COVID-19 guidance for reporting medical device shortages: What must be reported
Health Canada has made the medical device shortage reporting framework permanent by transitioning interim order provisions to the regulations. The interim order expired on March 1, 2022, at which time the new shortage reporting framework took effect. For more information, visit the Regulations amending certain regulations concerning drugs and medical devices (shortages): Notice
For mandatory reporting under sections 15(2) to 15(4) of Interim Order No. 2, manufacturers and importers must file the following reports within the specified timelines:
- an initial shortage report within 5 business days after the day on which they become aware of an actual or anticipated shortage
- an updated shortage report with any new information within 2 business days after the day on which they become aware of a change to any of the information already submitted, such as:
- the end date of the actual shortage
- if an anticipated shortage was avoided
- an end of shortage report within 2 business days after the day on which the manufacturer is able to meet the demand for the medical device (or for its components, accessories or parts)
Manufacturers and importers do not need to report a medical device shortage to Health Canada if the manufacturer anticipates to meet the demand for the device or for its components, accessories or parts within 30 days after the day they anticipate or become aware of the shortage. (See section 15(5) of Interim Order No. 2.) This includes devices that are on back-order for less than 30 days.
Manufacturers and importers must report a medical device shortage if they determine they are unable to meet the demand for the device within a 30-day period. (See section 15(6).) For example, a back-order becomes a shortage and must be reported to Health Canada if it cannot be resolved within 30 days. A shortage report must be reported within 5 business days from when the manufacturer or importer become aware that a shortage or back-order situation will exceed 30 days.
Situations in which medical device shortages do not need to be reported include:
- an actual or an anticipated shortage for Class II, III and IV medical devices that are not licensed for sale in Canada
- an actual or an anticipated shortage for Class I medical devices that are not authorized for sale or import by a Medical Device Establishment Licence (MDEL) holder
- an actual or an anticipated shortage for medical devices that are not currently being sold in Canada
- a manufacturer or importer has a device in back-order that is not expected to go beyond 30 days
- a manufacturer is also the manufacturer of a substitute medical device and is able to meet demand for it in Canada
- a manufacturer or importer has never sold or imported medical devices in Canada and is having problems obtaining supply
- a manufacturer or importer is not actively selling in Canada and doesn't have any orders in Canada
- disruptions in manufacturing that are leading to a "longer lead time" but the disruptions do not result in a shortage
- "longer lead time" is the prolonged typical turnaround time it takes a manufacturer to deliver a device to a customer
- a medical device has been discontinued
- the manufacturer has stopped selling the device in Canada
Manufacturers, importers and other stakeholders are also encouraged to voluntarily report shortages of medical devices not included on the list of specified medical devices when:
- the shortage may cause a patient or user safety issue in Canada
- a compatible substitute medical device, component, accessory or part isn't available in Canada or can't be easily replaced
- for example, due to capital equipment costs, regulatory requirements to validate procedures, lack of compatibility of surgical instruments or with other devices, extensive training
This information helps us determine whether we should add a certain medical device to the list of specified medical devices for mandatory reporting.
If you are not sure whether to report a shortage of a device, please contact the Medical Devices and Clinical Compliance Directorate at MD.shortages-penurie.de.IM@canada.ca.
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