SOR/98-282 › Medical Devices Regulations (Canada)
Medical Devices Regulations (Canada)
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.
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.
This document comes with our free Notification Service, good for the life of the document.
This document is available in either Paper or PDF format.
Customers who bought this document also bought:ASTM-D4169
Standard Practice for Performance Testing of Shipping Containers and Systems
Food and Drugs
Medical devices - Quality management systems - Requirements for regulatory purposes
Dec. 16, 2019