Guidance on Medical Device Establishment Licensing (GUI-0016) - Summary

From Health Canada’s Regulatory Operations and Enforcement Branch

In light of COVID-19, please only email any completed MDEL application forms, amendments and/or notifications to the MDEL application email account at: We are unable to process any mailed in application forms at this time.


This document provides guidance on regulatory requirements in relation to medical device establishment licence (MDEL), such as when and how to apply for an MDEL, as well as how to maintain it once it is issued.

Who this guide is for

  1. Importers or distributors of medical devices into Canada for human use.
  2. Manufacturers of Class I medical devices for human use in Canada.

In this guide

Change summary

Guidance has been updated to incorporate the applicable sections of the amended Medical Device Regulations, subsection 44 (3) and (4) and paragraph 45 (j).

Guidance has been updated to incorporate information related to the new Fees in Respect of Drugs and Medical Devices Order.

View complete guide

Download PDF (734 KB, 42 pages)

Details and history

April 1, 2020

Last updated: April 1, 2013
December 1, 2012

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