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Canada Releases Final Guidance on Software as a Medical Device

January 2, 2020

Health Canada has finalized guidance on software as a medical device (SaMD) that clarifies how it fits into the agency’s regulatory framework and how devicemakers can comply.

The classification of SaMD is based on the intended use and on the existing classifications  in Canada’s medical device regulations, ranging from low-risk Class I to high-risk Class IV.

Devicemakers must first determine the software’s risk class, which will be confirmed by the agency’s Medical Devices Bureau when it reviews the application. Software does not meet the SaMD definition if it is just used to drive a hardware medical device.

The agency called the guidance “the first step of SaMD policy in Canada,” and promised to update its policy as the technology evolves.

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