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How to Report — MedEffect Canada

MedEffect Canada​

Health Canada's MedEffect Canada portal is the primary system for submitting Mandatory Problem Reports (MPRs). It is also used for voluntary reporting by healthcare professionals and consumers.

Portal URL: canada.ca/medeffect

Who submits​

MPRs must be submitted by the regulated party (manufacturer, importer, or distributor) that is obligated to report. Typically this is the regulatory affairs or quality department.

What to include in an MPR​

A complete initial MPR should include:

Reporter information​

  • Company name, address, and contact details
  • Reporter name and title
  • Report date and reference number

Device information​

  • Device name and description
  • Device Licence number
  • Model and catalogue number
  • Lot/serial number(s) of the affected device(s)
  • Date of manufacture (if known)

Incident description​

  • Date the company became aware of the incident
  • Date of the incident (if known)
  • Description of what happened
  • Patient/user information (anonymised — initials, age, sex)
  • Clinical outcome (death, serious deterioration, near miss)

Initial assessment​

  • Whether the device appears to have malfunctioned or deteriorated
  • Initial hypothesis on cause (if known)
  • Actions taken or planned

Alternative submission​

MPRs can also be submitted by:

  • Email to Health Canada's Medical Devices Directorate (contact details on Health Canada website)
  • Fax (legacy method, still accepted)

Health Canada recommends using the MedEffect portal as the primary submission method.

Acknowledgement​

Health Canada acknowledges receipt of MPRs and assigns a reference number. This reference number should be used in all follow-up correspondence.

Official resource: MedEffect Canada