Draft guidance for reporting medical device shortages: Definitions and instructions

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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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:

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

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:

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:

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. Examples include:

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:

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

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