Medical device shortages: Overview

On this page

• Introduction
• What is a medical device shortage
• What is a medical device discontinuation
• Who needs to report a medical device shortage
• Who needs to report a medical device discontinuation
• Voluntary reporting of medical device shortages and discontinuations
• When to report a medical device shortage
• When to report a medical device discontinuation
• What happens when a medical device shortage is reported
• What happens when a medical device discontinuation is reported

Introduction

On March 2, 2022, new amendments to the Medical Devices Regulations came into force.

With these amendments, manufacturers and importers must report shortages and discontinuations that may lead to a shortage of medical devices that are on the List of Medical Devices - Notification of Shortages.

As well, 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 a device, under certain conditions. The information is to be provided in an acceptable or specified electronic format within a specified time limit.

To support medical device shortage and discontinuation reporting, Health Canada has posted guidance for reporting medical device shortages and discontinuations (GUI-0137).

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 and Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 do not need to be reported again.

What is a medical device shortage

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 that can be substituted for the device in shortage 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

What is a medical device discontinuation

In the context of shortages, a medical device discontinuation occurs when the manufacturer of a Class I to IV medical device decides to discontinue the sale of a specified medical device in Canada and it will lead to a shortage.

Who needs to report a medical device shortage

Manufacturers of Class I to IV medical devices and importers of Class l medical devices must report medical device shortages for devices on the List of Medical Devices - Notification of Shortages. They can submit shortage reports by completing the electronic reporting form.

Who needs to report a medical device discontinuation

Manufacturers and designated importers, who have been authorized to report on behalf of a manufacturer, must report medical device discontinuations that will lead to a shortage for devices on the List of Medical Devices - Notification of Shortages. They can submit a discontinuation report by completing the electronic reporting form.

Medical device licence (MDL) holders are still obligated to report a discontinuation under section 43(3) of the Medical Devices 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. To report a discontinuation under section 43(3), contact the Medical Devices Directorate at devicelicensing-homologationinstruments@hc-sc.gc.ca.

A manufacturer may permit a designated importer of a medical device to prepare and submit a shortage or discontinuation 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 MD.shortages.penurie.de.IM@hc-sc.gc.ca.

Voluntary reporting of medical device shortages and discontinuations

Manufacturers, importers and other stakeholders may also voluntarily report medical device shortages and discontinuations. A voluntary report is a report for medical devices not on the List of Medical Devices - Notification of Shortages. These voluntary reports help us identify new or emerging shortages, determine trends in the medical device supply chain and any areas of risk of concern for shortages.

Health Canada encourages voluntary reporting for a medical device shortage when it meets the following criteria:

• the shortage is likely to create a patient or user safety issue in Canada
• a substitute device, component, accessory, or part is not readily available in Canada
• the shortage is national in scope

Health Canada encourages voluntary reporting for a medical device discontinuation when it meets the following criteria:

• the discontinuation is likely to result in a shortage

Submit voluntary reports using our electronic shortages reporting form or discontinuation reporting form.

When to report a medical device shortage

Information about a medical device shortage for a device that is on the List of Medical Devices - Notification of Shortages must be reported to Health Canada when:

• a manufacturer or importer first becomes aware of a shortage (within 5 business days)
• there is updated shortage information (within 2 business days)
• the shortage has ended (within 2 business days)

Manufacturers of Class I-IV medical devices and importers of Class I medical devices do not need to report a medical device shortage to Health Canada if they:

• anticipate that they can meet the demand for the device (or its components, accessories or parts) within 30 calendar days after the day they anticipate or become aware of the shortage. This includes devices that are on back-order for less than 30 calendar days or
• are also a manufacturer of another medical device that can be readily substituted for the device in shortage and are able to meet the demand for this substitute device

An acceptable substitute option is:

• a Class I device that's sold or imported by an authorized medical device establishment licence (MDEL) holder
• a Class II to IV device that's licensed by Health Canada
• any device that's authorized for sale or import under another interim order made under section 30.1 of the Food and Drugs Act

A manufacturer or importer must submit a shortage report even if another manufacturer's substitute device exists on the market.

When to report a medical device discontinuation

Information about a medical device discontinuation for a device that is on List of Medical Devices - Notification of Shortages must be reported to Health Canada within:

• 5 business days after the day of making the decision to discontinue sale in Canada

Only discontinuations of devices that will lead to a shortage need to be reported.

What happens when a medical device shortage is reported

Once we receive a medical device shortage report, we review the information to ensure that it is complete and that the report meets the definition of a shortage. We may, if needed, follow up with the manufacturer or importer to ask additional questions about the company's supply and demand information, back-orders or substitute device options available in Canada.

If the report meets the definition of a shortage, the confirmed shortage will be posted online.

Information is posted online to:

• alert health care facilities and other manufacturers of supply gaps
• help health care providers and patients make timely and informed choices about their health
• help minimize the impact on patient care

What happens when a medical device discontinuation is reported

Once we receive a medical device discontinuation report, we may follow up with the manufacturer or importer to confirm details about the discontinuation or about the shortage situation resulting from the discontinuation.

Confirmed reports of discontinuations that will lead to a shortage will be posted online to:

• alert health care facilities and other manufacturers of supply gaps
• help health care providers and patients make timely and informed choices about their health
• help minimize the impact on patient care

Health Canada depends on early reporting of anticipated or actual shortages or discontinuations to help us identify national critical shortages. We work with stakeholders to ensure an adequate supply of medical devices in Canada for national critical shortages. We may use regulatory or communication tools, and play a coordination role in managing these high-risk shortages.