Applying for a Class II in vitro diagnostic (IVD) medical device Medical Device License (MDL) registration in Canada involves a series of detailed processes. Here’s a breakdown of the key processes involved:

1. Device Classification Confirmation

• Identify Classification: Confirm that your device qualifies as a Class II IVD by reviewing the classification criteria set by Health Canada.

2. Prepare Technical Documentation

• Device Description: Create a comprehensive description of the device, including its intended use, design, and function.
• Performance Data: Gather and document results from analytical and clinical performance testing, demonstrating the device's safety and effectiveness.
• Risk Management: Develop a risk management file in compliance with ISO 14971, detailing identified risks and mitigation strategies.
• Labeling and Instructions for Use (IFU): Prepare labeling materials, ensuring they meet bilingual requirements and include all necessary information for safe and effective use.

3. Quality Management System (QMS) Implementation

• ISO 13485 Compliance: Establish a QMS that complies with ISO 13485 standards, including processes for design control, manufacturing, and post-market surveillance.

4. Conduct Performance Testing

• Analytical Testing: Perform laboratory tests to assess the device’s performance characteristics (e.g., sensitivity, specificity).
• Clinical Testing: If applicable, conduct clinical studies to validate the device’s effectiveness in a real-world setting.

5. Complete the Application Form

• Form 3011: Fill out the Application for a Medical Device License (Form 3011), ensuring all required fields are completed accurately.

6. Compile Application Package

• Supporting Documents: Assemble all necessary documents, including:
  • Technical documentation
  • Performance data
  • Risk management files
  • Quality management system documentation
  • Completed Form 3011

7. Submit the Application

• Medical Device eSubmission System: Submit the application package through Health Canada’s Medical Device eSubmission System and pay any applicable fees.

8. Health Canada Review Process

• Initial Screening: Health Canada will perform a preliminary review to ensure completeness of the application.
• Technical Review: A detailed evaluation of the submitted documents, performance data, and risk management files will be conducted.
• Compliance Check: Health Canada will assess compliance with applicable regulations and standards.

9. Respond to Information Requests

• Additional Information: Be prepared to provide additional information or clarification if Health Canada requests it during their review process.

10. Receive License Decision

• Approval or Denial: Health Canada will issue a decision on the MDL application. If approved, you will receive the Medical Device License; if denied, you will receive feedback on the reasons for denial.

11. Post-Market Obligations

• Implement Post-Market Surveillance: After receiving the MDL, monitor device performance and safety, report adverse events, and ensure ongoing compliance with regulatory requirements.

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