Health Canada

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 added to ensure the continued monitoring of risks after a product is authorized for sale in Canada.

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 requirements in the Regulations were added to ensure the continued monitoring of benefits and risks after a product is...

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 added to ensure the continued monitoring of risks after a product is authorized for sale in Canada.

Guidance to market authorization holders on issuing health product risk communications: Definitions.

The purpose of this document is to assist market authorization holders (MAHs) develop and disseminate health product risk communications (HPRCs).

The timeline to develop and disseminate an HPRC should be based on an assessment of the risk associated with a health product.

2011 Health Canada brochure

This strategy document outlines the steps to be taken in order to optimize the use of RWE to improve the safety and effectiveness of medical devices across the product life cycle. As well, the plan describes the activities and the outputs required to achieve the objectives.

An adverse reaction or side effect is a harmful and unintended response to a health product. The reaction occurs at doses normally used.

Health Canada makes sure that the known serious risks are written on the product label or product monograph, as well as provides information on how to manage these risks, so that patients and/or health professionals can make informed choices.

A medical device is any instrument or component used to treat, diagnose or prevent a human disease or abnormal physical condition. Page about what medical device problems are and how to report them.

MedEffect™ Canada provides a simple and efficient means for health professionals to report an adverse reaction to the Canada Vigilance Program. It also serves as a centralized point to access the latest health product safety information such as advisories and recalls.

Health Canada information related to adverse reaction reporting of drugs and health products on the Canadian market

Health product advertising directly or indirectly promotes the sale or use of any health product. This can be done by any means including: print, Internet, and broadcast. Only health products that have been authorized for sale by Health Canada may legally be advertised in Canada.

The Recalls and Safety Alerts Database provides easy access to a comprehensive list of recalls, advisories, and safety alerts. This database includes recalls from Health Canada, the Canadian Food Inspection Agency, and Transport Canada.

The Recalls and Safety Alerts Database provides easy access to a comprehensive list of recalls, advisories, and safety alerts. This database includes recalls from Health Canada, the Canadian Food Inspection Agency, and Transport Canada.

The Canada Vigilance Program collects and assesses reports of suspected adverse reactions to marketed health products in Canada, including prescription and non-prescription medications; natural health products; biologically derived products such as vaccines and fractionated blood products; cells,...

The intent of this notice is to clarify Health Canada’s expectations with respect to the re-reporting of cases identified from the Canada Vigilance (CV) Online Database by Market Authorization Holders (MAHs). In particular, this clarifies section 4.3 of the May 2018 update to the Reporting...

The data set is updated on a monthly basis and currently covers the following time period: 1965 to 2023-10-31. The data extract is a series of compressed ASCII text files of the full data set contained in the Canada Vigilance Adverse Reaction Online Database. It is intended for users who are...

Hospitals must report all serious adverse drug reactions (ADRs) and medical device incidents (MDIs).