Guidance on medical device compliance and enforcement (GUI-0073): Overview

Effective date: December 14, 2024
Replaces: Guidance on Medical Device Compliance and Enforcement (GUI-0073), version 2 (June 12, 2015)

Disclaimer: This document does not constitute legislation. If there is any inconsistency or conflict between the legislation and this document, the legislation takes precedence. This document is an administrative document that is intended to facilitate compliance by the regulated party with the legislation and the applicable administrative policies.

On this page

• Purpose
• Scope
• Responsibilities
• Background

Purpose

This guideline describes how Health Canada conducts compliance and enforcement activities to ensure that the requirements in the Medical Devices Regulations (MDR) and sections of the Food and Drugs Act (act) applicable to medical devices are met.

Scope

This guide applies to any situation of non-compliance with the requirements of the MDR or a section of the act that concerns medical devices. The main sections of the MDR are listed in the section on relevant regulations.

Responsibilities

Regulated parties have mandatory responsibilities under the act according to the compliance and enforcement policy for health products. When a regulated party is notified of non-compliance, it is their responsibility to take timely and appropriate action to comply with the regulatory requirements.

If the action taken is considered inadequate to resolve the non-compliance, Health Canada may initiate compliance and enforcement actions based on the severity of risk to health posed by the non-compliance. The main objective of our enforcement actions is to mitigate the risk to health and safety associated with the regulatory non-compliance.

Under section 23 of the act, inspectors have certain powers related to verifying compliance with the act and the MDR, and to preventing non-compliance when there are reasonable grounds.

Background

Health Canada uses a risk-based compliance and enforcement approach. This approach is based on our:

• Compliance and enforcement policy framework and applicable policies
• Compliance and enforcement policy for health products (POL-0001)
• risk management approach
  • the process of identifying, assessing, evaluating, classifying and managing risk as part of compliance and enforcement activities