When applying for Class III in vitro diagnostic medical devices (IVDs) Medical Device License (MDL) registration in Canada, adherence to specific standards is crucial. These standards ensure the safety, effectiveness, and quality of the medical devices. Here are the key standards typically applicable:

1. Quality Management System (QMS) Standards

• ISO 13485: This standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and regulatory requirements.

2. Risk Management Standards

• ISO 14971: This standard outlines the process for risk management for medical devices. It includes identifying hazards, assessing risks, and implementing controls to mitigate risks throughout the lifecycle of the device.

3. Clinical Evaluation Standards

• ISO 14155: This standard provides guidelines for the design and conduct of clinical trials for medical devices, including the ethical considerations and data reporting.

4. Standards for In Vitro Diagnostic Devices

• ISO 17511: This standard addresses the requirements for the establishment of metrological traceability for in vitro diagnostic devices.
• ISO 15189: This standard specifies requirements for quality and competence in medical laboratories, which may be relevant if your device is used in a laboratory setting.
• ISO 22870: This standard covers the requirements for point-of-care testing.

5. Performance Evaluation Standards

• ISO 20916: This standard provides guidance on the performance evaluation of IVDs, including design verification and validation.
• IEC 62366: This standard outlines the process for the usability engineering of medical devices, focusing on the design and evaluation of user interfaces.

6. Product-Specific Standards

• Depending on the specific type of IVD, additional product-specific standards may apply. For example:
  • ASTM International Standards: Various ASTM standards may apply depending on the nature of the diagnostic device and its intended use.

7. Regulatory Compliance

• Ensure compliance with the Medical Devices Regulations (SOR/98-282) under the Food and Drugs Act in Canada, which govern the licensing, manufacturing, and distribution of medical devices.

Additional Considerations

• Consult Health Canada Guidance: Review Health Canada’s guidance documents for additional regulatory requirements and standards specific to your device type.
• Engage Regulatory Experts: Consider consulting with regulatory affairs professionals to ensure your device meets all relevant standards and requirements.

By adhering to these standards, you can enhance the quality of your application for Class III IVD MDL registration in Canada.

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