When applying for Class III in vitro diagnostic medical devices (IVDs) Medical Device License (MDL) registration in Canada, you must meet specific requirements set by Health Canada. Here’s an overview of the key requirements:

1. Device Classification

• Ensure your device is correctly classified as Class III based on Health Canada’s classification rules.

2. Device License Application (MDL)

• Application Form: Complete the Medical Device License Application form.
• Device Description: Provide detailed specifications, including materials, design, and intended use.
• Indications for Use: Clearly outline what conditions the device is intended to diagnose or detect.

3. Clinical Evidence

• Safety and Effectiveness Data: Provide clinical data supporting the safety and performance of the device. This may include:
  • Results from clinical trials or studies.
  • Bench testing data.
  • Historical data from similar devices.

4. Labeling Information

• Include proposed labels, packaging, and instructions for use that comply with regulatory requirements.

5. Risk Management

• Provide a risk management plan demonstrating how risks associated with the device are identified, assessed, and mitigated (typically following ISO 14971).

6. Quality Management System (QMS)

• Demonstrate compliance with a recognized QMS standard (e.g., ISO 13485). This may require:
  • Quality system documentation.
  • Evidence of effective implementation and maintenance.

7. Manufacturing Information

• Include details about the manufacturing process and controls to ensure product quality and consistency.

8. Financial Disclosure

• If applicable, provide information about any financial interests or relationships that could affect the device’s development or marketing.

9. Submission Fees

• Pay the applicable fees for processing the MDL application.

10. Post-Market Requirements

• Prepare to comply with post-market surveillance and reporting obligations after receiving the MDL, including:
  • Adverse event reporting.
  • Ongoing quality management compliance.

Additional Considerations

• Consult Regulatory Guidance: Review Health Canada’s guidance documents for specific regulatory requirements and detailed information.
• Engage Experts: Consider consulting with regulatory affairs professionals to ensure that your application meets all necessary requirements.

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