Drug and medical device post market surveillance

Health Canada collects and evaluates reports of suspected adverse reactions after products are approved for sale in Canada. These are undesirable effects potentially caused by health products.

We conduct risk assessments and recommend appropriate measures. These can include informing the public and health care professionals of new product safety information, recommending labelling changes, and removing a product from the market.

On this page:

• Detecting and assessing signals
• Risk management and intervention
• Advertising complaints for marketed health products

Detecting and assessing signals

Health Canada collects post-market information from a variety of sources. We evaluate the data to detect new safety signals that warrant more investigation.

In 2017, we received:

• 860,000 Post-Market Adverse Reaction Reports (over 132,000 Domestic, and 727,000 Foreign)
• 22,000 Medical Devices Incident Reports (20,600 Domestic)

We publish Summary Safety Reviews (SSRs) to inform Canadians of any safety investigation that might affect the health products they use.

In 2017, Health Canada reviewed 166 safety issues, resulting in 44 Summary Safety Reviews.

You can report adverse reactions and medical device incidents to your medical professional, to a hospital, or to the company that made the product. You can also report them to Health Canada through MedEffect Canada or by phone at 1-866-234-2345.

Risk management and intervention

Health Canada uses Risk Management Plans (RMPs) to enhance the quality of our evaluation. The RMP includes measures to be taken by a company to identify, prevent or minimize known or potential risks to patients.

In 2017, Health Canada reviewed 231 Risk Management Plans.

Once risks have been identified, the risk information is communicated to health care professionals and the public.

In 2017, Health Canada issued 137 Risk Communications to healthcare practitioners and Canadians. These risk communications can be searched in the Recalls and Safety Alerts Database.

Health Product Infowatch provides information about emerging health product safety risks to healthcare professionals, for use with their patients.

Advertising complaints for marketed health products

Health Canada regulates the advertising of marketed health products in Canada to ensure that companies are not making false claims about their products.

In 2017, Health Canada reviewed 67 advertising complaints related to health products. After reviewing a complaint we take appropriate action, which may include asking a company to stop selling and advertising an unapproved product.

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