Risk classification guide for medical device establishment inspections (GUI-0079) (effective December 14, 2026): Overview
This document is for reference only. It will not come into effect until December 14, 2026. For the current version, refer to Risk classification guide for medical device establishment inspections (GUI-0079).
Replaces version 4 of Risk classification guide for medical device establishment inspections (GUI-0079), released on November 21, 2025
Disclaimer: This document doesn’t 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’s intended to help the regulated party comply with the legislation and the applicable administrative policies.
On this page
- Purpose
- Scope
- Introduction
- Three levels of risk for observations
- Compliant and non-compliant ratings
Purpose
This document will help ensure consistency among Health Canada inspectors during medical device establishment inspections when:
- classifying observations of deficiencies according to risk
- assigning an overall compliance rating to an inspection
It will also help medical device establishments know which situations Health Canada considers unacceptable and which may result in a non-compliant rating, compliance and enforcement actions, or both.
Scope
These guidelines apply to any medical device establishment inspected under the authority of the Food and Drugs Act (the act) and the Medical Devices Regulations (the regulations).
For details about which medical device establishments are inspected and the inspection process, consult:
Introduction
Health Canada may inspect anyone who conducts activities under the act or the regulations.
Health Canada inspectors carry out inspections that support the national compliance and enforcement program.
During an inspection, the inspector will:
- verify how you comply with the sections of the act and the regulations that apply to you
- confirm that your written procedures are established, implemented and maintained, as well as adequate in meeting the requirements in the act and the regulations
- document deficiencies as observations in an inspection report
- rate these observations by their level of risk
- issue your establishment a compliant or non-compliant rating based on these observations
- recommend that terms and conditions be added or amended on your establishment licence, if applicable
Three levels of risk for observations
During an inspection, the inspector will assign a risk classification to each observation ranging from 1 for higher risk issues to 3 for lower risk issues. The 3 levels of risk are:
- Risk 1 (critical), where the situation:
- is likely to result in an immediate or underlying health or safety risk or
- involves any effort by a person to deceive, misrepresent or falsify medical devices or records
- Risk 2 (major), where the situation:
- involves a failure to meet the requirements of the act and regulations for manufacturing, importing or distributing medical devices and
- involves a remote chance of an immediate health and safety risk because processes or procedures are in place to reduce the risk
- Risk 3 (minor), where the situation:
- has low or minor impact on the safety of people in Canada using medical devices or
- is not critical (Risk 1) or major (Risk 2)
Refer to Sample observations and ratings for examples of how inspectors may rate the failure to meet all or part of specific sections of the act or regulations.
Compliant and non-compliant ratings
Based on the observations noted and taking into account the nature and extent of the deficiencies, the inspector assigns an overall inspection rating for the establishment.
The possible inspection ratings are:
- C (compliant): At the time of the inspection, the regulated party has demonstrated the activities it conducts are in compliance with the act and the regulations. A "C" rating doesn’t mean there are no observations or that corrective actions are not required.
- NC (non-compliant): At the time of the inspection, the regulated party has not demonstrated the activities it conducts are in compliance with the act and the regulations.
Regardless of whether the rating is compliant or non-compliant, Health Canada may apply terms and conditions to the establishment licence to help protect the health and safety of people in Canada.
A non-compliant rating may have serious consequences, as outlined in the Compliance and Enforcement Policy for Health Products (POL-0001). These can include:
- stopping the sale of devices
- recalling devices
- stopping the importation of devices
- seizing devices
- issuing an inspector order or warning letter
- suspending an establishment licence
- prosecuting the company
- adding new terms and conditions to the establishment licence
Note: If you receive a non-compliant rating and there is an immediate risk to health, Health Canada will take action to enforce compliance with the act and the associated regulations.