COVID-19 guidance for reporting medical device shortages: When and how to report
Health Canada has made the medical device shortage reporting framework permanent by transitioning interim order provisions to the regulations. The interim order expired on March 1, 2022, at which time the new shortage reporting framework took effect. For more information, visit the Regulations amending certain regulations concerning drugs and medical devices (shortages): Notice
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When to report
The following 10 scenarios will help manufacturers and importers understand the timelines for reporting or updating shortage reports.
Scenario 1: A back-order of less than 30 days
- No shortage report is required.
Scenario 2: A back-order of more than 30 days
- A shortage report must be submitted within 5 business days from the day the manufacturer/importer is aware that a shortage is likely to occur and when the manufacturer responsible for reporting the shortage has no identified substitute device available in Canada.
Scenario 3: An initial back-order of less than 30 days is then extended to more than 30 days
- A shortage report must be submitted within 5 business days from the day the manufacturer/importer is aware that the back-order has been extended beyond 30 days and when the manufacturer responsible for reporting the shortage has no identified substitute device available in Canada.
Scenario 4: The manufacturer/importer's typical lead time is more than 30 days
- No shortage report is required.
Scenario 5: The typical lead time is more than 30 days and has been extended (back-ordered) by less than 30 days
- No shortage report is required.
Scenario 6: The manufacturer/importer's typical lead time is more than 30 days and has been extended (back-ordered) by 30 days or more
- A shortage report must be submitted within 5 business days from the day the manufacturer/importer is aware that the back-order has been extended beyond 30 days and when the manufacturer responsible for reporting the shortage has no identified substitute device available in Canada.
Scenario 7: The manufacturer/importer discovers a medical device is in shortage and hasn't anticipated the shortage
- A shortage report must be submitted within 5 business days from the day the shortage is identified and when the manufacturer responsible for reporting the shortage has no identified substitute device available in Canada.
Scenario 8: The manufacturer/importer becomes aware that a medical device for which it had already reported an anticipated shortage is now in shortage
- A shortage report update must be submitted within 2 business days from becoming aware of the shortage (must indicate the date the shortage began) and when the manufacturer responsible for reporting the shortage has no identified substitute device available in Canada.
Scenario 9: The information the manufacturer/importer submitted to Heath Canada about a medical device shortage has changed
- A shortage report update must be submitted within 2 business days of becoming aware of the change.
Scenario 10: The shortage for a medical device has ended
- An end-of-shortage report must be submitted within 2 business days from the day the manufacturer/importer is aware that the shortage has ended (include this date in the report as the end date for the shortage).
How to report
Manufacturers and importers must report actual or anticipated shortages for specified medical devices that are on the List of medical devices: Notification of shortages. These include devices authorized for importation or sale under another interim order made under section 30.1 of the Food and Drugs Act.
Health Canada updates the List of medical devices: Notification of shortages regularly. Manufacturers and importers are responsible for reviewing this list to ensure that they are submitting mandatory shortage reports for the required medical devices. Health Canada will not notify companies each time this list is updated.
To report an actual or an anticipated shortage, complete the following electronic reporting form and choose the Initial option under the 'Type of Report(s)' section at the start of the form:
To report a shortage status update or provide additional information, choose the Update option under the 'Type of Report(s)' section at the start of the reporting form.
At a minimum, the following information is required when submitting a medical device shortage report, update or final report to Health Canada:
- name and contact information for the manufacturer or the importer
- Medical Device Licence (MDL) number in the case of Class II, III or IV devices
- authorization identification number in the case of a device authorized for importation or sale under another interim order made under section 30.1 of the Food and Drugs Act
- device identifier
- includes the identifier of any medical device that is part of a system, test kit, medical device group, medical device family or device group family
- name of the device and of any component, accessory or part of the affected device, including the model name (if applicable) in both English and French
- description of the medical device, its packaging and an indication of whether it is a single-use device
- date on which the shortage began or is anticipated to begin
- date on which the manufacturer anticipates meeting the demand for the medical device, if known
One shortage reporting form may be used for multiple shortage reports as long as the devices being reported are from the same manufacturer. The form contains separate sections for reporting up to 10 device shortages.
The following information must be provided for each additional device:
- medical device licence number in the case of Class II, III or IV devices
- authorization identification number in the case of a device authorized for importation or sale under another interim order made under section 30.1 of the Food and Drugs Act
- device identifier
- includes the identifier of any medical device that is part of a system, test kit, medical device group, medical device family or device group family
- name of the device and of any component, accessory or part of the affected device, including the model name (if applicable) in both English and French
- date on which the shortage began or is anticipated to begin
- date on which the manufacturer anticipates meeting the demand for the medical device, if known
A shortage is resolved when:
- a manufacturer can once again meet current demand for the medical device and
- there are no anticipated shortages of the same medical device in the near future or
- an acceptable substitute option has been found by the manufacturer reporting the shortage
To report the end of a shortage, please complete the following form:
A manufacturer or importer may submit multiple end of shortage reports on a single reporting form as long as the devices being reported are from the same manufacturer.
If you are not sure whether to notify us about a shortage of a particular device, email us at MD.shortages-penurie.de.IM@canada.ca.
Once we receive a report that a shortage has ended, we will update the list of shortages to reflect this new information.
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