Medical device shortages: Overview
On this page
- 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
What is a medical device shortage
On March 30, 2020, the Minister of Health approved the Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in relation to COVID-19. This Interim Order is needed because of the unprecedented demand and urgent need for medical devices to treat, diagnose and protect Canadians during COVID-19.
An Interim Order is one of the fastest mechanisms available to address large-scale public health emergencies.
This Interim Order requires manufacturers and importers to:
- report shortages of medical devices that are on the list of medical devices – notification of shortages related to COVID-19
A medical device shortage occurs when a manufacturer is unable to meet Canadian market demand for the device or for its components, accessories, parts or consumable materials. It does not include a situation in which a substitute device, component, accessory, or part is available.
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
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, via email to email@example.com.
Manufacturers are also encouraged to report shortages for medical devices not listed on the list of medical devices – notification of shortages. Health Canada encourages voluntary reporting from manufacturers 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, consumable material 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 in relation to COVID-19 must be reported to Health Canada when:
- a manufacturer first becomes aware of shortage (within 5 calendar days)
- updated information needs to be submitted (within 2 calendar days)
- the end of the shortage needs to be reported (within 2 calendar 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. We also confirm that there is no other acceptable substitute option available in Canada.
An acceptable substitute option is:
- a Class I device that’s authorized for sale or import by a Medical Device Establishment Licence (MDEL) holder
- a Class II to IV device that’s licensed by Health Canada
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 manufacturers of an identified substitute device to determine if it is 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:
- they have an acceptable substitute that can be readily substituted for the device in shortage is available and
- the substitute device is also not in shortage
If the report meets the definition of a shortage and no acceptable substitute options are 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
Reporting and posting information about medical device shortages provides information to Canadians to 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.
For more information on reporting medical device shortages, please consult the COVID-19 guidance for reporting medical device shortages (GUI-0137).
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