Authorization of medical devices for an urgent public health need: Overview
On this page
- About this framework
- How to obtain an authorization
- Authorized medical devices under Part 1.1
- Medical devices no longer authorized
About this framework
An urgent public health need exists if immediate action is required to protect or improve the health of individuals or communities in Canada.
The Minister may add a medical condition to the list of medical devices for an urgent public health need (UPHN list) if the Minister has reasonable grounds to believe that:
- the medical condition presents, or is the result of, a significant risk to public health in Canada and
- immediate action is required to deal with the risk
Except for an authorization for exceptional importation and sale, special access authorization and investigational testing authorization, no person in Canada shall import or sell a medical device unless they hold 1 of the following:
- a medical device establishment licence (MDEL) in the case of a Class I device
- the manufacturer, importer or distributor is on the list of active MDELs and is authorized to import or sell Class I medical devices
- a medical device licence (MDL) in the case of a Class II, III or IV device
- the device is included in the Medical Devices Active Licence Listing
- an authorization for a medical device under Part 1.1
- the device is included in the list of authorized medical devices
How to obtain an authorization
A manufacturer may only submit a new application for authorization for the following medical device under Part 1.1 of the Medical Devices Regulations (MDR):
- a medical device set out in Part 1 of the UPHN list or
- a medical device that belongs to a category of medical devices set out in Part 2 of the UPHN list
Manufacturers wishing to import or sell a medical device that is not on the UPHN list must use the licensing pathway under Part 1 of the MDR to obtain:
- a medical device establishment licence (Class I)
- a medical device licence (Class II to IV)
To obtain an MDEL or MDL under Part 1 of the MDR, consult the following guidance documents:
- Guidance on medical device establishment licensing (GUI-0016) - Summary
- How to complete the application for a new medical device licence
For information on who can apply and how to submit an application for authorization, consult the following guidance document:
Authorized medical devices under Part 1.1
List of authorized medical devices under Part 1.1 of the MDR
Only medical devices authorized by Health Canada can be imported or sold in Canada. Medical devices on this list are authorized under Part 1.1 of the MDR.
Access the latest version of the list:
For information on how to obtain an authorization, consult the following guidance document:
List of medical devices for expanded use
Some medical devices are granted an expanded use indication. For these devices, the Minister has reasonable grounds to believe there is an urgent public health need for the expanded use of the device for the corresponding medical condition. Health Canada maintains the list of medical devices for expanded use and updates it as required. The list is incorporated by reference in the MDR.
Access the latest version of the list:
For information on how medical devices are granted an expanded use indication, consult the following guidance document:
Medical devices no longer authorized
List of medical devices no longer authorized
New devices may be added to this list as required.
It is important for health care providers and other users to check this list regularly for products that are no longer authorized.
Access the latest version of this list:
For more information, consult the following guidance document:
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