Catalogue - Canadian Urban Data Catalogue (CUDC)

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Catalogue Entry: Guidance to market authorization holders on issuing health product risk...

Guidance to market authorization holders on issuing health product risk communications: Definitions.
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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 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...
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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 thereâ€™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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2,942 catalogue entries found