Draft guidance for reporting medical device shortages: Background

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

Date published: November 30, 2021

Disclaimer

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 1, 2022. These sections:

A specified medical device is:

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 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 Health 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 are required to report a shortage of the device to Health Canada. Manufacturers may also voluntarily report shortages of other devices to support the department's work on shortage monitoring.

Distributors

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).

Provincial/territorial governments

To prevent and/or reduce the impact of medical device shortages, provincial and territorial governments may:

Group purchasing organizations

Group purchasing organizations also have an important role to play in preventing and mitigating medical device shortages. They may:

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:

International partners

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

Health Canada administers the Food and Drugs Act, Radiation Emitting Devices Act and Medical Devices Regulations, including provisions for mandatory reporting of medical device shortages coming into effect on March 1, 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.

When it comes to medical device shortages, 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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