Report an adverse reaction or medical device problem

Reporting adverse reactions and medical device problems by consumers, health professionals and regulated parties, including industry and hospitals.

On this page

What are adverse reactions and medical device problems

An adverse reaction is a noxious and unintended effect to a health product.

A medical device problem is related to:

  • inadequate labelling or instructions for use
  • a failure of the device or a deterioration in its effectiveness
  • an actual or potential deficiency that may affect product performance or safety

Consumers and health professionals: voluntary reporting

Anyone can report an adverse reaction or medical device problem. Your report can help make health products safer for all Canadians.

Consumers include:

  • general public
  • patients
  • caregivers

Health professionals include:

  • nurses
  • physicians
  • pharmacists
  • biomedical engineers

As a voluntary reporter, you are encouraged to report adverse reactions from a wide range of health products, such as:

  • biologics:
    • vaccines
    • biotechnology products
    • fractionated blood products
    • transplanted human cells, tissues and organs
    • human blood and blood components following a transfusion
  • prescription and non-prescription pharmaceuticals
  • natural health products
  • radiopharmaceuticals
  • disinfectants and sanitizers with disinfectant claims

You are also encouraged to report medical device problems from a wide range of medical devices, such as:

  • needles
  • syringes
  • pacemakers
  • blood glucose meters
  • insulin and infusion pumps

You should report an adverse reaction or medical device problem as soon as possible after the reaction or problem occurred. You should do this even if you:

  • do not have specific details or
  • are not sure if a particular health product was the cause

Voluntary reporting: how to report an adverse reaction or medical device problem

For health products, other than immunization vaccines and medical devices

When reporting an adverse reaction, you may find it helpful to consult with a health care professional first, who:

  • may be able to offer information that could be useful to the assessment of your report
  • may wish to submit their own report to Health Canada

Guidance documents:

Report adverse reactions directly to Health Canada.

Complete the form below:

Report a side effect

or

Submit by:

For immunization vaccines

Guidance for health care professionals and the general public:

For medical devices

Institutions that are part of the Canadian Medical Devices Sentinel Network (CMDSNet) should report voluntary incidents:

Please download form to your desktop before filling out.

Medical device problem report form

Submit by:

  • Fax: Download, print and complete the applicable form and fax it to 1-866-678-6789.
  • Mail: Download, print and complete the applicable form:

Consumers, health professionals and facilities that do not participate in CMDSNet are also encouraged to voluntarily report medical device problems:

For more information see:

Complete the form:

Health product complaint form

Industry, hospitals and other regulated parties: mandatory reporting

Canada's Food and Drugs Act and Regulations set out specific reporting requirements and timelines for mandatory reports. These require regulated parties to report adverse reactions and medical device problems. There are also new mandatory requirements for hospitals.

Regulated parties include:

  • industry, such as:
    • importers
    • distributors
    • manufacturers
    • natural health product licensees
    • market authorization holders
  • hospitals
  • drug clinical trial sponsors
  • qualified investigators conducting investigational testing for devices
  • practitioners requesting special access for medical devices
  • other regulated parties, such as:
    • blood transfusion establishments
    • source establishments for human cells, tissues and organs

Mandatory reporting: how to report an adverse reaction or medical device problem

Industry: for drugs, natural health products, cells, tissues and organs

Guidance document:

Complete one of the forms below:

CIOMS adverse reaction reporting form

or

Mandatory Adverse Reaction Reporting Form for Industry

Submit by:

  • Electronically: The Canada Vigilance Program accepts electronic reports from enrolled trading partners. The Trading Partner Management Office (TPMO) provides a single point of contact for trading partners already enrolled with Canada Vigilance Program to submit adverse reactions electronically as well as for market authorization holders (MAHs) seeking enrolment. Contact the TPMO at tpmo_bgpc@hc-sc.gc.ca to obtain the guidance document on e-reporting and/or to enrol.
  • Fax to 613-957-0335.
  • Mail to the Canada Vigilance National Office.

Hospitals: for serious adverse drug reactions and medical device incidents

On December 16, 2019, there will be new mandatory requirements for hospitals. Hospitals must report, in writing, within 30 days of when a serious adverse drug reaction or medical device incident is first documented. We encourage hospitals to report sooner, if possible.

Guidance document:

Until December 15, 2019, continue to submit reports using the online reporting application

Starting December 16, 2019, complete your report using one of the following forms:

Please download form to your desktop before filling out.

Hospital adverse drug reaction form

Medical device problem report form

Submit by:

Establishments involved in the transplantation of human cells, tissues and organs

Source and non-source establishments must comply with the regulatory requirements in the Safety of Human Cells, Tissues and Organs for Transplantation Regulations. Source establishments must also meet section 51 requirements for reporting adverse reactions to Health Canada through the Canada Vigilance Program.

Guidance document:

Complete the form below:

Mandatory adverse reaction reporting form for industry

Submit by:

  • Fax to 613-957-0335.

Establishments involved in activities related to the transfusion of blood and blood components

The Blood Regulations, including sections 110 to 116, have requirements about investigation and reporting of adverse reaction in recipients. Establishments that must meet these requirements are those that either:

  • import blood for transfusion or
  • process, label, distribute, transform or store blood for transfusion or for further manufacture

Guidance document:

Complete the form below or use a form of your choice, as long as it meets regulatory obligations:

Mandatory adverse reaction reporting form for industry

Submit by:

  • Fax to 613-957-0335.

Industry: for medical devices

Guidance document:

Complete the form:

Mandatory medical device problem form for industry

Submit by:

Health care professionals: for Special Access Program (medical devices) and investigational testing (medical devices)

Guidance document:

Complete the form:

Please download form to your desktop before filling out.

Medical device problem report form

Submit by:

  • Fax: Download, print and complete the applicable form and fax it to 1-866-678-6789.
  • Mail: Download, print and complete the applicable form:

For more information about mandatory reporting of serious adverse drug reactions and medical device incidents:

Related services and information

Related Act and regulations

Report a problem or mistake on this page
Please select all that apply:

Thank you for your help!

You will not receive a reply. For enquiries, contact us.

Date modified: