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Health Canada Issues Final Guidance on Clinical Evidence Requirements for Medical Devices

Health Canada finalized guidance on clinical evidence requirements for medical devices.

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December 5, 2022

Health Canada has finalized the Guidance on Clinical Evidence Requirements for Medical Devices. This guidance outlines the general principles and criteria for clinical evidence that may be required for Class III and IV license applications or requested for certain Class II license applications and other obligations throughout a medical device's life cycle.

In addition, the guidance provides discussions on when clinical data/evidence is required, what common methods to use in generating clinical data, and how to compare devices appropriately. A companion document that provides specific examples of clinical evidence requirements to help manufacturers determine if clinical evidence will be required or requested is also included in the guidance.

Specifics of the clinical evidence requirement guidance

The guidance document outlines a number of specific points about clinical evidence requirements.

The document outlines:

  • When clinical data/evidence may be required as part of a pre-market license application.
  • The types and quality of clinical evidence that may be required to support the safety and effectiveness of a medical device.
  • The use of clinical evidence from comparator devices for the purpose of a pre-market application.
  • The various ways that clinical data may be generated.
  • The various ways that identity factors such as sex, gender, race and ethnicity may be integrated.
  • When clinical data/evidence may be required as part of a post-market obligation.

The evidence required to support a medical device license application is proportional to the risk of the device. Class I devices represent the lowest possible risk (for example, a tongue depressor) and Class IV devices represent the highest potential risk (for example, a pacemaker).

The clinical evidence described in the document should be submitted for review as part of either:

  • The medical device license application data requirements listed in subsections 32(3) and (4) of the Regulations or
  • A request for post-market evidence as per section 39

This guidance does not apply to in vitro diagnostic (IVD) devices.


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