Draft Guidance Document: Applications for Medical Device Investigational Testing Authorizations

This draft guidance document reflects Health Canada’s current thinking on Investigational Testing Authorizations (ITA) for medical devices and may be subject to changes as policy develops. The document clarifies application requirements and processes, including pre-ITA meetings, format for an ITA application and filing requests for revisions to an ITA.

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Applications for Medical Device Investigational Testing Authorizations Guidance Document

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