For Class II in vitro diagnostic (IVD) medical device Medical Device License (MDL) registration in Canada, several standards must be adhered to in order to demonstrate compliance with safety, effectiveness, and quality requirements. These standards provide a framework for the design, manufacture, and testing of medical devices. Here are the key standards relevant to Class II IVDs:

1. ISO 13485:2016

• Quality Management Systems for Medical Devices: 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. ISO 14971:2019

• Application of Risk Management to Medical Devices: This standard provides a systematic process for managing risks associated with medical devices. It covers risk analysis, evaluation, control, and monitoring, and is crucial for demonstrating the safety of the device.

3. ISO 15189:2012

• Medical Laboratories—Particular Requirements for Quality and Competence: If the device is intended for use in a laboratory setting, compliance with this standard can help ensure that laboratory processes meet international quality standards.

4. IEC 62366-1:2015

• Application of Usability Engineering to Medical Devices: This standard outlines the process of usability engineering to ensure that the device can be used safely and effectively by the intended users in the intended environment.

5. ISO 17511:2003

• In Vitro Diagnostic Medical Devices—Requirements for the Specification of Metrological Traceability of In Vitro Diagnostic Measurements: This standard provides guidance on ensuring the traceability of IVD test results to reference materials or methods, which is important for the reliability of diagnostic results.

6. ISO 18113-1:2011

• In Vitro Diagnostic Medical Devices—Information Supplied by the Manufacturer: This standard covers labeling and information requirements for IVD devices, ensuring that users receive adequate instructions and information to use the device safely and effectively.

7. Health Canada Guidance Documents

• Guidance on the Risk Classification of IVD Medical Devices: This document outlines the classification rules for IVD medical devices and provides guidance on how to assess the risk associated with the device.
• Medical Device Regulations: Compliance with the Canadian Medical Devices Regulations (SOR/98-282) is essential for all medical devices, including Class II IVDs.

8. Other Relevant Standards

• Depending on the specific type of IVD device, other standards may also apply, such as those related to microbiological testing, molecular diagnostics, or specific analytes.

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