Risk classification guide for medical device establishment inspections: Assigning a compliance rating

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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Inspector's decision

An inspector's decision to rate a company as compliant (C) or non-compliant (NC) with the Act and Regulations takes into account the following factors:

The inspector will advise the company of the rating at the inspection closing meeting.

For more information, please refer to the section on the inspection process in the "About inspections" tabbed page of the following guidance document:

Situations that may produce a non-compliant rating

An NC rating may result if an inspector finds any of the following situations:

Increasing the likelihood of a compliant rating

Generally, a C rating will be assigned in the following situations:

The actions an establishment takes during an inspection can also affect its compliance rating. The likelihood of getting a compliant rating increases if immediate action is taken to address observations rated as Risk 1 and any Risk 2 observation(s) that may contribute to an NC rating.

When an inspector notes any issue that could lead to an NC rating, the company must take immediate corrective actions that will:

The inspector will assess if the company can demonstrate that the Risk 1 (critical) and Risk 2 (major) observations that contributed to the NC rating have been resolved before the end of the closing meeting. If this can be demonstrated, the inspector may consider changing the overall inspection rating to a C rating.

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