Risk classification guide for medical device establishment inspections: Assigning a compliance rating
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
- Inspector's decision
- Situations that may produce a non-compliant rating
- Increasing the likelihood of a compliant rating
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 nature and extent of the deviations, deficiencies or failures the inspector sees during the inspection
- the record of compliance shown in previous inspections
- the procedures that have been developed and how well they have been applied
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:
- rates an observation as Risk 1
- sees any attempt by a company to deceive, misrepresent or falsify medical devices, records or documents (regardless of the classification of devices involved)
- deals with a company or representative who does not provide requested information (for example, records, labels)
- finds poor control over processes and operations including many Risk 2 observations
- finds 1 or several repeat observations
- finds actions inadequate to prevent deviations, deficiencies or failures from recurring
Increasing the likelihood of a compliant rating
Generally, a C rating will be assigned in the following situations:
- when few Risk 2 observations are noted (and are focused on isolated issues)
- when only Risk 3 observations are noted
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:
- correct the identified deficiency
- address the root cause that led to the deficiency to prevent it from happening again
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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