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Report a medical device shortage

Manufacturers of Class I to IV medical devices and importers of Class I medical devices must report medical device shortages for devices that are on the List of Medical Devices – Notification of Shortages by completing the form below.

Privacy notice statement

Personal information is collected under the authority of the Food and Drugs Act and the Privacy Act for the purpose of delivering the mandatory shortage reporting program for medical devices under the Health Canada mandate.

Your personal information when disclosed to the Health Canada is confidential and protected. This information is administered and retained in accordance with the Food and Drugs Act and is protected as personal information under the Privacy Act, and in the case of an access to information request, under the Access to Information Act. Your personal information is stored and maintained in an appropriate database and / or filed in accordance with the department's best practices.

Please note that for shortages posted on the Medical device shortages: List of shortages website, the company name of the importer who reports the medical devices shortages will be published in the table with the manufacturer's name for specified medical device(s) on Health Canada's website.

You have the right to access your personal information and request changes if the information is incorrect. Questions or comments regarding the administration of the Privacy Act in our Department may be directed to the Health Canada's Access to Information and Privacy Coordinator. For additional information on privacy issues and the Privacy Act in general, consult the Office of the Privacy Commissioner of Canada or call 1 800-282-1376 or 819-994-5444.

Shortage information

Type of report(s)Footnote 2
Status of report(s)
Type of shortage(s)
Scope of shortage(s)
Description of the device: Single-use product (required)
Class of medical device (I, II, III or IV), if known


Note: Please indicate N/A for Class I devices or for devices that have authorization identification number(s)

Note: Please indicate N/A for Class II, III and IV devices that have medical device licence number(s) or for Class I devices without authorization identification number(s)





Pick a date from a calendar for field: Anticipated or actual start date of shortage

Pick a date from a calendar for field: Estimated end date of shortage
Confirmation (required)

Manufacturer's mailing address






Reporter contact information

Type of reporter






Please include country code, if outside North America. Note: Do not use brackets.


Footnotes

Footnote 1

A shortage report number will be provided when Health Canada follows up on an initial shortage report. This field only needs to be completed when an 'Update' report is submitted.

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Footnote 2

Select 'Mandatory' if you are a Class I to IV manufacturer, Class I importer or a designated importer, and the device in shortage is found on the List of medical devices.

Select 'Voluntary' if 'Mandatory' does not apply.
Select 'Unknown' if you are unsure.

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Footnote 3

Recommend providing the name as it appears on the label, if available. The medical device, component, accessory or part name may or may not be the same as the device name or licence name.

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Footnote 4

Recommend providing the device identifier (for example, serial number, catalogue number, part number, model number, unique device identifier) as it appears on the label, if available. If necessary, please consult the Medical Devices Active Licence Listing (MDALL), a reference tool for licensed medical devices in Canada. You may also consult other listing tables for devices authorized by Health Canada for exceptional importation and sale under sections 62.27 to 62.32 of the Medical Devices Regulations, including the:

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Footnote 5

Provide information 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

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Footnote 6

This information may be posted online. Examples of information to include:

  • description of alternative devices
  • 1-800 support numbers
  • website for additional information

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