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

This version has been replaced by the GUI-0079v3 on December 9, 2022.

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.

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

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]

For assistance

Our service hours are Monday to Friday from 8 a.m. to 6 p.m. (local time) and closed statuary holidays.

By mail

Contact us by mail:

[Mail address]

Service standards: We answer to mail within 15 business days. If we can't answer your question right away. We will send you an estimate date.

Page details

Date modified: