Report a medical device problem: hospital, health care facility, health care provider

On this page

• Who can report and how
• Report a medical device incident: mandatory
• Report a medical device problem: voluntary options
• Report an investigational testing authorization: mandatory
• Report an incident through the Special Access Program: mandatory

Who can report and how

You can report a problem or incident with a medical device if you’re a:

• hospital
  • licensed, approved or designated by a province or territory to provide care or treatment
  • operated by the federal government to provide health care to inpatients
• health care facility (or group of facilities with a common management)
  • provides diagnostic or therapeutic services to patients
• health care provider
  • a person, such as a doctor, nurse practitioner, midwife or radiologist
  • an entity, such as a lab, hospital, urgent care clinic or medical supply company

There are 2 ways to report a problem or incident with a medical device, regardless of the device type or its risk class.

The first way is through a mandatory reporting system. Here, the health care provider or facility is legally required to report medical device incidents in certain circumstances.

This requirement to report is stated in the Medical Device Regulations.

The second way is through a voluntary reporting system. Health Canada encourages voluntary reporting of all medical device problems to ensure that appropriate actions are taken by the company to address any non-compliance based on the risk to health. Here, the person reporting does so without any legal or administrative requirement to do so.

Report a medical device incident: mandatory

Hospitals must report serious medical device incidents to Health Canada in writing, within 30 days of documenting the incident. This mandatory reporting requirement applies to the hospital rather than the health care providers who work there. However, health care providers may report for the hospital.

To report:

• choose “Mandatory report from hospital” in Section A (report and submitter information)
• complete the online form or download the electronic PDF form and submit by fax or mail

Report a hospital medical device incident

You can also report through the secure file transfer protocol (sFTP). To do so, contact the Canada Vigilance Program.

Learn more:

• Mandatory reporting of serious adverse drug reactions and medical device incidents by hospitals

Report a medical device problem: voluntary options

Hospitals, health care facilities and health care providers may voluntarily report problems with a medical device that do not meet the threshold for an incident. This threshold is outlined in section 62 of the regulations.

You may submit a voluntary report to the Medical Device Compliance Verification Unit of Health Canada’s Regulatory Operations and Enforcement Branch.

Report a medical device problem

Learn more about the compliance and enforcement actions that apply to medical devices:

• Compliance and enforcement of medical devices

For members of the Canadian Medical Devices Sentinel Network

The Canadian Medical Devices Sentinel Network (CMDSNet) is a surveillance program that provides complementary data for post-market evaluations to enhance medical device safety. Health care facilities that are members of CMDSNet use the network to report medical device problems.

If you’re a health care provider, you can report a problem on behalf of a member facility directly to Health Canada.

To report:

• choose “Voluntary report from CMDSNet” in Section A (report and submitter information)
• complete the online form or download the electronic PDF form and submit by email ( cmdsnet-resscmm@hc-sc.gc.ca), fax or mail

Report a CMDSNet report

You can also report through the secure file transfer protocol (sFTP). To do so, contact the Canada Vigilance Program.

Report an investigational testing incident: mandatory

Qualified investigators affiliated with a hospital or health care facility who conduct investigational testing of medical devices must report serious adverse incidents. Reporting must be made to Health Canada and to the manufacturer or importer within 72 hours of learning about the incident.

To report:

• choose “Mandatory report for ITA” in Section A (report and submitter information)
• complete the online form or download the electronic PDF form and submit by fax or mail

Report a mandatory ITA incident

Learn more about reporting ITA incidents:

• Applications for medical device investigational testing authorizations

Report an incident through the Special Access Program: mandatory

If a medical device authorized under the Special Access Program has caused a serious adverse event, you must report to Health Canada and to the device manufacturer or importer within 72 hours after the incident has taken place.

To report:

• choose “Mandatory report for SAP” in Section A (report and submitter information).
• complete the online form or download the electronic PDF form and submit by fax or mail

Report a mandatory SAP incident

Learn more about reporting SAP incidents:

• Health Canada's special access programs: Request access to a medical device

Related links

• Medical devices
• MedEffect Canada
• Advisories, warnings and recalls
• Medical device incidents database
• Medical devices establishment licence listing
• Medical Devices Active Licence Listing (MDALL)
• Education modules to meet requirements for mandatory hospital reporting
• Case study on adverse reactions to drugs and problems with medical devices
• Mandatory reporting of serious adverse drug reactions and medical device incidents by hospitals