May 18, 2022 updates to list of medical devices for mandatory shortage and discontinuation reporting

MDEL Bulletin May 18, 2022, from the Medical Devices Compliance Program

On this page

• Reporting shortages and discontinuations of specified medical devices
• Reporting shortages and discontinuations of other medical devices
• Forms for reporting
• Contact us

Reporting shortages and discontinuations of specified medical devices

Health Canada has updated the List of Medical Devices – Notification of Shortages on May 18, 2022, to add and remove medical devices that require mandatory reporting by manufacturers and importers.

We have recently removed the following medical devices from the list, as these no longer require mandatory reporting:

Class I medical devices:

• KN95 respirators for medical use
• Face shields
• Chemotherapy gowns

 Class II medical devices:

• Infrared thermometers
• Digital thermometers
• Pulse oximeters (single measurement)
• Manual pulmonary resuscitators

 Class III medical devices:

• Pulse oximeters (continuous monitoring)
• Dialyzers
• Infusion pumps

 Class IV medical devices:

• Extracorporeal Membrane Oxygenation (ECMO) devices

We have also added the following medical devices to the list, as these do require mandatory reporting:

Class III medical devices:

• Defibrillators

Health Canada maintains and regularly updates this list, which is incorporated by reference (IBR) into the Medical Devices Regulations.

Manufacturers of Class I to IV devices and importers of Class I medical devices should check the list of medical devices regularly. As stated in sections 62.23 to 62.25 of the Regulations, you must report shortages and discontinuations of specified medical devices to Health Canada. A medical device also includes its components, accessories or parts.

For more information on medical device shortage reporting, please refer to the:

• medical device shortages web page
• Guide to reporting medical device shortages and discontinuations (GUI-0137)

Reporting shortages and discontinuations of other medical devices

Manufacturers and importers are also encouraged to report shortages and discontinuations for medical devices not found on the List of Medical Devices – Notification of Shortages.

We encourage voluntary reporting when:

• the shortage is likely to create a patient or user safety issue in Canada
• a substitute device, component, accessory or part is not readily available
• the shortage is national in scope

Forms for reporting

To report shortages (including voluntary shortage reports), complete the electronic shortages reporting form.

To report discontinuations that will lead to a shortage (including voluntary discontinuation reports), complete the electronic discontinuation reporting form.

Contact us

For inquiries, please contact us by email at MD.shortages.penurie.de.IM@hc-sc.gc.ca.