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Health Canada (HC; French: Santé Canada, SC) [NB 1] is the department of the Government of Canada responsible for national health policy. The department itself is also responsible for numerous federal health-related agencies, including the Canadian Food Inspection Agency (CFIA) and the Public Health Agency of Canada (PHAC), among others.
EpiCeram obtained Health Canada medical device license in September 2009 and was distributed by Pediapharm. It was sold under prescription in Canada as a Class II medical device until October 2018, when Health Canada revoked EpiCeram's authorization for sale in Canada.
MDSAP is a program that allows the conduct of a single regulatory audit of a medical device manufacturer’s quality management system that satisfies the requirements of multiple regulatory jurisdictions, including Canada and the U.S. A final regulatory decision on a DrugSorb-ATR MDL is expected from Health Canada in 2025.
The Medical Devices Bureau of Health Canada recognizes four classes of medical devices based on the level of control necessary to assure the safety and effectiveness of the device. Class I devices present the lowest potential risk and do not require a licence.
The Marketed Health Products Directorate (MHPD) is the Canadian federal authority that monitors the safety and effectiveness of health products marketed in Canada. These include: [1] Prescription and non-prescription medications; Biologic medical products, including fractionated blood products; Therapeutic and diagnostic vaccines; Natural ...
The Global Harmonization Task Force (GHTF) was “a voluntary group of representatives from national medical device regulatory authorities (such as the U.S. Food and Drug Administration (FDA)) and the members of the medical device industry” [1] whose goal was the standardization of medical device regulation across the world.
Medical Devices regulations cover all the topics related to the laws, standards or submissions process, with which compliance is required by manifold national and international bodies to commercialize a medical device
A medical tricorder is a handheld [1] portable [2] scanning device to be used by consumers [3] to self-diagnose medical conditions [4] within seconds [3] and take basic vital measurements. While the device is not yet on the mass market, there are numerous reports of other scientists and inventors also working to create such a device as well as ...