Work performed in Canada on US patients using US device

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SSchoepel

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My assumption is that clinicians doing work in Canada would need a device that is cleared by Health Canada, but I thought I'd ask this anyway just in case the answer is different than that:
Do you need Health Canada clearance for clinicians in Canada to perform diagnostic evaluation of US patients using a SaMD that resides in the US, houses the data and interface in the US, and is cleared in the US? (The clinicians are employed by a Canadian clinical out-sourcing company.)
 
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