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Found 10 records similar to Mandatory reporting of serious adverse drug reactions and medical device incidents by hospitals - Overview

Federal

This is a public health concern resulting in significant costs to the health care system as well as individual impacts on Canadians. Health Canada's monitoring of therapeutic product safety plays a vital role in public health and patient safety, providing health care providers and patients with the most up-to-date knowledge for decision making. It also provides Health Canada with information needed to monitor the benefit-risk ratio of products and act to protect Canadians where appropriate.

Last Updated: Oct. 21, 2022
Date Published: Aug. 11, 2020
Organization: Health Canada
Formats: HTML
Keywords:  mandatory reporting, reporting of serious-adverse-drug-reactions, reporting of serious-adverse-medical-device-incidents, reporting by hospitals
Federal

Reports about serious ADRs and MDIs can be important signals of emerging safety issues. Such post-market observations can also lead to improved safety information about a product.

Last Updated: Oct. 21, 2022
Date Published: Jan. 28, 2020
Organization: Health Canada
Formats: HTML
Keywords:  reports about serious-ADRs, reports about serious-MDIs, emerging safety issues, post-market observations, improved safety information, adverse-reaction reporting, mandatory adverse-reaction reporting
Federal

The Regulations Amending Certain Regulations Concerning Drugs and Medical Devices (Shortages) were made on September 1st, 2021. They amend the Food and Drug Regulations and Medical Devices Regulations and are published in Canada Gazette, Part II.

Last Updated: Sep. 24, 2021
Date Published: Sep. 1, 2021
Organization: Health Canada
Formats: HTML
Keywords:  drug regulations, medical devices regulation, amending certain regulations, drugs shortages, medical devices shortages
Federal

Reporting requirements of serious adverse drug reactions and medical device incidents for hospitals.

Last Updated: Oct. 21, 2022
Date Published: Nov. 15, 2021
Organization: Health Canada
Formats: HTML
Keywords:  mandatory reporting-requirements, reporting-requirements for hospitals, reporting-requirements of serious-adverse-drug-reactions, reporting-requirements of serious-medical-device-incidents
Federal

Instructions on completing the mandatory adverse reaction reporting form for industry

Last Updated: Oct. 21, 2022
Date Published: Nov. 30, 2020
Organization: Health Canada
Formats: HTML
Keywords:  adverse-reaction reporting, mandatory adverse-reaction reporting, reporting-form for industry
Federal

Health Canada's Medical Devices Regulations regulate traditional devices effectively. New technologies, such as software as a medical device, need more flexibility in our regulatory oversight.

Last Updated: Jun. 7, 2022
Date Published: Feb. 24, 2022
Organization: Health Canada
Formats: HTML
Keywords:  regulatory-innovation for health-products, agile-licensing for medical-devices, medical-devices regulations, new technologies, software as medical-device
Federal

"Health Canada appreciates the critical role health professionals in Canada play in identifying, reporting and managing potential cases of COVID-19 and recognizes the pressures a surge in people requiring medical care can cause on facilities.

In light of the current situation, Health Canada is clarifying expectations regarding the requirement for hospitals to report medical device incidents (MDIs) and serious adverse drug reactions (ADRs) during the COVID-19 pandemic."

Last Updated: Apr. 7, 2020
Date Published: Mar. 23, 2020
Organization: Health Canada
Formats: HTML
Keywords:  Notice for Hospitals, COVID-19 outbreak, pandemic
Federal

Health Canada is making regulatory changes to the Medical Devices Regulations to strengthen the lifecycle approach to the regulation of medical devices by increasing post-market surveillance authorities.

Last Updated: Oct. 21, 2022
Date Published: Sep. 14, 2021
Organization: Health Canada
Formats: HTML
Keywords:  Medical Devices Regulations, regulatory changes, new regulations, post-market surveillance, risk management
Federal

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 familiar with database structures and setting up their own queries. Find details on the data structure required for the data file in the Canada Vigilance Adverse Reaction Online Database - Data Structure. In order to use the data, the file must be loaded into an existing database or information system provided by the user.

Last Updated: Jan. 31, 2022
Date Published: Feb. 12, 2009
Organization: Health Canada
Formats: XML JSON other HTML ZIP
Keywords:  online database, suspected adverse reactions, drugs, health products, prescription, non-prescription medication, natural health products, radiopharmaceuticals, canada vigilance program
Federal

Instructions on Completing the Mandatory Medical Device Problem Reporting Form

Last Updated: Oct. 21, 2022
Date Published: Apr. 10, 2018
Organization: Health Canada
Formats: HTML
Keywords:  adverse-reaction reporting, mandatory adverse-reaction reporting, reporting-form for industry, medical-device problem reporting
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