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Catalogue Entry: Guidance on summary reports and issue-related analyses for medical devices: Overview
This guidance document was prepared to help medical device manufacturers understand and comply with sections 25, 39 and 61.4 to 61.6 of the Medical Devices Regulations. Two new...-
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Catalogue Entry: Guidance on summary reports and issue-related analyses for medical devices:...
This guidance document was prepared to help medical device manufacturers understand and comply with the Medical Devices Regulations. Two new requirements in the Regulations were...-
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Catalogue Entry: Guidance on distinction between advertising and other activities for health...
Health Canada recognizes that it is important for industry to disseminate non-promotional, accessible information on human and animal health products to health care...-
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Catalogue Entry: Guidance Document - Submission of Risk Management Plan and Follow-up Commitments
The objective of this guidance document is to assist industry and interested stakeholders (Market Authorization Holders (MAHs)) in developing a Risk Management Plan and Follow-...-
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Catalogue Entry: Guidance Document - Health Canada and Advertising Preclearance Agencies'...
Health Canada and the Canadian Advertising Preclearance Agencies (APAs) share the common goal of maintaining integrity in health product advertising. The purpose of this... -
Catalogue Entry: Foreign risk notification for medical devices guidance document: What, when...
Information needed for a submission to comply with the Regulations, licence holders and/or importers of Class II to IV medical devices-
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Catalogue Entry: Foreign risk notification for medical devices guidance document:...
Medical device licence holders and importers of Class II to IV devices must notify Health Canada when there’s a serious risk of injury to human health concerning a device...-
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Catalogue Entry: Foreign risk notification for medical devices guidance document: Monitoring,...
Requirements for manufacturers and importers for collecting medical device safety information and provide notification to Health Canada. A monitoring process should be in place...-
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Catalogue Entry: Foreign risk notification for medical devices guidance document: Background
This guidance document is to help holders of Canadian authorizations for medical devices understand and comply with the regulatory requirements on foreign risk notification (FRN).-
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Catalogue Entry: Health Canada’s Action Plan on Medical Devices: Continuously Improving...
Despite the strong foundation of Canada’s existing Regulations, more can be done to improve the safety and effectiveness of medical devices and to optimize health outcomes for...-
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Catalogue Entry: Guidance to market authorization holders on issuing health product risk...
In Canada, many different organizations and individuals play a role in communicating risks associated with health products.-
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Catalogue Entry: Health Product InfoWatch: February 2024
The following is a list of health product advisories, type I drug recalls and summaries of completed safety reviews published in January 2024 by Health Canada.-
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Catalogue Entry: Health Product InfoWatch: January 2024
The following is a list of health product advisories, type I drug recalls and summaries of completed safety reviews published in December 2023 by Health Canada.-
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Catalogue Entry: Health Product InfoWatch: December 2023
The following is a list of health product advisories, type I drug recalls and summaries of completed safety reviews published in November 2023 by Health Canada.-
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Catalogue Entry: Health Product InfoWatch: November 2023
The following is a list of health product advisories, type I drug recalls and summaries of completed safety reviews published in October 2023 by Health Canada.-
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Catalogue Entry: Health Product InfoWatch: October 2023
The following is a list of health product advisories, type I drug recalls and summaries of completed safety reviews published in September 2023 by Health Canada.-
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Catalogue Entry: Health Product InfoWatch: September 2023
The following is a list of health product advisories, type I drug recalls and summaries of completed safety reviews published in August 2023 by Health Canada.-
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Catalogue Entry: The advertising preclearance system
To ensure that advertising material meets Canadian regulatory standards for advertisements for drugs and medical devices, advertising preclearance agencies (APAs) provide review...-
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Catalogue Entry: Adverse reactions, medical device incidents and health product recalls in...
Each year, Health Canada receives thousands of reports of suspected adverse reactions (side effects) about drugs and natural health products and of suspected medical device...-
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Catalogue Entry: Submitting risk management plans draft guidance document: Canadian-specific...
A Canadian-specific addendum should address: risks or uncertainties that are unique to the Canadian context, and measures that the manufacturer intends to take that are unique...-
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