Medical device shortages: Overview
On March 2, 2022, new amendments to the Medical Devices Regulations will come into force. The amendments will make permanent mandatory reporting of medical device shortages for devices on the List of specified medical devices. To support these amendments, we have drafted an amended draft guidance document. We are accepting comments or questions on this document until January 7, 2022.
On this page
- Regulatory updates
- What is a medical device shortage
- Who needs to report a medical device shortage
- When does a medical device shortage need to be reported
- What happens when a medical device shortage is reported
On March 2, 2022, new amendments to the Medical Devices Regulations will come into force. These amendments will make permanent mandatory reporting of medical device shortages and add a new requirement for reporting discontinuations for devices on the List of specified medical devices. They have been published in Canada Gazette, Part II.
Health Canada is posting amended draft guidance related to medical device shortages to support the new amendments. The advance publication will help manufacturers, importers and distributors become familiar with any changes before they come into force. You may:
- send your comments or questions on the amended draft guidance to MD.shortages.Penurie.de.IM@hc-sc.gc.ca
- indicate "draft guidance comments" in the subject line
- please submit all questions and comments before January 7, 2022
The final guidance document will be available on March 2, 2022, along with a medical devices compliance program (MDCP) bulletin.
Until March 2, 2022, shortage reporting requirements under the Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 remain in effect. Also in effect is the current COVID-19 guidance for reporting medical device shortages (GUI-0137).
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:
- actual, when the current supply can't meet current demand
- anticipated, when the future supply can't meet projected demand
Who needs to report a medical device shortage
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 MD.shortages.Penurie.de.IM@hc-sc.gc.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:
- 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
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 the List of medical devices-Notification of shortages must be reported to Health Canada when:
- a manufacturer or importer first becomes aware of shortage (within 5 business days)
- updated information needs to be submitted (within 2 business days)
- the end of the shortage needs to be reported (within 2 business days)
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:
- whether the report meets the definition of a shortage
- whether the manufacturer who has the shortage has an acceptable substitute option available in Canada
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 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:
- the manufacturer has an acceptable substitute that can be readily substituted for the device in shortage available and
- the substitute device is also not in shortage
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:
- 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 uses this information:
- for the case management of a shortage
- to work with industry to identify mitigation strategies and
- to help inform the procurement of medical devices for Canada
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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