Risk classification guide for medical device establishment inspections (GUI-0079): Introduction
Version: 3
Date issued: December 9, 2022
Replaces: Risk classification guide for medical device establishment inspections, version 2 (January 31, 2020)
Disclaimer: This document does not constitute legislation. In the event of 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
- Introduction
- Three levels of risk for observations
- Compliant and non-compliant ratings
Purpose
This document is intended to help ensure consistency among Health Canada inspectors during medical device establishment inspections when:
- classifying observations of deviations, deficiencies or failures according to risk
- assigning an overall compliance rating to an inspection
It also informs medical device establishments of situations Health Canada considers unacceptable and which may result in a non-compliant rating and/or compliance and enforcement actions.
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 the following document:
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 Regulations that apply to you
- confirm that your written procedures are adequate and determine whether you are following them
- write down deviations, deficiencies or failures 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
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 regarding the manufacturing, importation and/or distribution of 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 Canadians 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 deviations, deficiencies and/or failures, 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 that the activities it conducts are in compliance with the Act and its associated regulations. A "C" rating does not mean that there are no observations or corrective actions are not required.
- NC (non-compliant): At the time of the inspection, the regulated party has not demonstrated that the activities it conducts are in compliance with the Act and its associated regulations.
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
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 Regulations.