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Scope

Abstract

The Canadian Medical Devices Regulations (SOR/98-282) apply to the manufacturing, sale, advertising for sale, and importation of medical devices, including in vitro diagnostic devices.  Manufacturers selling medical devices in Canada must ensure that their medical devices meet the safety and effectiveness requirements as defined in this regulation.

Notes

Claudia's Notes:
The Canadian Medical Devices Regulations are issued under the authority of the Canadian Food and Drug Act.  Updates appear regularly, so be sure to keep an eye on this particular document if it is applicable to your business.

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