Adverse Reaction and Medical Device Problem Reporting

Consumers/patients and health professionals can report adverse reactions (also known as side effects) to health products, including prescription and non-prescription medications, biologics, natural health products and radiopharmaceuticals, to the Canada Vigilance Program.

• Reporting by Consumers
• Reporting by Health Professionals
• Reporting by Industry
• Reporting Adverse Reactions to Other Products
• Adverse Reaction Reporting Information
• Related Documents

Reporting by Consumers

Reporting for Health Products (except Medical Devices)

• Mail
  Download and print the Consumer Side Effect Reporting Form and the postage paid label. Complete the form and mail it to a Canada Vigilance Regional Office, using the postage paid label.
• Online
  Complete a report online.
• Fax
  Download and print the Consumer Side Effect Reporting Form.
  Complete the form and send it by fax at 1-866-678-6789.
• Telephone
  Call a Canada Vigilance Regional Office at 1-866-234-2345 (toll-free).

Reporting for Medical Devices

• Consumers are encouraged to report device-related incidents directly to Health Canada by completing a Medical Device Problem Report.

Note to consumers:
Consumers are encouraged to consult their health professional who could offer additional information that may be useful in reporting a side effect.

Reporting by Health Professionals

Reporting for Health Products (except Medical Devices)

• Telephone
  Call a Canada Vigilance Regional Office at 1-866-234-2345 (toll-free).
• Fax
  Download and print the Canada Vigilance Adverse Reaction Reporting Form.
  Complete the form and send it by fax at 1-866-678-6789.
• Mail
  Download and print the Canada Vigilance Adverse Reaction Reporting Form and the postage paid label.
  Complete the form and mail it to a Canada Vigilance Regional Office, using the postage paid label.
• Online
  Complete a report online.

Reporting for Medical Devices

• Health professionals are encouraged to report device-related incidents directly to Health Canada by completing a Medical Device Problem Report.

Reporting by Industry

According to Canada's  Food and Drugs Act, it is mandatory for Market Authorization Holders (MAH) (manufacturers and distributors) and for source establishments of human cells, tissues and organs to submit adverse reaction reports to Health Canada, as well as, it is mandatory for manufacturers and importers to submit medical device problems reports to Health Canada. Additional information on the regulatory requirements related to adverse reaction reporting can be found in the Guidance Documents and Guidelines section of the Reports and Publications - MedEffect™ Canada page.

Reporting for Drugs

Market Authorization Holders (manufacturers and distributors) must submit reports to the Canada Vigilance National Office by:

• Mail
  Download one of the following forms:
  •  Council for International Organizations of Medical Sciences (CIOMS) I Form (preferred form).
    or
  • Mandatory Adverse Reaction Reporting Form for Industry.

  Complete the form and mail it to the Canada Vigilance National Office.

• Fax
  Download one of the following forms:
  •  Council for International Organizations of Medical Sciences (CIOMS) I Form (preferred form).
    or
  • Mandatory Adverse Reaction Reporting Form for Industry.

  Complete the form and send it by fax at 613-957-0335.

Reporting for Natural Health Products or Cells, Tissues and Organs

Market Authorization Holders for Natural Health Products or Cell, Tissue and Organ (CTO) Source Establishments must submit reports to the Canada Vigilance National Office by:

• Mail
  • Download the Mandatory Adverse Reaction Reporting Form for Industry.
  • Complete the form and mail it to the Canada Vigilance National Office.
• Fax
  • Download the Mandatory Adverse Reaction Reporting Form for Industry.
  • Complete the form and send it by fax at 613-957-0335.

Reporting for Medical Devices

Manufacturers and importers of medical devices must submit report to the Canada Vigilance - Medical Device Problem Reporting Program by:

• Email
  Download the Mandatory Medical Device Problem Reporting Form for Industry.
  Complete the form and email it to mdpr@hc-sc.gc.ca
• Fax
  Download the Mandatory Medical Device Problem Reporting Form for Industry.
  Complete the form and send it by fax at 613-954-0941.
• Mail/Courier
  Download the Mandatory Medical Device Problem Reporting Form for Industry.
  Complete the form and mail it to the Canada Vigilance - Medical Device Problem Reporting Program.

If you require further assistance, contact the Canada Vigilance National Office.

Reporting Adverse Reactions to Other Products

To report an adverse reaction to cosmetics, medical devices, pesticides, veterinary drugs, consumer products, foods or any other product on the Canadian market, visit the Adverse Reaction Reporting for Specific Products for details on how to submit an adverse reaction report.

Related Documents

Consumers

• Patient Guide for Reporting Side Effects
• Reporting Side Effects from Your Medicine: What you need to know - Guidebook

Health Professionals

• Adverse Reaction Reporting and Health Product Safety Information - Guide for Health Professionals

Industry

• Guidance Document for Mandatory Problem Reporting for Medical Devices
• Notice to Industry to change procedures for the reporting of Adverse Events Following Immunization (AEFI) and Periodic Safety Update Reports (PSURs) for vaccines
• Guidance Document for Industry - Reporting Adverse Reactions to Marketed Health Products
• Guidance Document for Source Establishments - Reporting Adverse Reactions to Human Cells, Tissues and Organs