Guide to reporting medical device shortages and discontinuations: Definitions and instructions

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• Definitions
• Instructions

Definitions

Medical device: a device within the meaning of the Food and Drugs Act, but does not include any device intended for use in relation to animals

List of Medical Devices - Notification of Shortages: the List of Medical Devices – Notification of Shortages that is published by the Government of Canada on its website, as amended from time to time

Specified medical device: a medical device that belongs to a category of medical devices that is set out in the List of Medical Devices - Notification of Shortages

Shortage: for a medical device, a situation in which the manufacturer of the device is unable to meet the demand for the device in Canada

Actual shortage: a manufacturer's current supply cannot meet current demand in Canada

Anticipated shortage: a manufacturer's future supply cannot meet projected demand in Canada

Avoided shortage: an anticipated shortage that will no longer occur

Resolved shortage: an actual shortage where:

• a manufacturer has found an acceptable substitute option
• 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

Authorization identification number: number assigned to devices authorized for importation or sale under an interim order made under section 30.1 of the Food and Drugs Act

Discontinuation of a medical device: a manufacturer decides to discontinue the sale of a specified medical device in Canada and the discontinuation will lead to a shortage

Health care professional: a person who is entitled under the laws of a province or territory to provide health services in the province or territory

Manufacturer: a person who:

• sells a medical device under their own name, or under a trademark, design, trade name or other name or mark owned or controlled by the person and
• is responsible for designing, manufacturing, assembling, processing, labelling, packaging, refurbishing or modifying the device, or for assigning to it a purpose, whether those tasks are performed by that person or on their behalf

Importer: a person in Canada, other than the manufacturer of a device, who is responsible for bringing the medical device into Canada for sale

Distributor: a person:

• other than a manufacturer, an importer or a retailer who sells a medical device in Canada for the purpose of resale or use, other than for personal use
• outside of Canada who sells medical devices into Canada

Instructions

Below are instructions on completing the medical device shortage reporting form.

Shortage report number(s): 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.

Name of medical device: Provide the name as it appears on the device 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.

Device identifier(s): Provide the device identifier (for example, serial number, catalogue number, part number, model number, unique device identifier) as it appears on the device 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 importation or sale under an interim order made under section 30.1 of the Food and Drugs Act, including the:

• List of authorized medical devices other than testing devices
• List of medical devices for exceptional importation and sale

Reason for shortage: Common reasons for why a shortage can occur and are part of the drop-down menu in the 'Electronic reporting form – Reason for shortage' section include:

• Disruptions in manufacturing: the circumstances that impede the actual manufacturing of a device, such as:
  • change in ownership
  • equipment breakdown
  • inability to source components or parts
  • natural disasters and pandemics
  • insufficient employees available
• Device was subject to recall: the action taken by the manufacturer, importer or distributor of the device to:
  • recall or correct the device or
  • notify its owners and users of its defectiveness or potential defectiveness
• Delay in shipping of a medical device: a situation in which a shortage results from the delays in getting a device shipped, such as:
  • increased shipping volumes
  • shortage of shipping containers
  • blocked transportation routes (for example, rail lines)
  • strikes (for example, major shipping company)
• Increase in demand for the medical device: the inability of a manufacturer to produce a sufficient quantity of devices to fulfill their customer orders
• Licensing issue: the suspension or cancellation of an existing medical device licence (MDL) or medical device establishment licence (MDEL) due to a:
  • compliance issue
  • licence that has not been renewed during the annual renewal process or
  • MDL requiring an amendment application
• Export restrictions: restrictions imposed by foreign governments that limit the number of devices allowed for export to other countries
• Discontinuation: a manufacturer decides to discontinue the sale of a medical device in Canada

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

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