In Canada, Class II in vitro diagnostic (IVD) medical device registration refers to obtaining a Medical Device License (MDL) for Class II diagnostic devices, regulated by Health Canada under the Medical Devices Regulations (SOR/98-282). This license is required for devices intended to diagnose, treat, or monitor health conditions through analysis of samples from the human body, such as blood or tissue.

Overview of Class II IVD Medical Device Classification

Health Canada classifies medical devices into four risk-based classes, from Class I (lowest risk) to Class IV (highest risk). Class II IVDs fall into a moderate-risk category. They include devices like basic diagnostic assays or reagents that do not involve a high degree of complexity in testing or risk for users.

Applying for a Class II IVD Medical Device License (MDL)

To apply for a Class II IVD MDL in Canada, here are the required steps:

1. Confirm Device Classification
   Verify that your device is Class II under the Canadian Medical Device Regulations. You can check Health Canada’s classification rules for IVDs or consult the “Guidance Document: Classification of In Vitro Diagnostic Devices.”

2. Prepare a Quality Management System (QMS) Certification
   Class II devices must comply with the ISO 13485 standard, which is a globally accepted QMS standard for medical device manufacturers. Health Canada requires manufacturers to hold a Medical Device Single Audit Program (MDSAP) certification that includes Canadian regulatory requirements.

3. Gather Submission Documentation
   Prepare the following documents for submission:

   • Device Description: Include a detailed description of the device, its intended use, and operating principles.
   • Safety and Effectiveness Data: Provide evidence of the device’s safety and effectiveness, including performance testing results.
   • Labeling Information: Submit proposed labels, instructions for use, and any promotional materials.
   • Quality Management System (QMS) Documentation: Demonstrate your organization’s compliance with ISO 13485.

4. Complete the Medical Device License Application (Form 3011)
   Fill out Form 3011 from Health Canada’s website, providing details of the manufacturer, device specifications, and evidence of compliance with relevant standards.

5. Pay the Application Fee
   Health Canada charges a fee for medical device license applications. Ensure to review the fee schedule, as fees vary depending on the device classification and submission type.

6. Submit the Application
   Submit the completed application form and required documents electronically via the Medical Device eSubmission system (MDEL) portal, or submit them by mail.

7. Review and Approval by Health Canada
   Health Canada will review your application, assessing its compliance with the Medical Devices Regulations. The review may include requests for further information or clarification. If the submission meets the regulatory requirements, Health Canada will issue the Medical Device License (MDL) for your Class II IVD device.

8. Post-Market Obligations
   After approval, maintain compliance with Health Canada’s post-market monitoring, which includes reporting adverse events, complaints, or any changes to the device.

Resources for Further Guidance

• Health Canada’s Guidance Documents: Consult resources like the Guidance Document: Medical Device Licensing and Guidance for the Risk-based Classification System of In Vitro Diagnostic Devices for specific regulatory information.
• Medical Devices Regulations: Review the Canadian Medical Devices Regulations (SOR/98-282) for detailed legal requirements.
• Fees and Timeline: Check Health Canada’s website for the latest fee schedules and estimated review times for Class II applications.

Following these steps should guide you through the Class II MDL application for IVDs in Canada, ensuring regulatory compliance and market readiness.

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