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Found 10 records similar to Mandatory reporting of serious adverse drug reactions and medical device incidents by hospitals - Overview
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.
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.
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.
Reporting requirements of serious adverse drug reactions and medical device incidents for hospitals.
Instructions on completing the mandatory adverse reaction reporting form for industry
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.
"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."
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.
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.
Instructions on Completing the Mandatory Medical Device Problem Reporting Form