Handling complaints about medical devices (GUI-0065): Overview
Version: 2
Date issued: December 24, 2025
Replaces: Guidance on Investigation of Reported Medical Device Problems, version 1 (March 25, 2011)
Disclaimer: This document does not constitute part of the Food and Drugs Act or its regulations, and in the event of any inconsistency or conflict between the Act or regulations and this document, the Act or the regulations take precedence. This document is an administrative document that is intended to facilitate compliance by the regulated party with the Act, the regulations, and the applicable administrative policies.
On this page
Purpose
This guidance document explains how to handle complaints about medical devices by developing effective procedures including how to:
- receive a complaint
- document a complaint
- investigate and respond to a complaint
- close a complaint
This guidance document will help industry comply with the requirements in the Medical Devices Regulations (regulations) by developing procedures to manage complaints.
Scope
This guidance document provides an interpretation of section 57 and paragraph 58(a) of the regulations (refer to the next section).
This document applies to:
- Class I to IV medical device manufacturers (including devices for investigational testing)
- private label manufacturers (Class II to IV medical devices)
- importers
- distributors
Note that a private label manufacturer is where:
- a company sells Class II, III or IV medical devices under their own name or trademark
- the medical device is made by another manufacturer that holds the original medical device licence
For conditions that must be met to sell medical devices made by another manufacturer under your own name or trademark, consult:
What the regulations say
Section 57 and paragraph 58(a) of the regulations specify what you must do to handle complaints:
- Subsection 57(1): The manufacturer, importer and distributor of a medical device shall each maintain records of the following:
- reported problems relating to the performance characteristics or safety of the device, including any consumer complaints, received by the manufacturer, importer or distributor after the device was first sold in Canada; and
- all actions taken by the manufacturer, importer or distributor in response to the problems referred to in paragraph(a)
- Paragraph 58(a): The manufacturer, importer and distributor of a medical device shall each establish and implement documented procedures that will enable them to carry out:
- an effective and timely investigation of the problems referred to in paragraph 57(1)(a)
Other sections of the regulations that apply are as follows:
- Paragraph 88(b) in Part 3 makes it clear that sections 57 and 58 also apply to manufacturers, importers and distributors of devices for investigational testing.
- Paragraph 45(g) says manufacturers, importers and distributors must attest that they have documented procedures in place to handle complaints when applying for a medical device establishment licence.
- Section 59 to subsection 61.1(2) outline the requirements for reporting incidents to Health Canada.
- Subsections 61.2(1) to 61.3(2) outline the requirements for reporting serious risk of injury to human health (or foreign risk notification) to Health Canada.
Both, incident reporting and foreign risk notification apply to manufacturers and importers. It's an essential step in identifying and monitoring of problematic devices within the Canadian marketplace.
- Sections 61.4 to 61.6, 68.31 to 68.33, subsection 25(1) and section 39 of the regulations refer to the preparation, retention and submission of summary reports as well as the completion of issue-related analyses of safety and effectiveness.
Learn about the criteria for how to determine what must be reported and when: