Guidance on releasing information from adverse reaction and medical device incident reports to the public: Procedure for releasing information

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Procedures for releasing different types of information

The Health Products and Food Branch (HPFB) and Regulatory Operations and Enforcement Branch (ROEB) have different procedures for providing adverse reaction (AR) and medical device incident (MDI) data.

Information available on the Health Canada website

You can access a subset of the information from post-market domestic adverse reaction reports for health products approved for use in humans through the Canada Vigilance Adverse Reaction Online Database. The Marketed Health Product Directorate (MHPD) updates this database monthly to include data from 1965 up to that received 3 months prior to the update.

You can access medical device incident reports available to the public through the Medical Device Incidents database.

Information from post-market adverse reaction reporting programs in standard summary formats

The programs will only provide adverse reaction information from post-market domestic adverse reaction and medical device incident reports. You can request information from:

Requests for information should include:

You can make requests for standard summary formats of adverse reaction data in writing (letter, fax or email) to the:

Canada Vigilance Program
Health Products Surveillance and Epidemiology Bureau
Marketed Health Products Directorate
Health Products and Food Branch
Health Canada
Postal Locator 1908C
Ottawa, Ontario K1A 0K9
Telephone: 1-866-234-2345
Fax: 1-866-678-6789
Email: canada.vigilance@hc-sc.gc.ca

Medical Devices Compliance Program
Medical Devices and Clinical Compliance Directorate
Regulatory Operations and Enforcement Branch
Health Canada
Email: meddev-matmed@hc-sc.gc.ca
Medical Devices Compliance Program website

Pharmacovigilance Program
Clinical Evaluation Division
Veterinary Drugs Directorate
Health Canada
Postal Locator 3106D
Ottawa, Ontario K1A 0K9
Telephone: 1-877-838-7322
Fax: 613-946-1125
Email: pv-vet@hc-sc.gc.ca

Non-standard information

You can request information other than what is publicly available or represented in standard summary format reports. This includes:

You may request this information under the Access to Information Act (ATIA) and pay the applicable fee using the online request system:

ATIP online request

Be sure to include the adverse reaction report number or medical device incident number for copies of reports.

Information from foreign regulatory agencies

You can request data received from foreign regulatory agencies from the responsible regulatory agency.

Protected information

Protected information includes both personal information and confidential third-party information.

Personal information

Personal information is defined in the Privacy Act (the Act) as “information about an identifiable individual that is recorded in any form (section 3). The Act protects personal information related to an identifiable patient, device user, animal/owner and/or reporter of the adverse reaction or medical device incident. The Canadian Charter of Rights and Freedoms (the Charter) and other applicable laws may also protect this information.

We will not provide information in standard summary format for requests where the search criteria selected include patient or reporter identifiers such as:

These identifiers increase the risk of re-identification of the patient or reporter.

Confidential third-party information

For the purposes of this procedure, "third-party" means any person, group of persons or organization other than the person requesting the information or a government institution listed in Schedule 1 of the ATIA.

Health Canada holds confidential third-party information for various purposes. Having received such information in confidence, it has a duty to uphold its confidentiality in accordance with the applicable laws. The Charter also protects third-party information for which there is a reasonable expectation of privacy.

In circumstances where third-party information is requested pursuant to the ATIAsome types are, or can be, protected against release. This includes:

Limitations and interpretation of information

There are limitations to both the adverse reaction reports and the medical device incidents.

Adverse reaction reports

You should take the limitations of information from adverse reaction reports, described here, into consideration when interpreting adverse reaction data.

This summary is based on raw data from information provided on adverse reaction reports submitted to Health Canada:

Each report represents the suspicion, opinion or observation of the individual reporter and does not necessarily mean the suspected health product(s) caused the reaction. The information is based on a spontaneous reporting system that is suitable to detect signals of potential health product safety issues during the post-market period. The data have been collected by a spontaneous surveillance system in which adverse reactions to health products are reported to Health Canada either:

Under-reporting of adverse reactions is seen with both voluntary and mandatory spontaneous surveillance systems. You should not use accumulated case reports to determine the incidence of a reaction or to estimate risk for a particular product because we don’t know the:

Because of the multiple factors that influence reporting, quantitative comparisons of health product safety cannot be made from the data. Some of these factors include:

In some cases, the reported clinical data is incomplete and there is no certainty that these health products caused the reported reactions. A given reaction may be due to an underlying disease process or to another coincidental factor. We provide this information with the understanding that the data will be appropriately referenced and used in conjunction with this caveat statement.

Medical device incidents

The information in the Medical Devices Incidents database is based on raw data provided on medical device incident reports submitted by manufacturers or importers directly to Health Canada. Each report represents the suspicion, opinion or observation of the individual reporter and does not necessarily mean the suspected health product(s) caused the incident. The data have been collected by a spontaneous surveillance system in which medical device incidents are reported to Health Canada:

Not all medical device incidents are reported to manufacturers or importers. Reporting may be influenced by multiple factors, including:

For these reasons, accumulated case reports should not be used as a basis to estimate risk nor do they represent all know safety information concerning the device(s) and should not be known on their own to make decisions about the use of these devices. We provide this information with the understanding that the data will be appropriately referenced and used with this caveat statement.

How you can use the information from adverse reaction reporting programs in Health Products and Food Branch or Regulatory Operations and Enforcement Branch

You may use the adverse reaction or medical device incident data provided by reporting programs of the HPFB in other documents, including publications. We ask that you:

Requests by the media

Representatives from the media who wish to request information or specific issues relating to an adverse reaction or a medical device incident should contact the Health Canada-Media Relations Unit:

Health Canada - Media Relations Unit
Communications and Public Affairs Branch Health Canada
Postal Locator 0912C
Ottawa, Ontario K1A 0K9
Telephone: 613-957-2983
Fax: 613-952-7747
Email: cpab.media.relations-relations.avec.les.media.sdgcap@hc-sc.gc.ca

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