Medical device shortages: Overview

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What is a medical device shortage

On March 1, 2021, the Minister of Health approved Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19. Interim Order No. 2 repeals and replaces Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in relation to COVID-19 made by the Minister on March 30, 2020.

Interim Order No. 2 is needed because of the unprecedented demand and urgent need for medical devices to treat, diagnose and protect Canadians during the pandemic. An interim order is one of the fastest mechanisms available to address large-scale public health emergencies.

Interim Order No. 2 requires manufacturers and importers to report shortages of medical devices that are on the list of medical devices: notification of shortages.

It also requires manufacturers, importers and distributors to provide additional information related to a shortage when requested by Health Canada in an acceptable or specified electronic format within a specified time limit.

Medical device shortages that were reported under the previous Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 do not need to be reported again.

A medical device shortage occurs when a manufacturer of a medical device is unable to meet Canadian market demand for the device or for its components, accessories or parts. It does not include a situation in which the manufacturer is also the manufacturer of a substitute device, component, accessory or part and is able to meet demand for it in Canada.

There are 2 types of shortages:

  1. actual, when the current supply can't meet current demand
  2. anticipated, when the future supply can't meet projected demand

Who needs to report a medical device shortage

Manufacturers and importers must report shortages that are on the list of medical devices: notification of shortages by completing the electronic reporting form.

To avoid duplicate reporting, a manufacturer may permit a designated importer of a medical device to prepare and submit a shortage report on its behalf. This is permitted only when the information that would have been reported to Health Canada by the manufacturer and importer is identical. Under these circumstances, the manufacturer must submit an authorization form to Health Canada by email to hc.meddev-matmed.sc@canada.ca.

Manufacturers, importers and other stakeholders are also encouraged to report shortages for medical devices not on the list of medical devices: notification of shortages. Health Canada encourages voluntary reporting for a medical device shortage when it meets the following criteria:

Voluntary shortage reports can also be submitted using our electronic reporting form.

When does a medical device shortage need to be reported

Information about a medical device shortage for a device that is on list of medical devices: notification of shortages must be reported to Health Canada when:

A medical device shortage does not need to be reported to Health Canada if the manufacturer or importer is able to fulfill customer orders within 30 days after the day they anticipate or become aware of the shortage. An example is if the device is back-ordered. A back-order becomes a shortage and must be reported to Health Canada if it cannot be resolved within 30 days.

What happens when a medical device shortage is reported

Once we receive a medical device shortage report, we follow up with the manufacturer to ask additional questions about the company's supply and demand to confirm:

An acceptable substitute option is:

A manufacturer or importer must submit a shortage report for medical devices listed on the list of medical devices: notification of shortages even if another manufacturer's substitute device exists on the market. We follow up with other manufacturers of identified substitute devices to determine if they're available in Canada.

A shortage report does not need to be submitted if the manufacturer or importer who is responsible for reporting a shortage can confirm:

If the report meets the definition of a shortage and the reporting manufacturer does not have an acceptable substitute option available for sale in Canada, information about the shortage is posted online to:

Health Canada uses this information:

Information received from voluntary shortage reports also helps us identify new or emerging shortages of medical devices.

Under Interim Order No. 2, the Minister of Health may compel a manufacturer, importer or distributor who imports or sells a medical device to provide information within their control about a shortage or potential shortage of the device under certain conditions.

For more information on reporting medical device shortages, please consult the Report COVID-19 guidance for reporting medical device shortages (GUI-0137).

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