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

Date published: March 23, 2023

Health Canada is proposing regulatory amendments to the Medical Devices Regulations (MDR). We're proposing to expand the current provisions under Part 1.1 of the MDR, currently limited to COVID-19 medical devices, to apply to any future public health emergency. The proposed amendments will also result in administrative changes to the Fees in Respect of Drugs and Medical Devices Order (Fees Order).

Overview

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. These regulatory amendments resulted in the creation of Part 1.1 of the MDR.

Part 1.1 is a permanent regulatory framework for COVID-19 medical devices. It maintains many of the flexibilities provided under Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 (IO No. 3). This framework continues to enable accelerated access to COVID-19 medical devices for which there is an urgent public health need (UPHN) in Canada without relying on temporary regulatory measures.

Health Canada is proposing to expand the scope of Part 1.1 to:

apply to other medical conditions that present, or are the result of, a significant risk to public health in Canada, and immediate action is required to deal with the risk
include medical devices for which there is a UPHN to diagnose, treat, mitigate or prevent these medical conditions

The proposed amendments will also result in administrative changes to the Fees Order.

Based on experience from the COVID-19 pandemic, the proposed regulatory amendments would facilitate access for people in Canada to UPHN medical devices during a public health emergency.

Proposed regulatory amendments to the MDR

Health Canada proposes to maintain all Part 1.1 requirements and exemptions, unless otherwise specified in the following items.

Expand Part 1.1 to apply more than one medical condition

Health Canada is proposing to expand Part 1.1 to medical devices that have a UPHN in relation to a medical condition for which there is a public health emergency. All references to COVID-19 will be removed.

Expanding Part 1.1 is intended to be used in emergency situations where no other existing solution exists. It's not intended to be used as an alternative to existing pathways, such as:

Special Access Program
medical devices for exceptional importation and sale

Expand the provisions of the UPHN list

The List of Medical Devices for an Urgent Public Health Need in Relation to COVID-19(UPHN list) is a list incorporated by reference (ambulatory list that is amended from time to time) for COVID-19 medical devices for which there is a UPHN. The Minister of Health has the authority to add a device or category of devices that have a UPHN in relation to COVID-19 to the UPHN list.

Under the proposed amendments, the Minister would also need the authority to add more than 1 medical condition to the UPHN list.

A medical condition may be added to the UPHN list if the Minister has 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

Expand the provisions of the expanded use list

The List of Medical Devices for Expanded Use in Relation to COVID-19 (expanded use list) is a list incorporated by reference for Class II, III or IV medical devices that have been granted an expanded use indication in relation to COVID-19.

The Minister may grant an expanded use indication for a Class II, III or IV medical device. With the expansion of Part 1.1, the expanded use list and any other relevant provisions would be amended to include additional medical conditions when necessary.

Ensure the Minister can continue to issue an authorization for a device in process

Currently, under Part 1.1, a device must be a:

UPHN medical device for a manufacturer to submit an application (subsection 68.11(1)) and
UPHN medical device for the Minister to issue an authorization (paragraph 68.12(b))

Between the time the manufacturer submits an application and the time the Minister decides to issue or refuse the application, the UPHN list may be amended. This could potentially change the UPHN status of a medical device while in review.

We're proposing regulatory amendments to avoid the automatic rejection of a device whose UPHN status changes while in the screening or review stage. Amendments such as removing provision 68.12(b) would give the Minister the ability to:

continue to review an application that is in progress and
issue an authorization even if the UPHN list changes before a decision is made

Require that authorization holders for Class I medical devices submit an application to amend their authorization when they intend to change the medical conditions, purposes or uses for which the device is manufactured, sold or represented

Under this measure, authorization holders of Class I devices would be able to submit an amendment if they intend to manufacture, sell or represent their device for another condition that is on the UPHN list. Thus, they will avoid having to submit another complete application to have the device authorized for the new condition.

Provide an explicit authority for the Minister to refuse to amend an authorization if the device is no longer related to a UPHN medical condition

Under section 68.17, the Minister must refuse to amend an authorization if information in the amendment application indicates the purpose of the medical device will be changed to make it unrelated to COVID-19. Since the scope of these regulations would be expanding, this would need to apply to other medical conditions.

