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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.
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;
In Canada, custom-made medical devices are subject to Part 2 of the Medical Devices Regulations (SOR/98-282) [2] under the Food and Drugs Act. Serious adverse incidents with medical devices must be reported to Health Canada within 72 hours.
Prior to being given market authorization, a manufacturer must present substantive scientific evidence of a product's safety, efficacy, and quality as required by the Food and Drugs Act and Regulations. [1] It is one of the ten operational directorates of the Health Products and Food Branch, a branch of Health Canada.
In August, 2009, Health Canada which is responsible for regulating the advertising, manufacturing and sale of medical devices in Canada issued a notice confirming that patient management software is a medical device and is subject to the Medical Devices Regulations and the Food and Drugs Act.
Health Canada has stated "The Natural Health Product Regulations, introduced in 2004, will continue to operate the same way under Bill C-51. Canadians will continue to have access to natural health products that are safe, effective and of high quality. [5] In spite of this claim, The Natural Health Industry remained skeptical.
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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 ...
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related to: health canada medical device regulations