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.

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: [Month DD, YYYY]

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.

Report a problem or mistake on this page
Please select all that apply:

Thank you for your help!

You will not receive a reply. For enquiries, contact us.

Date modified: