Draft guidance for reporting medical device shortages: When and how to report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 shortage scenarios illustrate how to report shortages and discontinuations in a variety of situations and describe manufacturer and importer reporting obligations.
Scenario 1: A manufacturer also manufactures a substitute medical device, component, accessory or part that can be substituted for the device in shortage and is able to meet the demand for it in Canada
No shortage report is required (subsection 62.23(9))
Scenario 2: A back-order of less than 30 calendar days
Examples:
- A manufacturer/importer is unable to meet the demand for a specified medical device and anticipates being able to meet demand in 14 days. After 14 days, the manufacturer is once again able to meet demand.
- A manufacturer/importer is unable to meet the demand for a specified medical device and anticipates being able to meet demand in 14 days. This timeline is extended by 10 days. After 24 days, the manufacturer is once again able to meet demand.
- A manufacturer/importer's typical delivery time for a specified medical device is 40 days and the delivery time increases by an additional 25 days.
No shortage report is required (subsection 62.23(7))
Scenario 3: A back-order of more than 30 calendar days
Examples:
- A manufacturer/importer is having issues with sterilizing a specified medical device and anticipates that it will take 45 days to sterilize the device to meet demand.
- A manufacturer/importer's typical delivery time for a specified medical device is 40 days and the delivery time increases by an additional 35 days.
A shortage report must be submitted:
- within 5 business days from the day the manufacturer/importer is informed that the back-order will be more than 30 calendar days and
- when the manufacturer responsible for reporting the shortage has no identified substitute device available in Canada (subsection 62.23(8))
Scenario 4: An initial back-order of less than 30 calendar days is extended to more than 30 calendar days
Example:
- A manufacturer/importer is unable to meet the demand for a specified medical device and anticipates being able to meet demand in 14 days. This timeline is extended to 40 days.
A shortage report must be submitted:
- within 5 business days from the day the manufacturer importer is aware that the back-order will cause a shortage longer than 30 calendar days (subsection 62.23(8)) and
- when the manufacturer responsible for reporting the shortage has no identified substitute device available in Canada (subsection 62.23(9))
Scenario 5: A 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 (subsections 62.23(4) and (9))
Scenario 6: A 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) (subsection 62.23 (5))
Scenario 7: The information a manufacturer/importer submitted to Heath Canada about a medical device shortage has changed
Example:
- A manufacturer/importer reported a shortage and learned the end date for the shortage has changed from the original date provided to Health Canada.
A shortage report update must be submitted within 2 business days of becoming aware of the change (subsection 62.23(5)).
Scenario 8: The shortage for a medical device has ended
Examples:
- A manufacturer/importer is once again able to meet the demand for a device in shortage.
- A manufacturer/importer is unable to meet the demand for a specified medical device and report the shortage. After, they discover they are able to meet the demand for a compatible substitute device.
An end-of-shortage report must be submitted by the manufacturer or importer within 2 business days from the day the manufacturer is again able to meet the demand for the medical device. Include this date in the report as the end date for the shortage (subsection 62.23(6)).
Scenario 9: The shortage of a medical device has been avoided
Example:
- A manufacturer/importer has reported an anticipated shortage to Health Canada. However, they find a compatible substitute device prior to the anticipated start date of the shortage.
A manufacturer/importer must report that a shortage has been avoided if they reported an anticipated shortage to us and have found a solution to avoid the shortage before the start date of an anticipated shortage.
The end-of-shortage report, including the rationale for why the shortage has been avoided, needs to be submitted within 2 business days of becoming aware of the change (subsection 62.23(5)).
Scenario 10: Reporting the discontinuation of the sale of a medical device listed on the List of Medical Devices-Notification of Shortages
A manufacturer must report they are discontinuing the sale of a specified medical device in Canada if the discontinuation may cause a shortage (subsection 62.23(2)).
The report needs to be submitted within 5 business days after the day of making the decision to discontinue sale in Canada (subsections 62.23(2)).
How to report
To report a shortage
To report a 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.
- Report a shortage
At a minimum, the following information is required when submitting a medical device shortage report, update report or final report to Health Canada:
- name and contact information for the manufacturer of Class I to IV devices and/or the importer of Class I devices
- medical device licence (MDL) number for Class II, III or IV devices
- 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, as it appears on the device label
- description of the medical device, its packaging and an indication of whether it is a single-use device
- date when the shortage began or is anticipated to begin (start date of shortage)
- date when the manufacturer anticipates meeting the demand for the medical device (estimated end date of shortage), if known
- description of the reason for the shortage
- description of the information that the manufacturer of a Class I to IV device or an importer of a Class I device relied upon to determine that a shortage exists or is likely to occur, such as:
- details on the reason for the manufacturing disruption of the affected medical device
- information on a compatible substitute device
- details on how long your Canadian inventory will last, given the current and anticipated demand
- details on the current Canadian demand for the medical device
- details on your total manufacturing capacity for the specified device and how many units of the device your company is shipping to Canada per week/month/year
- information (if known) on any compatible substitute devices manufactured by other companies
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. You must provide the information listed above for each additional device.
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. Include your Health Canada-issued shortage report number, if known.
To report an avoided shortage
The manufacturer of a Class I to IV device and an importer of a Class I device must report the shortage has been avoided if they:
- reported an anticipated shortage to us and
- are able to resolve or avoid the shortage before the date of their anticipated shortage
This report must be submitted to Health Canada within 2 business days of becoming aware of the change.
In these cases, complete the following form and indicate the rationale for why the shortage has been avoided under the "Rationale for why the shortage has ended" section:
To report the end of a shortage, complete the following form:
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 or
- a manufacturer reporting the shortage has an acceptable substitute option manufactured by them
To report a discontinuation:
- A form to report a discontinuation is in development and will be live on March 1, 2022
A manufacturer of Class I to IV devices or an importer of Class I devices must report a discontinuation of a specified medical device to Health Canada if:
- they decide to discontinue sale of the device in Canada and
- discontinuation is likely to result in a shortage
This does not affect the obligation of an MDL holder to report a discontinuation under section 43(3) of the Regulations. This section states that if the MDL holder discontinues the sale of the medical device in Canada, the licensee shall inform the Minister within 30 days after the device has been discontinued. The licence will be cancelled at the time that the Minister is informed.
If an actual or anticipated shortage of the reported discontinued medical device occurs before the reported discontinuation date, the manufacturer of a Class I to IV device and importer of a Class I device must report this as a shortage.
If you are not sure whether to notify us about a shortage or discontinuation of a particular device, email us at MD.shortages.Penurie.de.IM@hc-sc.gc.ca.
Compliance and enforcement
Health Canada undertakes compliance and enforcement activities in accordance with the Compliance and enforcement policy for health products (POL-0001). This policy describes our national compliance and enforcement approach for all health products regulated under the Food and Drugs Act and its Regulations. Compliance and enforcement actions are based on the risk posed to the health and safety of people living in Canada and the seriousness of the non-compliance.
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