Amendments to the Medical Devices Regulations to address future public health emergencies: Notice

Date published: January 3, 2024

Background

On February 22, 2023, the Regulations Amending the Medical Devices Regulations (Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19) came into force. We introduced these amendments in Part 1.1 of the Medical Devices Regulations (MDR). The amendments were made to create a permanent regulatory framework to allow faster access to COVID-19 medical devices for which there is an urgent public health need.

On January 3, 2024, the Regulations Amending the Medical Devices Regulations (Medical Devices for an Urgent Public Health Need) (regulations) came into force. These regulations broaden the scope of Part 1.1 to apply to future public health emergencies for which there is an urgent public health need, when necessary.

About the amendments

Health Canada is maintaining all Part 1.1 requirements and exemptions, unless otherwise specified.

To support the regulations, we have published the following guidance document:

Medical devices for an urgent public health need

This guidance document explains how to apply for an authorization to import and sell medical devices for an urgent public health need.

As a result of these amendments, we also amended the Fees in Respect of Drugs and Medical Devices Order (fees order) to reflect the broadened pathway under the MDR.

The amended fees order took effect on the same day as the amended regulations.

For more information on the applicable fees, consult the following guidance document:

Fees for the review of medical device licence and authorization amendment applications

Changes related to all medical device manufacturers

These changes apply to all medical device manufacturers that:

currently have an authorization under Part 1.1
have submitted an application for authorization or amendment under Part 1,1 or
are considering submitting an application

List of medical devices for an urgent public health need

To reflect the broadened scope of Part 1.1, the Minister can now add medical conditions to the List of medical devices for an urgent public health need (UPHN list). The Minister can do so only if they have reasonable grounds to believe that:

the medical condition presents, or is the result of, a significant risk to public health in Canada and
immediate action is required to deal with the risk

The Minister can also add a medical device or a category of devices to the UPHN list. They can do so only if they have reasonable grounds to believe there is an urgent public health need related to a corresponding medical condition on the list.

List of medical devices for expanded use

Similar to the UPHN list, the Minister can add medical conditions to the List of medical devices for expanded use (expanded use list). The Minister can issue expanded use indications for Class II to IV authorizations under Part 1.1 or devices licensed under Part 1. The Minister can do so only if they have reasonable grounds to believe there is an urgent public health need for the expanded use of the device related to a corresponding medical condition.

Applications in queue

Previously, under Part 1.1, medical devices had to be on the UPHN list when:

a manufacturer submitted their application and
the Minister made the decision to issue an authorization

Now, Health Canada is able to review and issue an authorization to a manufacturer as long as the medical device:

was on the UPHN list when the manufacturer submitted their application and
the application met all issuance criteria

With this amendment, manufacturers can be confident that their application will continue to be assessed. This is the case even if the device is removed from the UPHN list after the application is submitted but before a decision is issued on their application.

Refusal authority

Previously, the Minister refused to amend an authorization if information in the application indicated the manufacturer would change the purpose of the medical device to make it unrelated to COVID-19.

To reflect the broadened regulations, the Minister may now refuse to amend an authorization if the manufacturer of a medical device would change its purpose to not be related to:

any medical conditions for which the device was first authorized or
any medical conditions that were on the UPHN list for the device and have been added to the authorization previously through an amendment or
any medical conditions that are on the UPHN list at the time the amendment application is submitted

An authorization holder will be able to amend their authorization to be in relation to a medical condition other than the one it was initially authorized for.

Changes related to Class I medical device manufacturers

These changes apply to all Class I medical device manufacturers who currently hold an authorization under Part 1.1 of the MDR.

Application to amend a Class I authorization

Previously, the holder of an authorization of a Class I device only had to submit an amendment application if a change was going to be made to the:

class of the device or
name of the manufacturer or device or
identifier of the device

Now, the holder of an authorization of a Class I device must also submit an amendment application if they intend to change the medical conditions, purposes or uses of the device.

This new requirement is in line with the expectations for Class II to IV medical devices. Authorization holders of these devices must not amend their authorization to indicate the device would not be manufactured, sold or represented for use related to a corresponding medical condition on the UPHN list.

Prohibition on Class I advertising

The authorization holder will not be allowed to advertise a Class I medical device if:

the device is subject to a change that requires an amendment and
the amended authorization has not been granted to the authorization holder

This prohibition is in line with the existing advertising prohibition for Class II, III and IV devices in the MDR.

Updated post-market reporting requirements

These changes are minor updates to the post-market reporting requirements.

Manufacturer's obligation to inform the Minister

Under Part 1.1, an authorization may be issued based on an authorization issued by a regulatory agency on the List of Regulatory Agencies for the Purposes of Subsection 68.11(4) of the Medical Devices Regulations (regulatory agencies list).

If an authorization is issued on the basis of subsection 68.11(4), the authorization holder must now notify the Minister if the authorization or licence for sale issued by the regulatory agency is suspended or revoked. The authorization holder must inform the Minister within 72 hours after receiving notice or becoming aware of the suspension or revocation. This is in line with obligations under Part 1 of the MDR.

After the Minister is informed, the Minister may cancel the authorization.

Foreign risk notification reporting for importers

If a Class II to IV medical device is removed from the UPHN list, importers of these devices authorized under Part 1.1 must submit to the Minister information about any serious risk of injury to human health. The regulations now make this obligation clear.

This requirement is in line with the post-market reporting requirement for importers in Part 1 of the MDR.

Contact us

For more information, please contact our Medical Devices Directorate at meddevices-instrumentsmed@hc-sc.gc.ca.

For questions about your particular authorization or application or about new applications, please email us at devicelicensing-homologationinstruments@hc-sc.gc.ca.

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2024-01-03

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