Jul 19, 2021
Canada
Health Canada, the country’s regulating authority in the sphere of medical devices and other healthcare products, has published a guidance document dedicated to medical device license applications for ultrasound diagnostic systems and transducers. The document...
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Jul 16, 2021
Canada
Health Canada, the country’s regulating authority in the sphere of medical devices and other healthcare products, has published a guidance document dedicated to the investigation of reported problems associated with medical devices. The latest version of the document...
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Jul 15, 2021
Canada
In last month’s #WebinarWednesday, Canadian regulatory expert Ana Subramanian discussed significant changes occurring this year with Canadian medical device regulations. The two most significant changes discussed were new requirements related to foreign risk...
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Jul 14, 2021
Canada
Health Canada, the country’s regulating authority in the sphere of medical devices, has published a guidance document dedicated to completing the application for a new medical device license or medical device license amendment for a private label medical device....
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Jul 8, 2021
Canada
Health Canada, the country’s regulating authority in the sphere of medical devices, has published a detailed guidance document describing the rules to be applied when determining the class of an in vitro diagnostic medical device (IVDD). The document provides an...
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Jul 6, 2021
Canada
Health Canada, the country’s regulating authority in the sphere of medical devices, has published a guidance document dedicated to incident reporting under the new regulatory framework, which becomes effective from June 23, 2021. The document provides additional...
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