ARCHIVED Medical devices for use in relation to COVID-19: Overview

On January 3, 2024, Health Canada introduced the Regulations Amending the Medical Devices Regulations (Medical Devices for an Urgent Public Health Need). These regulations broaden the scope of Part 1.1 of the Medical Devices Regulations apply to other public health emergencies. For more information, please refer to the notice.

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Purpose

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. They are located in Part 1.1 of the Medical Devices Regulations (MDR). This document provides guidance on Part 1.1 (Regulations).

These Regulations introduced amendments to the MDR to create a permanent regulatory framework for COVID-19 medical devices. However, they continue to maintain 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). The Regulations continue 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.

The amended MDR provides predictability and stability to Health Canada as a regulator as well as to manufacturers, importers and distributors of COVID-19 medical devices.

The Regulations:

Scope and application

This document is for medical device manufacturers, importers, distributors and other stakeholders who import, sell or distribute medical devices manufactured, sold or represented for use in relation to COVID-19 in Canada.

This guidance explains how to apply to import or sell COVID-19 medical devices. Included are devices that are part of a system, test kit, medical device group, medical device family or medical device group family. These are defined in the MDR and further described in the guidance document on types of licence applications.

This guidance document will:

Policy objectives

This guidance document aims to:

Policy statements

To obtain an authorization to import or sell a COVID-19 medical device, manufacturers must submit an application to the Minister. This guidance outlines the information required to obtain an authorization to import and sell COVID-19 medical devices in Canada.

Part 1.1 of the MDR provides an expedited authorization pathway for:

Note: All active authorizations under IO No. 3 are authorizations for importation and sale under Part 1.1 of the MDR. Action is only required from the manufacturer if the device is not on the UPHN list at the time or to ensure compliance with the Regulations.

Outstanding applications submitted by manufacturers under IO No. 3 are active applications for authorization under these Regulations. These applications include amendments and applications for which Health Canada has yet to issue a decision. No immediate action is required from the manufacturer to transition to Part 1.1.

Part 1.1 also allows authorization holders to continue to benefit from the same flexibilities available under IO No. 3 for as long as their medical device is on the UPHN list. Examples of flexibilities include exemptions from requiring a medical device establishment licence, a specific quality management system certificate and paying fees.

Once a COVID-19 medical device is removed from the UPHN list or is not included on the UPHN list when the list first becomes available, Part 1.1 of the MDR allows:

Background

COVID-19 is an infectious disease caused by the coronavirus that emerged in 2019, SARS-CoV-2.

For more information on COVID-19, such as the current situation, symptoms, treatments and vaccines, refer to the coronavirus disease (COVID-19) page.

Since March 2020, the Government of Canada has introduced 3 consecutive medical device interim orders. These interim orders provide an expedited way to authorize the importation and sale in Canada of medical devices used to diagnose, treat, mitigate or prevent COVID-19. The Minister of Health introduced the following interim orders for medical devices:

Through these interim orders, Health Canada authorized:

Authorizations have been issued to both domestic and international manufacturers. These emergency measures have allowed people in Canada to have expedited access to necessary COVID-19 medical devices that are safe and effective.

Definitions

All expressions in this guidance document have the same meaning as under the MDR, unless indicated otherwise.

Authorization
An authorization that is issued under section 68.12.
Authorization holder
The manufacturer that was issued the authorization by the Minister.
COVID-19
The coronavirus disease 2019.
COVID-19 medical device
A medical device that is manufactured, sold or represented for use in relation to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Distributor
A person, other than a manufacturer, an importer or a retailer, who sells a medical device in Canada for the purpose of resale or use, other than for personal use. A person outside of Canada selling medical devices into Canada is also considered a distributor.
Harm
Physical injury or damage to the health of people (based on the definition in ISO 14971).
Importer
A person in Canada, other than the manufacturer of a device, who is responsible for the medical device being brought into Canada for sale.
Interim Order (IO) No. 3
Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19, which was made by the Minister on February 21, 2022, and published in the Canada Gazette, Part I, on March 12, 2022. This IO expired on February 21, 2023.
List of Medical Devices for an Urgent Public Health Need (UPHN list)
The List of Medical Devices for an Urgent Public Health Need in Relation to COVID-19 is published and maintained by the Government of Canada.
List of Medical Devices for Expanded Use (Expanded use list)
The List of Medical Devices for Expanded Use in Relation to COVID-19 is published and maintained by the Government of Canada.
Manufacturer

A person who:

  • sells a medical device under their own name, or under a trademark, design, trade name or other name or mark owned or controlled by the person and
  • is responsible for designing, manufacturing, assembling, processing, labelling, packaging, refurbishing or modifying the device, or for assigning to it a purpose, whether those tasks are performed by that person or on their behalf
Public health official

Is the:

  • Chief Public Health Officer appointed under subsection 6(1) of the Public Health Agency of Canada Act
  • Chief Medical Officer of Health, or equivalent, of a province
  • Surgeon General of the Canadian Armed Forces
  • Chief Medical Officer of Public Health for the First Nations and Inuit Health Branch of Indigenous Services Canada or
  • Chief Medical Officer of the British Columbia First Nations Health Authority
Regulatory agency

A government agency or other entity outside Canada that:

  • has a legal right to control the manufacturing, use or sale of medical devices within its jurisdiction and
  • may take enforcement action to ensure that medical devices marketed within its jurisdiction comply with the applicable legal requirements
UPHN medical device

A medical device that:

  • is set out in Part 1 of the UPHN list or
  • belongs to a category of medical devices that is set out in Part 2 of the UPHN list

Note about guidance documents in general

Guidance documents provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. They also provide guidance to Health Canada staff on how mandates and objectives should be met fairly, consistently and effectively.

Guidance documents are administrative, not legal, instruments. This means that flexibility can be applied. However, to be acceptable, alternate approaches to the principles and practices described in this document must be supported by adequate justification. They should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.

As always, Health Canada reserves the right to request information or material, or define conditions not specifically described in this document, to help us adequately assess the safety, effectiveness or quality of a medical device. We are committed to ensuring that such requests are justifiable and that decisions are clearly documented.

This document should be read along with the relevant sections of the Regulations and other applicable guidance documents.

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