To register for a Class II in vitro diagnostic (IVD) medical device Medical Device License (MDL) in Canada, follow these detailed steps:

Step-by-Step Registration Process

1. Determine Device Classification

• Confirm that your device is classified as Class II IVD by reviewing the Medical Device Regulations and the Health Canada classification rules.

2. Prepare Technical Documentation

• Gather and prepare the necessary documents, including:
  • Device Description: A comprehensive overview of the device, its intended use, and how it works.
  • Performance Data: Results from analytical and clinical testing demonstrating the device's safety and effectiveness.
  • Risk Management File: Document risks associated with the device and mitigation strategies, in compliance with ISO 14971.
  • Labeling and Instructions for Use (IFU): Ensure compliance with bilingual labeling requirements and include clear instructions for safe use.

3. Establish a Quality Management System (QMS)

• Implement a QMS that complies with ISO 13485. This includes documenting processes for design, production, and post-market activities.

4. Conduct Performance Testing

• Perform necessary analytical and clinical tests. Document all findings thoroughly to support your application.

5. Complete Application Form

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

6. Compile the Application Package

• Assemble the application package, including:
  • Completed Form 3011
  • Technical documentation
  • Performance data
  • Risk management documentation
  • Quality management system documents
  • Labeling and IFU

7. Submit the Application

• Submit the complete application package through the Medical Device eSubmission System. Ensure you pay any applicable fees at the time of submission.

8. Health Canada Review Process

• Health Canada will review your application. This process includes:
  • Initial Screening: Checking for completeness.
  • Technical Review: Detailed evaluation of the submitted documentation.
  • Compliance Check: Ensuring compliance with regulations and standards.

9. Respond to Information Requests

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

10. Receive License Decision

• Health Canada will issue a decision on your 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

• After receiving the MDL, implement post-market surveillance to monitor device performance, report adverse events, and maintain compliance with ongoing regulatory requirements.

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