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Jurisdiction Definition Legislation Australia A medical device that: (a) is made specifically in accordance with a request by a health professional specifying the design characteristics or construction of the medical device; and (b) is intended: (i) to be used only in relation to a particular individual; or (ii) to be used by the health professional to meet special needs arising in the course ...
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, ... Health Canada; I. IEC 60601; IEC 62304; IEC 62366; ISO 10993;
Canada's emergency legislation on the coronavirus crisis gives the health minister powers to circumvent patent law and ensure medical supplies, medication or vaccines can be produced locally. The ...
Health Canada's Medical Devices Directorate is transitioning from the ALARP standard to AFAP ("As Far As Possible") in the regulation of risk of medical devices. [11] [12] The ALARP concept can be interpreted to promote financial consideration in higher regard than of the requirements of safety and performance of medical devices [citation ...
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 Compliance and Enforcement Directorate provides support to Health Canada by enforcing the laws and regulations pertaining to the production, distribution, importation, sale, and/or use of consumer products, including but not limited to: tobacco, pest control materials, drugs and medical devices, biologics, and natural health products.
The Health Products and Food Branch (HPFB) of Health Canada manages the health-related risks and benefits of health products and food by minimizing risk factors while maximizing the safety provided by the regulatory system and providing information to Canadians so they can make healthy, informed decisions about their health.
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