Health Product Complaint Form (FRM-0317)
There are 2 different forms for submitting a complaint depending on the type of health product involved:
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
- 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
- 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
- For all health product complaints (except medical devices) access online form.
Note: 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).
Note: 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
Note: Assisted Human Reproduction (AHR) material and activities
If you are reporting a complaint related to material subject to the Assisted Human Reproduction Act or its regulations, including
- donor sperm used for the purpose of AHR
- donor ova used for the purpose of AHR
- in vitro embryos
or related to activities subject to the Assisted Human Reproduction Act or its regulations, including
- providing consent for the use of donated human reproductive material for the purpose of creating an embryo
- processing donor sperm or ova for the purpose of AHR
- distributing donor sperm or ova for the purpose of AHR
- making use of donor sperm or ova for the purpose of AHR
- importing donor sperm or ova for the purpose of AHR
- reimbursing surrogate mothers for expenditures and loss of work-related income
- reimbursing sperm and ova donors for expenditures
- reimbursing persons for expenditures related to the maintenance or transport of an in vitro embryo
please submit your complaint including your contact information to email@example.com
- For medical devices complaints only complete the form below.
Note: Medical device industry representatives
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
Privacy Notice Statement
Provision of the information requested on this form is voluntary.
Personal information is collected under the authority of the Food and Drugs Act and the Privacy Act for the purpose of delivering national compliance and enforcement activities of health products under the Inspectorate's mandate. Failure to provide personal information may affect Health Canada's ability to effectively meet this purpose.
Your personal information when disclosed to the Inspectorate is confidential and protected. This information is administered and retained in accordance with the Food and Drugs Act and is protected as personal information under the Privacy Act, and in the case of an access to information request, under the Access to Information Act. Your personal information is stored and maintained in an appropriate database and / or filed in accordance with the department's best practices.
You have the right to access your personal information and request changes if the information is incorrect. Details on personal information collected under this program are outlined on the Info Sources Web site and are described in the Health Canada section (see Personal Information Bank(s) - HC PPU 405, 406, 407, and 408).
Questions or comments regarding the administration of the Privacy Act in our Department may be directed to the Health Canada's Access to Information and Privacy Coordinator. For additional information on privacy issues and the Privacy Act in general, consult the Office of the Privacy Commissioner of Canada or call 1 (800) 282-1376 or (613) 947-1698.
Online Form - (Medical Devices Only) - FRM-0317
Protected A (when completed)
Type of Health Product: Medical Devices
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