Guidance on Medical devices for an urgent public health need: Overview

On this page

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

Purpose

On January 3, 2024, the Regulations Amending the Medical Devices Regulations (Medical Devices for an Urgent Public Health Need) (regulations) came into force. They are located in Part 1.1 of the Medical Devices Regulations (MDR). This document provides guidance on the regulations in Part 1.1.

These regulations:

• broadened the scope of Part 1.1 of the MDR beyond COVID-19, to apply to any medical condition for which the Minister has reasonable grounds to believe that it:
  • presents, or is the result of, a significant risk to public health in Canada and
  • requires immediate action to deal with the risk
• enable accelerated access to medical devices for which there is an urgent public health need (UPHN medical devices) in Canada without relying on temporary regulatory measures
• provide predictability and stability to Health Canada as a regulator as well as to manufacturers, importers and distributors of UPHN medical devices

Scope and application

This document is for medical device manufacturers, importers and distributors who import, sell or distribute medical devices manufactured, sold or represented for an urgent public health need in Canada.

The regulations:

• apply to 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 an urgent public health need to diagnose, treat, mitigate or prevent these medical conditions

This guidance explains how to apply for an authorization to import or sell UPHN 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 application type guidance document.

Policy objectives

This guidance aims to:

• help manufacturers prepare the documentation necessary to obtain authorization for importing or selling a 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
• outline the additional requirements and fees that authorization holders will need to comply with when their device is no longer a UPHN medical device

This guidance also outlines:

• the requirement for a manufacturer to report incidents to Health Canada about medical devices, as soon as they become aware of them
• a manufacturer's obligation for recalls, should they need to recall a device
• the post-market responsibilities that authorization holders have concerning the ongoing safety and effectiveness of their UPHN medical device
• the requirements for importers and hospitals to report medical device incidents involving medical devices authorized under Part 1.1

Policy statements

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

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

• new medical devices that are on the List of medical devices for an urgent public health need (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 (expanded use list) for existing devices licensed or authorized under the MDR
• 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 benefit from certain flexibilities for as long as their medical device is a UPHN medical device. Examples of flexibilities include exemptions from medical device establishment licence requirements for Class I manufacturers, requirements for a specific quality management system certificate and paying fees.

Once there is no longer an urgent public health need for a medical device, either the:

• medical device will be removed from Part 1 of the UPHN list or
• category of devices will be removed from Part 2 of the UPHN list

When a device is no longer a UPHN medical device, Part 1.1 of the MDR allows:

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

Definitions

Terms 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.

Distributor

A person, other than a manufacturer, an importer or a retailer, who sells a medical device in Canada for 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.

List of medical devices for an urgent public health need (UPHN list)

The List of medical devices for an urgent public health need 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 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 or territory
• 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 manufactured, sold or represented for use in relation to the corresponding medical condition set out in column 1 of the UPHN list and:

• 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.