Mandatory reporting requirements for hospitals

Reporting requirements of serious adverse drug reactions and medical device incidents for hospitals.

On this page

• Regulatory requirements for hospitals
• Which hospitals must report
• Why and what to report
• When and how to submit reports
• Serious adverse drug reactions and medical device incidents summary statistics

Regulatory requirements for hospitals

Hospitals are required to report all serious adverse drug reactions (ADRs) and medical device incidents (MDIs), according to the following regulatory requirements:

• Food and Drug Regulations for adverse drug reactions
• Medical Devices Regulations for medical device incidents

Which hospitals must report

The mandatory reporting regulatory requirements apply to hospitals that are:

• licensed, approved or designated as a hospital by a province or territory to provide care or treatment
• operated by the Government of Canada and provide health services to in-patients

Why and what to report

Why report

Canada's monitoring of therapeutic products plays an important role in public health and patient safety.

Hospitals help make health products safer by reporting serious adverse drug reactions and medical device incidents. Reports of serious ADRs and MDIs:

• promote the safe use of health products by people in Canada
• may be the first sign of previously unrecognized rare or serious ADRs or MDIs
• help Canada take action against products that may pose a risk to health and safety

What to report

The mandatory reporting requirements for hospitals apply to the following therapeutic products:

• prescription and non-prescription drugs
• medical devices
• disinfectants
• biologic drugs, such as:
  • vaccines (except those administered under a routine immunization program of a province or territory)
  • plasma proteins
  • biotechnology products
  • fractionated blood products
• radiopharmaceutical drugs
• drugs for an urgent public health need
• drugs obtained through the block release regulations

Hospitals are not required to report on:

• semen and ova
• cells, tissues and organs
• blood and blood components
• vaccines administered under a routine immunization program of a province or territory
• natural health products
• drugs and devices used under the Special Access Program for drugs, for clinical trials or investigational testing for medical devices

When in doubt, Health Canada encourages hospitals to report.

When and how to submit reports

Mandatory reporting by hospitals must be submitted in writing within 30 days of the serious ADR or MDI being documented. We encourage hospitals to report sooner if possible.

For information on how to report a serious ADR or MDI, please see Report an adverse reaction or medical device problem.

Serious adverse drug reactions and medical device incidents summary statistics

When a serious ADR or MDI is documented in a hospital, the hospital must submit a report to Health Canada within 30 calendar days. Health Canada monitors these reports in the interest of public health and patient safety.

We have statistics that give a monthly summary of serious ADRs and MDIs reported by Canadian hospitals.

Check out our summary statistics.

Related links

• Government of Canada's health products post-market surveillance cycle
• New products for serious adverse drug reaction hospital reporting: Notice
• Mandatory reporting by hospitals of serious adverse drug reactions related to biocides - Notice
• Mandatory reporting of serious adverse drug reactions and medical device incidents by hospitals - Poster
• Subscribe to Health Canada’s newsletter on mandatory reporting
• Mandatory reporting of serious adverse drug reactions and medical device incidents by hospitals - Guidance