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

On this page

• Purpose
• Scope and application
• Policy objectives
• Policy statements
• Background
• Definitions
• Note about guidance documents in general

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:

• enable manufacturers, importers and distributors to continue to import or sell COVID-19 medical devices that were authorized under IO No. 3
• provide a permanent regulatory framework for these devices
• maintain the regulatory flexibilities set out under IO No. 3 for COVID-19 authorizations while there is a UPHN for the devices
• enable new authorizations for COVID-19 medical devices and expanded use indications to be issued when there is a UPHN
• continue many of the regulatory obligations and other requirements originally set out in IO No. 3
• allow applications for authorization and amendment that were submitted under IO No. 3 to be applications under Part 1.1 of the MDR
• introduce additional requirements for long-term oversight of authorized COVID-19 medical devices once a COVID-19 medical device no longer meets a UPHN
  • in line with requirements that other medical devices are subject to in the MDR

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:

• help importers and distributors of COVID-19 medical devices understand their obligations under Part 1.1 of the MDR
• outline a manufacturer's responsibility to report incidents about COVID-19 medical devices to Health Canada, as soon as they become aware of them
• identify the requirements for importers and hospitals to report medical device incidents involving COVID-19 medical devices
• highlight the post-market responsibilities that authorization holders have, with respect to ongoing safety and effectiveness of their COVID-19 medical device
• outline the responsibilities of manufacturers of COVID-19 medical devices, should they need to recall a device authorized through Part 1.1 of the MDR

Policy objectives

This guidance document aims to:

• help manufacturers prepare the documentation necessary to obtain authorization for importing or selling a COVID-19 medical device under Part 1.1 of the MDR
• provide information to importers and distributors on their requirements under Part 1.1 of the MDR
• inform the public of medical devices with expanded use indications in relation to COVID-19
• outline the additional requirements and fees that authorization holders will need to comply with when their device does not appear on the UPHN list

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:

• new COVID-19 medical devices that are on the List of Medical Devices for an Urgent Public Health Need in Relation to COVID-19 (UPHN list) and that are not licensed or authorized for importation or sale in Canada
• expanded use indications added by the Minister to the List of Medical Devices for Expanded Use in Relation to COVID-19 for existing devices licensed or authorized under the MDR
• COVID-19 medical devices that are on the UPHN list and leverage an authorization of a device from a regulatory agency that is on the List of Regulatory Agencies for the Purposes of Subsection 68.11(4) of the Medical Devices Regulations

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:

• the manufacturer of the Class I COVID-19 medical device to continue to import or sell their medical device if they obtain a medical device establishment licence (MDEL)
• the authorization holder of a Class II to IV COVID-19 medical device to maintain their authorization if they comply with additional requirements

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:

• The first interim order (Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19) was made on March 18, 2020.
• The second interim order (Interim Order No. 2 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19) repealed and replaced IO No. 1 on March 1, 2021.
• The third interim order (Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19) repealed and replaced IO No. 2 on February 21, 2022.

Through these interim orders, Health Canada authorized:

• over 800 COVID-19 medical devices, including COVID-19 diagnostic test kits, such as:
  • rapid test kits and nucleic acid kits
• other important non-testing medical devices, such as:
  • personal protective equipment, syringes and ventilators

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.