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 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, located on Health Canada’s website, 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 firstname.lastname@example.org.
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 Health Canada receives a medical device shortage report, we 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
If no acceptable substitute options are available for sale in Canada, information about the 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
Reporting and posting information about medical device shortages provides information to Canadians to help minimize the impact on patient care.
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