Guide to reporting medical device shortages and discontinuations: Background
Date published: March 2, 2022
This document does not constitute part of the Food and Drugs Act (the Act) or its regulations. In the event of any inconsistency or conflict between the Act or regulations and this document, the Act or the regulations take precedence. This document is an administrative document that is intended to facilitate compliance by the regulated party with the Act, the regulations and the applicable administrative policies.
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About this guidance document
This guidance document supports amendments to section 1 and the introduction of sections 62.21 to 62.26 of the Medical Devices Regulations (Regulations), which go into effect on March 2, 2022. These sections:
- require manufacturers of Class I to IV medical devices and importers of Class I medical devices to report shortages of devices (including their components, accessories and parts) that are on the List of Medical Devices – Notification of Shortages
- require manufacturers or designated importers to report if the manufacturer is discontinuing the sale of a specified medical device in Canada and the discontinuation may cause a shortage
- permit the Minister of Health to require a manufacturer, importer or distributor to provide information requested about a medical device shortage
A specified medical device is part of a category of medical devices that is set out in the List of Medical Devices – Notification of Shortages.
The guidance is to help manufacturers, importers and distributors meet their regulatory obligations. It outlines in general language their responsibilities for the mandatory reporting of medical device shortages and discontinuations, and mandatory information requests as set out in the legislation.
This document also provides information on how to voluntarily report a shortage of a medical device that is not on the List of Medical Devices - Notification of Shortages. Although Canada’s role is focused on administering the requirements for mandatory shortage reporting, voluntary reports help us determine trends in the medical device supply chain and where there are areas of risk or concern.
Everyone has a role to play
Manufacturers and importers
Manufacturers and importers have a key role to play in preventing and reducing the impact of medical device shortages. They can control the volume of medical devices in the supply chain and can take steps to resolve a medical device shortage when one occurs. They are also in the best position to communicate to customers about the availability of their devices.
When a manufacturer experiences a shortage of a medical device it sells, we expect the manufacturer will take all necessary measures to resolve the shortage quickly. Manufacturers of specified medical devices must report a shortage of the device to Health Canada. We may require a manufacturer or importer to provide information about a shortage or potential shortage under certain conditions (refer to section 62.26 of the Regulations).
Manufacturers and importers may also voluntarily report shortages of other devices not on the List of Medical Devices - Notification of Shortages to support our work on shortage monitoring.
Distributors are not required to report shortages of specified medical devices. They are, however, an integral part of the medical device supply chain and may also help to prevent or mitigate medical device shortages. Health Canada may require a distributor to provide information about a shortage or potential shortage under certain conditions (refer to section 62.26 of the Regulations).
To prevent and/or reduce the impact of medical device shortages, provincial and territorial governments may:
- take measures to conserve their stock
- reallocate stock within regions or provinces/territories to where it is most needed and work together to share the existing supply
- identify and secure additional supplies of medical devices from other vendors or another provincial/territorial government
- identify and secure other compatible substitute medical devices
- voluntarily report shortages identified or anticipated at the provincial/territorial level to Health Canada to support our work on monitoring shortages
Group purchasing organizations
Group purchasing organizations also have an important role to play in preventing and mitigating medical device shortages. They may:
- engage stakeholders
- conduct market research
- ensure access to a diversity of suppliers
- negotiate with manufacturers on behalf of buyers
Health care authorities and health care professionals
Health care authorities and health care professionals also have an important role to play in preventing and mitigating medical device shortages. They may:
- conserve and reallocate stock in their area to meet their needs
- notify their applicable provincial or territorial departments about potential or actual shortages
- work with their procurement staff/organizations to secure substitute devices
- arrange suitable alternatives for patients
- voluntarily report shortages in a health care setting to Health Canada to support our work on monitoring shortages
Health Canada communicates with regulatory partners from around the world to share information on medical device shortages occurring in each other’s jurisdictions. Sharing information keeps us up to date on emerging shortages and the status of medical device shortages globally. It also keeps us up to date on efforts to mitigate shortages, such as identifying possible substitute devices available outside Canada.
Health Canada administers various legislations, including the Food and Drugs Act, Radiation Emitting Devices Act and Medical Devices Regulations. The provisions for reporting medical device shortages and discontinuations can be found in the Medical Devices Regulations, effective March 2, 2022.
Health Canada does not control the supply of medical devices in Canada or have the authority to compel a manufacturer to supply a device. We work with stakeholders across the medical device supply chain to help determine the details and status of a shortage. We also coordinate and facilitate proactive information sharing.
Health Canada depends on early reporting of anticipated or actual shortages to help us identify national critical shortages. We work with stakeholders to ensure an adequate supply of medical devices in Canada for national critical shortages. We may use regulatory or communication tools and play a coordination role in managing these high risk shortages.
The Minister of Health can compel manufacturers, importers or distributors who import or sell a medical device to provide information within their control about a device shortage or potential shortage under certain conditions. The ability to do so is outlined in section 62.26 of the Regulations.
Information collected by Health Canada will be subject to applicable laws, including the Privacy Act and Access to Information Act.
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