Guidance on Medical Device Establishment Licensing (GUI-0016) - Summary
- Apply for a medical device establishment licences (MDEL)
- Submit using MDEL application form (FRM-0292)
Related guides and help
- Medical device establishment licence application: form and instructions (FRM-0292)
- Guidance document – Fees for the Review of Medical Device Establishment Licence Applications
- Medical Devices Active Licence Listing
- Medical Devices Establishment Licence Listing
- How to Pay Your Establishment License Fees
Related acts and regulations
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: email@example.com. 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
- Importers or distributors of medical devices into Canada for human use.
- Manufacturers of Class I medical devices for human use in Canada.
In this guide
- About this document
- Getting and managing your establishment licence
- Types of MDEL applications
- Applying for an MDEL
- Submitting your Annual Licence Review (ALR) application
- Updating or cancelling your MDEL
- Steps to take if your MDEL is suspended or cancelled by Health Canada
- Additional regulatory requirements of an MDEL holder
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.
Download PDF (734 KB, 42 pages)
Details and history
April 1, 2020
Last updated: April 1, 2013
December 1, 2012
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