On November 15, 2022, Health Canada released a new guidance document, “Guidance on clinical evidence requirements for medical devices.” In this document, Health Canada provides guidance on clinical evidence requirements for Class II, III, and IV medical devices. This document does not apply to in vitro diagnostic devices (IVDDs).
The document includes guidance on when clinical data/evidence is required, methods to generate and evaluate clinical data, and how to compare devices appropriately. It also provides general principles and criteria for clinical evidence that supports amending licence applications, and additional obligations during the post-market phase.
Health Canada also released a companion document, “Examples of clinical evidence requirements for medical devices,” which contains examples of different types of devices and outlines when clinical evidence is more likely or less likely to be required.
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