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National Rehabilitation Reporting Systematic Quality Documentation 20202021Production of this document is made possible by financial contributions from Health Canada and provincial and territorial
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FDA stands for Food and Drug Administration, a federal agency of the United States Department of Health and Human Services. Health Canada is the department of the Canadian government responsible for national public health.
Manufacturers, distributors, importers, and exporters of food, drugs, medical devices, and cosmetics are required to file with FDA and Health Canada.
The filing process for FDA and Health Canada involves submitting detailed information about the product, its ingredients, manufacturing process, labeling, and any reported adverse events.
The purpose of FDA and Health Canada is to regulate and ensure the safety, efficacy, and quality of food, drugs, medical devices, and cosmetics to protect public health.
Information regarding the product formulation, manufacturing process, labeling, adverse events, and any changes made to the product must be reported on FDA and Health Canada.
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