Risk classification guide for medical device establishment inspections: Determining the risk level of observations

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.

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Criteria used to rate observations

Inspectors use the following criteria to rate observations noted during inspections:

The inspector will immediately bring any observation rated as Risk 1, along with any other observations requiring immediate corrective action, to the company's attention.

Repeat observations

An observation may be designated as a "repeat observation" if an observation made during a previous inspection has either:

If only part of an observation is repeated, it may be designated as a "partial repeat observation".

The inspector may rate a repeated deviation, deficiency or failure at a higher risk level than it was first rated.

Rating the risk level of repeat observations

The inspector will consider the following questions when rating a repeat or partial repeat observation:

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