Risk classification guide for medical device establishment inspections (GUI-0079): Disputing inspection results
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 Inspection 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 Devices Inspection will acknowledge receipt of your disagreement within 10 business days.