Health Canada has developed a series of research tools. These tools assess the extent a group of individuals are following Canada’s food guide: Healthy Eating Food Index...
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This guidance document applies to drugs regulated under Part C, Division 1 of the Regulations that have received a DIN pursuant to Section C.01.014.2. This includes...
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This guidance document provides medical device stakeholders with information on the requirements that the Therapeutics Products Directorate will use in recognizing Auditing...
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A growing number of Canadians are using medical test kits in their homes to diagnose or monitor certain health conditions. These test kits are considered to be medical devices....
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Health Canada has successfully completed the transition to the Medical Device Single Audit Program (MDSAP). All manufacturers holding medical device licences in Canada now...
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The term Medical Devices, as defined in the Food and Drugs Act, covers a wide range of health or medical instruments used in the treatment, mitigation, diagnosis or prevention...
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Medical batteries are medical devices and are regulated under the Food and Drugs Act and Medical Devices Regulations. The Act and Regulations govern the import, advertising and...
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The purpose of this document is to recommend international standards for, and promote harmonisation of, the nonclinical safety studies recommended to support human clinical...
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This list represents substances and formulations which have been assessed by the Therapeutic Products Directorate on the basis of an application to market or further to...
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The List of Drugs for an Urgent Public Health Need (the List) contains the following drug-related details: the brand name, the medicinal ingredient(s), the route of...
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This labelling standard applies to ethylene oxide products labelled for use as gaseous sporicides in sterilizing medical instruments/devices. It does not apply to any other...
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Animal-sourced insulins and biosynthetic (man-made) human insulins are used worldwide for managing diabetes. Recently, some concern has been expressed about the overall safety...
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This guidance has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process....
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While hyperbaric oxygen therapy is recognized as an effective treatment for 14 specific conditions listed below, the operators of some private clinics claim it can also be used...
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Through the special access program (SAP) for medical devices, health care professionals can access custom-made and unlicensed medical devices for patients under their care.
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