To process Class II in vitro diagnostic (IVD) medical device Medical Device License (MDL) registration in Canada, manufacturers must meet Health Canada's requirements to ensure the device’s safety, quality, and effectiveness. Here’s a summary of key requirements:

1. Device Classification and Verification

• Classification as Class II: Confirm that the device meets the criteria for Class II, which generally applies to moderate-risk IVDs. Reference Health Canada’s Guidance Document: Classification of In Vitro Diagnostic Devices to verify classification.

2. Quality Management System (QMS) Certification

• ISO 13485 Certification: Your manufacturing facility must comply with ISO 13485, a standard for QMS specific to medical devices, ensuring consistency in manufacturing and quality control.
• MDSAP Certification: Health Canada mandates participation in the Medical Device Single Audit Program (MDSAP), which certifies that the QMS meets Canadian regulatory requirements under ISO 13485. MDSAP certification is essential for obtaining a Class II MDL.

3. Evidence of Device Safety and Effectiveness

• Device Description and Intended Use: Provide a detailed description of the device, including its intended use, design specifications, and key operating principles.
• Performance Testing and Validation Data: Submit data to demonstrate the device’s safety and effectiveness for its intended purpose. This can include analytical performance data, clinical validation (if required), and bench testing results.
• Risk Assessment: Provide a risk assessment or analysis consistent with ISO 14971 (Risk Management for Medical Devices), addressing any potential risks to the user.

4. Labeling and Instructions for Use

• Labeling Compliance: Include clear labeling that meets Health Canada’s regulatory requirements, ensuring labels provide sufficient information on intended use, directions, warnings, and limitations.
• Instructions for Use: The instructions should be detailed and easy to understand, guiding end-users through proper handling and use of the device.
• Language Requirements: All labels and instructions should be available in both English and French, Canada’s official languages.

5. Regulatory Submission Documentation (Form 3011)

• Medical Device License Application (Form 3011): Complete and submit Form 3011, detailing information about the device, manufacturer, and regulatory compliance.
• Supporting Documentation: In addition to Form 3011, the submission package should include:
  • Device specifications and design details
  • Safety and effectiveness evidence (e.g., testing results, validations)
  • Labeling information
  • QMS certification (MDSAP)
• Fees Payment: Pay the application fee, which varies based on device classification. Refer to the most recent fee schedule on Health Canada’s website.

6. Electronic Submission through Health Canada’s eSubmission Platform

• Use Health Canada’s Medical Device eSubmission System (MDEL Portal) for submitting the application electronically. Electronic submissions are faster and more efficient, providing real-time status updates and enabling tracking.

7. Post-Market Compliance and Reporting

• Adverse Event Reporting: Manufacturers are required to have a system in place for post-market monitoring and must report any adverse events or incidents involving the device to Health Canada.
• License Amendments for Device Changes: If there are significant changes to the device’s design, manufacturing, or intended use after licensing, notify Health Canada and potentially submit an amendment to the license.
• Annual Renewal and Quality System Audits: Maintain an updated MDSAP certification, as Health Canada may request evidence of ongoing compliance with the quality system requirements.

Key Documents and Resources

• Health Canada Guidance Documents: Guidance Document: Medical Device Licensing and Guidance on In Vitro Diagnostic Device Classification for regulatory requirements.
• Medical Devices Regulations (SOR/98-282): Familiarize yourself with regulatory obligations under the Canadian Medical Devices Regulations.
• Health Canada’s Website: Forms, guidance documents, submission portals, and fee schedules can be accessed through Health Canada’s website for up-to-date regulatory information.

Meeting these requirements and ensuring complete documentation and adherence to Health Canada’s guidelines will facilitate the processing of a Class II MDL for your IVD device in Canada.

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