Archive 1: Risk classification guide for medical device establishment inspections (GUI-0079) - Summary

From the Regulatory Operations and Enforcement Branch

Overview

These guidelines describe how Health Canada inspectors rate deviations, deficiencies or failures and overall compliance found during an inspection of a medical device establishment.

Important notice

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

1. Class I medical device manufacturer
2. Importer (class I-IV medical devices)
3. Distributor (class I-IV medical devices)

In this guide

• 1. Purpose
• 2. Scope
• 3. Introduction
  • Three levels of risk for observations
  • Compliant and non-compliant ratings
• 4. Determining the risk level of observations
  • Repeat observations
• 5. Assigning a compliance rating
  • Situations that may produce a non-compliant rating
  • Increasing the likelihood of a compliant rating
• 6. Disputing inspection results
• Appendix A - Sample observations and ratings
  • Food and Drugs Act (FDA)
  • Medical Devices Regulations (MDR) Part I – General
  • MDR Part 2 – Custom-made devices and medical devices to be imported or sold for special access
  • MDR Part 3 – Medical devices for investigational testing involving human subjects
  • MDR Part 4 – Export certificates
• Appendix B - Glossary
• Appendix C - References

View complete guide
Download PDF (414KB, 23 pages)

Details and history

Published: January 31, 2020

Updated: May 18, 2015 (see all updates)

Consulted: [Month DD, YYYY] (see all consultations)

Part of topic(s): Guidance on legislation, [other relevant topic or content]

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