class I.
2. Appoint a Canadian Authorized Representative (if applicable): If the manufacturer is outside Canada.
3. Prepare Required Documentation: Gather device description, labeling, quality management, and other relevant documents.
4. Submit the MDL Application: Complete and submit the application via the MDE Online portal.
5. Pay the Application Fee: Pay the applicable registration fee when submitting the application.
6. Health Canada Review: Health Canada reviews the application and documentation for completeness.
7. Receive MDL: Once approved, receive the Medical Device License to market and distribute the device in Canada.
8. Ongoing Compliance: Ensure compliance with post-market regulations, including adverse event reporting, device renewals, and modifications.

Additional Considerations:

• Ensure Proper Labeling: Ensure that the device labels are compliant with Health Canada's requirements, including bilingual (English and French) labeling and safety information.
• Post-Market Obligations: Even after registration, you must continue to monitor the device's performance and safety in the market, report adverse events, and renew the MDL annually.

By following these steps and maintaining proper documentation, you can successfully complete the registration process for a Class I in vitro diagnostic medical device MDL in Canada.