Health Product Complaint

There are 2 different forms for submitting a complaint depending on the type of health product involved:

For Medical Devices

If you are a consumer looking to report a problem with a medical device, access this online form.

If you are an industry representative, looking to file a complaint about a competitor's medical device or report a problem not covered by mandatory reporting requirements, access this online form.

If you represent a company whose device is linked to an incident and qualifies as a Mandatory Problem Report, please use Mandatory Medical Device Problem Reporting Form for Industry

For all health product complaints (except medical devices) access the online form.

  • Quick-Reference Chart for Health Product Complaints
    • Type of Health Products
      • Blood and blood components
      • Cells, tissues, organs
      • Clinical trial study for health products
      • Donor semen
      • Drugs (Animal use)
      • Drugs (Human use including biologics)
      • Medical devices
      • Natural health products
      • Xenografts
    • Complaint (examples)
      • Health Product quality (such as a medication having a foul odor)
      • Labelling errors
      • Health Product mix-ups, incorrect components, particulate matter, foreign materials, contamination etc.
      • Unapproved / unauthorised sale and/or advertising (e.g. no product licence, unapproved health claims etc.)
      • Sale of unlicensed products on the internet
      • Tampering/Sabotage
      • Concerns about the safety of a device or its ability to perform as claimed
      • Violation of the Food and Drugs Act and associated Regulations by a Competitor
      • Clinical trials complaints
      • Counterfeit products
  • Cells, tissues and organs (CTO) establishments

    If you are reporting an error and / or accident involving human cells, tissues and organs for transplantation, please use Human Cells, Tissues and Organs for Transplantation - Error or Accident Investigation Preliminary Report Form (FRM-0172).

  • Blood Establishments

    If you are reporting an error and / or accident involving blood collected for transfusion or for use in the manufacture of a drug for human use, please use FRM-0337

  • Assisted Human Reproduction (AHR) material and activities

    If you are reporting a complaint related to assisted human reproduction (AHR) materials, activities or any matters subject to the Assisted Human Reproduction Act or its Regulations please complete the Complaint form for the Assisted Human Reproduction Act.

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

Thank you for your help!

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

Date modified: