Draft guidance for reporting medical device shortages: What must be reported

On this page

• About mandatory reporting of medical device shortages
• Minister's power to require information about a shortage
• Mandatory reporting of medical device shortages
• A shortage (back-order) of more than 30 days
• When medical device shortages do not need to be reported

About mandatory reporting of medical device shortages

Section 1 of the Regulations is amended to define a medical device shortage as a situation in which a manufacturer of a medical device is unable to meet the demand for a device in Canada.

Health Canada interprets the definition of 'shortage' for medical devices to include 2 types of shortages:

1. actual shortages, where the current supply can't meet current demand
2. anticipated shortages, where the future supply can't meet projected demand

Under section 62.22 of the Regulations, Health Canada may add categories of medical devices to the List of medical devices - Notification of shortages. We may consider adding a category of medical devices to the list only if we have reasonable grounds to believe that a shortage presents or may present a risk of injury to human health. A device that belongs to a category of devices that is on this list is called a "specified medical device".

Under sections 62.23 to 62.25 of the Regulations, manufacturers of Class I to IV devices and importers of Class I devices are required to:

• report actual or anticipated shortages of a specified medical device
• update the status of a reported shortage if there is a change in the shortage information submitted
• report the end of a shortage
• report the discontinuation of a specified medical device sold in Canada if that discontinuation will lead to a shortage

A manufacturer does not need to report a shortage if they can meet the demand with a substitute device that they manufacture (including its components, accessories or parts).

For example, a manufacturer may be experiencing a shortage in accessories for laryngoscopes or ventilators. They are not required to report the shortage if they manufacture a compatible substitute device that is:

• fully interchangeable for the device in shortage
• authorized for sale in Canada and
• meets the Canadian market demand

When deciding on a substitute device, the manufacturer of Class I to IV medical devices and the importer of Class I medical devices should consider the following:

• whether the substitute device, component, accessory or part is fully interchangeable with the specified device in shortage
• additional concerns regarding the use of a substitute device, such as:
  • does the substitute device have the same intended use
  • does the performance, safety or effectiveness of the device introduce new risks to the patient
• the ability for the substitute device to meet Canadian market demand for the device

Devices that are on back-order for less than 30 calendar days also do not need be reported to Health Canada as shortages.

Minister's power to require information about a shortage

Under section 62.26 of the Regulations, the Minister of Health may request manufacturers, importers or distributors of medical devices to provide information about a shortage. This authority will help assess the level of risk posed by a shortage or potential shortage of the medical device. The information may be requested if the Minister has reasonable grounds to believe that:

• there's a shortage of the device in Canada or the device is at risk of going into shortage
• a shortage of the device presents or may present a risk of injury to human health
• the information is necessary to establish or assess:
  • the existence of a shortage or risk of shortage
  • the reasons for a shortage or risk of shortage
  • the effects or potential effects on human health of a shortage, or
  • measures that could be taken to prevent or alleviate a shortage; and
• the manufacturer, importer or distributor will not provide the information without a legal obligation to do so

The Minister can't require a person to create new information, such as conducting new analysis or studies.

The request can only be made of the person holding the information.

When responding to a mandatory information request, manufacturers, importers and distributors must provide additional information about a shortage that is specified by the Minister. The information must be submitted electronically by the deadline. The request will contain instructions for submitting the information, including the format for submitting that information.

Mandatory reporting of medical device shortages

Only shortages of devices (including components, accessories and parts) that belong to a category specified on the List of medical devices - Notification of shortages must be reported (section 62.21 of the Regulations). The list changes as medical devices are added or removed based on shortage status, availability of substitute devices and risk and scope of potential shortages.

Health Canada gathers information about emerging and potential shortages from industry, other governments, health care institutions and professionals, international regulators and other stakeholders. We use this information and other data to decide which medical devices are to be added or removed from the list.

Using an established process for adding a category of device to the List of medical devices - Notification of shortages, we consider several factors to determine if a shortage or potential shortage of a device may present a risk of injury to human health.

Once we decide to add or remove a device from the list, we notify manufacturers and importers via a Medical Device Compliance Program Bulletin. We also reach out to those manufacturers and importers that are directly impacted. We also encourage manufacturers and importers to review the list regularly.

To comply with mandatory reporting under section 62.23, manufacturers of Class I to IV devices and importers of Class I devices must file the following reports within these 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)
• a medical device discontinuation report within 5 business days after the day of making the decision to discontinue sale in Canada

For instructions on how to report, refer to the section on when and how to report.

Exemptions

Manufacturers and importers do not need to report a medical device shortage to Health Canada if they anticipate 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 is outlined in subsection 62.23(7) of the Regulations. This includes devices that are on back-order for less than 30 calendar days.

As well, a manufacturer of a Class I to IV device or importer of a Class I device does not need to report a medical device shortage if they:

• are also a manufacturer of another medical device that can be substituted for the device in shortage and
• are able to meet the demand for this substitute device

This is outlined in subsection 62.23(9) of the Regulations.

An acceptable substitute option must be authorized for sale in Canada.

A shortage (back-order) of more than 30 days

Manufacturers of Class I to IV devices and importers of Class I devices may anticipate they can meet the demand for a device pursuant to subsection 62.23(7). They may then conclude later that they cannot meet the demand within a 30-day calendar period. In this case, they must report a medical device shortage.

This is outlined in subsection 62.23(8) of the Regulations. For example, a back-order becomes a shortage and must be reported if it cannot be resolved within 30 calendar days. A manufacturer and importer must report such a shortage within 5 business days from when they learn that it will exceed 30 calendar days.

When medical device shortages do not need to be reported

A manufacturer or importer does not need to report a medical device shortage under a number of situations. These situations include:

• a manufacturer or importer who had previously reported a shortage under one of the interim orders
  • Interim order respecting drugs, medical devices and foods for a special dietary purpose in relation to COVID-19
  • Second interim order respecting drugs, medical devices and foods for a special dietary purpose in relation to COVID-19
• an actual or an anticipated shortage of a Class I medical device that is not authorized for sale or import in Canada by an MDEL holder
• an actual or an anticipated shortage of a Class II, III and IV medical device that is not licensed for sale in Canada
• an actual or an anticipated shortage of a medical device that has not entered the Canadian market (not yet sold in Canada)
• a manufacturer or importer who has never sold or imported medical devices in Canada and is having problems obtaining supply (a new supplier)
• a manufacturer or importer who has previously sold medical devices is not actively selling in Canada and does not have any orders in Canada
• disruptions in manufacturing that don't cause a shortage

Documented procedures for mandatory shortage reporting

Health Canada recommends that manufacturers and importers develop a process for reporting medical device shortages to us as part of their internal quality management system. When developing internal written procedures for reporting medical device shortages, we suggest that manufacturers and importers consider:

• Health Canada shortage reporting requirements
• which department is responsible for reporting shortages to us
• timeline requirements for initial shortage reports, updates, avoided shortages, shortage closures and device discontinuation
• a procedure for checking the List of medical devices - Notification of shortages regularly to ensure you are reporting all mandatory medical device shortages
• subscribing to our Medical Device Compliance Program Bulletin to ensure your company is up to date on the latest developments on shortage reporting
• risk mitigation steps to be taken to address medical device shortages in your organization