COVID-19 guidance for reporting medical device shortages: When and how to report

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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

Scenario 2: A back-order of more than 30 days

Scenario 3: An initial back-order of less than 30 days is then extended to more than 30 days

Scenario 4: The manufacturer/importer's typical lead time is more than 30 days

Scenario 5: The typical lead time is more than 30 days and has been extended (back-ordered) by less than 30 days

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

Scenario 7: The manufacturer/importer discovers a medical device is in shortage and hasn't anticipated the shortage

Scenario 8: The manufacturer/importer becomes aware that a medical device for which it had already reported an anticipated shortage is now in shortage

Scenario 9: The information the manufacturer/importer submitted to Heath Canada about a medical device shortage has changed

Scenario 10: The shortage for a medical device has ended

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:

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:

A shortage is resolved when:

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 hc.meddev-matmed.sc@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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