Risk classification guide for medical device establishment inspections: Disputing inspection results
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.
Companies may report concerns to Health Canada if they disagree with:
- the inspection rating
- any of the content in the inspection report
To report any disagreement, you must:
- contact the Manager of Medical Devices Inspections within 5 business days after receiving your inspection report
- contact information is in the cover letter for your inspection report
- provide in writing the reason for the disagreement, along with the specific sections of the report identified as an issue and any applicable supportive information
The Manager of Medical Device Inspections will acknowledge receipt of your disagreement within 10 business days.
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