We're proposing that the Minister must refuse to amend an authorization if the authorization holder of a Class I, II, III or IV device wants to change the purpose of the device to make it unrelated to:

the medical condition(s) it was first authorized for or
any medical condition(s) that would be on the UPHN list at the time the amendment application has been filed

The authorization holder can then decide to submit an application under Part 1 for a device that is not on the UPHN list.

If the authorization holder wants to remove the UPHN medical condition for which the device was initially authorized and add a new UPHN medical condition, they would need to apply for an amendment. The authorization holder would need to provide evidence to support the new condition for which they are seeking an authorization.

Require authorization holders to inform the Minister of a suspension or revocation

Currently under Part 1.1, the Minister may cancel an authorization that was issued based on an authorization or licence for sale by a foreign regulatory agency if:

the Minister becomes aware that the authorization or licence that had been issued by the regulatory agency is suspended or cancelled

We're proposing that the authorization holder will have to inform the Minister when an authorization or licence for sale of a device that was issued by a regulatory agency on the List of Regulatory Agencies for the Purposes of Subsection 68.11(4) of the Medical Devices Regulations is suspended or revoked if:

the authorization in Canada is based on the foreign authorization or licence

This would align with paragraph 61.2(2)(c) under Part 1 of the MDR. This paragraph requires manufacturers to submit to the Minister information on suspensions or revocations of authorizations or licences of any medical device that have taken place by a regulatory agency on the List of Regulatory Agencies for the Purposes of Sections 61.2 and 68.3 of the Medical Devices Regulations.

Fees

Authorization holders and applicants of devices that are on the UPHN list are exempt from paying fees as long as their medical device is on the UPHN list.

Health Canada proposes to maintain all Part 1.1 fee requirements and exemptions, unless otherwise specified in the following items.

Class I medical devices

Once a Class I medical device is removed from the UPHN list, to continue to sell or import the medical device, the manufacturer must comply with the additional requirements outlined in paragraph 68.21(1)(h). This includes paying all associated medical device establishment licence (MDEL) application fees.

If a Class I medical device is re-added to the UPHN list after the manufacturer started paying fees, the manufacturer must continue to pay the fees. This is because they had already begun paying fees and obtained an MDEL under Part 1 to continue to import or sell the medical device.

A manufacturer that does not want to pay fees because the device is now on the UPHN list would need to cancel their MDEL and apply for an authorization under Part 1.1. We would not reimburse any fees already paid.

Where the device is authorized for more than 1 UPHN medical condition, the authorization holder or applicant of that device would be exempt from paying the fees until the device is no longer related to a medical condition on the UPHN list.

Class II to IV medical devices

Once a Class II, III or IV medical device is removed from the UPHN list, to maintain their authorization, the manufacturer must comply with the applicable additional requirements. These are outlined in paragraphs 68.21(1)(i) to (j), and sections 68.3 and 68.31. This includes paying all associated fees.

If a medical device or category of medical device is added or re-added to the UPHN list after the manufacturer started paying fees, they would not have to pay fees from that point until the device is removed from the UPHN list. We would not reimburse paid fees or charge fees retroactively.

Compliance and enforcement

For medical devices authorized under this pathway, Health Canada would continue to follow the compliance and enforcement policy to:

promote and monitor compliance
undertake enforcement activities

Feedback and public comments

Health Canada is looking for feedback from stakeholders on this regulatory proposal.

In particular, we would like to know the following:

Based on what is described in this proposal, indicate whether you would use this pathway to seek authorization for your UPHN product in the Canadian market.
Indicate the factors that will contribute to your decision to seek authorization under Part 1.1 versus Part 1 of the MDR.
Indicate any concerns with expanding Part 1.1 to help address any future public health emergencies.

The consultation will be open for 21 days, ending April 13, 2023. After this date, we will review and consolidate responses. Your input will help us refine the proposal and develop related content.

Share your views: Consultation on proposed changes to the Medical Devices Regulations to address future public health emergencies

Contact us

You may submit your comments by emailing the Medical Devices Directorate at mddpolicy-politiquesdim.sc@hc-sc.gc.ca.

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Date modified:: 2023-03-23

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