Health products post-market surveillance cycle

Recognize

• All health products have risks and benefits associated with their use.
• Drug and medical device safety knowledge and issues evolve over time. New risks can become evident once a product is used by broader populations, for longer durations and under different conditions than those studied before being approved for sale.
• Side effects and complications are known as adverse reactions (ARs) and medical device incidents (MDIs). Health Canada monitors ARs and MDIs to keep up-to-date on new information related to the safety and effectiveness of health products.

Report

• Anyone can report ARs and MDIs.
• Health care providers and consumers report voluntarily. Market authorization holders (manufacturers and distributors) and hospitals must report under the Food and Drugs Act.

Collect

• AR and MDI reports are entered into the Canada Vigilance Adverse Reaction Online Database and the Medical Devices Incident Database.
• These databases allow users to search for AR and MDI reports

Analyse

• We look at AR and MDI reports received and other sources of product-related safety information, such as:
  • pre-market trials and tests
  • medical and scientific literature
  • additional reports from manufacturers
  • information from foreign regulatory agencies
• We carefully assess the available safety information to look for a possible cause-effect link between the health product and the AR or MDI.

Act

• When Health Canada identifies new safety issues, we take action. We use the most appropriate level of intervention to manage the risks and help people in Canada make informed decisions.
• We may:
  • continue to monitor safety information
  • reassess at a future date if new information becomes available
  • ask the manufacturer to supply additional post-market safety and effectiveness information
  • request post-market tests and studies
  • restrict access to and distribution of the drug or device
  • update the product label
  • issue a risk communication
  • withdraw from the market the drug or device
• We also monitor and respond to advertising complaints to ensure that companies don't make false and misleading claims, or engage in illegal marketing of health products.

Communicate

• We let people in Canada know about safety information in several ways:
  • Recalls and safety advisories
  • Summary safety reviews
  • Health Product InfoWatch (monthly safety bulletin)
  • Advertising complaints database
• You can also look up information for specific drugs or medical devices through our:
  • Canada Vigilance Adverse Reaction Online Database
  • Medical Devices Incident Database
  • Drug and Health Product Portal

If you experience an AR or MDI with a drug or a medical device, we want to hear from you.

Report to Health Canada