Risk classification guide for medical device establishment inspections (GUI-0079) - Summary
From the Regulatory Operations and Enforcement Branch
These guidelines describe how Health Canada inspectors rate deviations, deficiencies or failures and overall compliance found during an inspection of a medical device establishment.
Health Canada may inspect anyone who conducts activities under the Food and Drugs Act or the Medical Devices Regulations including companies exempted from having a MDEL. While the companies exempt from having a MDEL are not part of the current inspection cycle, they may be inspected when a risk or potential risk is identified.
Who this guide is for
- Class I medical device manufacturer
- Importer (class I-IV medical devices)
- Distributor (class I-IV medical devices)
In this guide
- 1. Purpose
- 2. Scope
- 3. Introduction
- 4. Determining the risk level of observations
- 5. Assigning a compliance rating
- 6. Disputing inspection results
- Appendix A - Sample observations and ratings
- Appendix B - Glossary
- Appendix C - References
Details and history
Published: [Month DD, YYYY]
Updated: May 18, 2015 (see all updates)
Consulted: [Month DD, YYYY] (see all consultations)
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