Guidance on applications for COVID-19 medical device clinical trials under the Regulations: Overview

Published: March 2, 2022

This guidance document is for applicants who wish to:

• sell or import a COVID-19 medical device for the purposes of a clinical trial (also known as investigational testing) or
• conduct a clinical trial for a COVID-19 medical device, as authorized under the Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations (the Regulations)

The Regulations will come into effect once Interim Order No. 2 respecting clinical trials for medical devices and drugs relating to COVID-19 (IO No. 2) is repealed. The Minister of Health signed IO No. 2 on May 3, 2021.

On this page

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

Scope and application

This guidance outlines the requirements when applying for a clinical trial authorization involving a COVID-19 medical device (defined in the Regulations) and when conducting such a trial. It also provides key information for applicants and authorization holders of COVID-19 medical device clinical trials under IO No. 2.

A COVID-19 medical device clinical trial may be authorized under the Regulations or under Part 3 of the Medical Device Regulations (MDR). Those applying and whose devices are authorized under the Regulations would be exempt from the MDR, except where described in the Regulations and subject to certain modified requirements.

Similar to IO No. 2, the Regulations provide another authorization pathway to advance clinical trials by increasing efficiencies and reducing the administrative burden of certain requirements.

The Regulations offer flexibilities that were included in IO No. 2, such as:

• authorization of the clinical trial
• an expanded range of applicants in addition to manufacturers and importers who are able to apply for a medical device clinical trial authorization
  • clinicians, academic researchers and contract research organizations
• an enhanced means to obtain informed consent and the ability to conduct more decentralized (or virtual) trials

These Regulations also ensure that all authorizations, suspensions and exemptions for clinical trials issued under IO No. 2, including any terms and conditions, will remain in effect. As well, any application that was outstanding when IO No. 2 was repealed would be considered an application made under the Regulations. The Minister also maintains the ability to request more information about a COVID-19 clinical trial submission at any time.

Trials already under way (authorized under the MDR) or new trials submitted under the MDR and not authorized under IO No. 2 cannot be transitioned under the Regulations. This was the case under IO No. 2. Authorization holders continue to hold their existing authorizations under the regulatory framework for which they were approved.

The Regulations apply to COVID-19 drugs and medical device clinical trials, which are expected to be the predominant therapies for COVID-19.

For information on COVID-19 trials involving drugs, please consult the following guidance document:

• Guidance on applications for COVID-19 drug clinical trials under the Regulations

Policy objectives

The Regulations facilitate COVID-19 clinical trials, which investigate and offer patients potential medical devices for diagnosing, treating, mitigating or preventing COVID-19. They also continue to uphold patient protection and ensure the validity of results.

Policy statements

Health Canada is committed to prioritizing the review of clinical trial applications. The Regulations provide an optional expedited authorization pathway for testing:

• new COVID-19-medical devices that are not yet licensed in Canada
• COVID-19-related uses for existing devices licensed under either the Medical Devices Regulations (MDR) or Interim Order No. 2 respecting the importation and sale of medical devices for use in relation to COVID-19

Such measures respond to the continued urgent need to identify potential diagnostic, treatment, mitigation or prevention options for Canada's response to the COVID-19 pandemic. However, clinical trials involving COVID-19 medical devices must still meet high ethical research standards and safeguard the safety of patients. As such, many requirements from Part 3 of the MDR that protect those involved in trials and those who help ensure that results are reliable are duplicated in the Regulations.

To facilitate use of this pathway, we have referenced existing guidance. The process for submitting applications, amending an application and providing additional information is the same.

Where possible and where proper procedures are in place to monitor such activities remotely from the site, trial activities may include virtual recruitment, informed consent, monitoring and/or visits.

An authorization for importation or sale for the purposes of a clinical trial under these Regulations are subject to compliance. Where there is non-compliance, Health Canada will take enforcement measures.

Background

COVID-19 is the infectious disease caused by the most recently discovered coronavirus, SARS-CoV-2. This new virus and disease were unknown before the outbreak began in December 2019 and have since spread around the world. COVID-19 has been known to cause respiratory symptoms, fever, cough, shortness of breath and breathing difficulties. In more severe cases, it can cause pneumonia, severe acute respiratory distress syndrome, kidney failure and even death. Older people and those with underlying medical problems like high blood pressure, heart problems or diabetes are more likely to develop serious illness.

The World Health Organization declared a global COVID-19 pandemic on March 11, 2020. The virus has now affected most countries across the globe and continues to evolve, producing new variants worldwide.

There are a limited number of authorized therapies and vaccines to effectively treat or prevent COVID-19 in the original and/or variant forms. As such, there is still an urgent need to study such therapeutic products in clinical trials. Clinical trials represent an important step in finding safe and effective treatment options for patients.

We have developed the Regulations and this guidance document to enable medical devices that diagnose, treat, mitigate or prevent COVID-19 to be investigated efficiently within a clinical trial.

Definitions

Unless explicitly listed below or in the Regulations, all expressions in this guidance document have the same meaning as under the MDR. A full list of applicable definitions is available in section 2.1.2 of the Applications for medical device investigational testing authorizations guidance document.

Clinical trial: A study involving human subjects (participants) for the purpose of discovering or verifying the effects of a drug, a device or a food for special dietary purpose.

Clinical trial site: The location where a qualified investigator conducts or monitors clinical trial activities.

COVID-19: The coronavirus disease 2019.

COVID-19 medical device: A medical device that’s manufactured, sold or represented for use in relation to COVID-19.

COVID-19 medical device authorization: An authorization to do any of the following activities:

• import or sell a COVID-19 medical device that is to be tested in a clinical trial and
• conduct a clinical trial in respect of such a device

Incident: Any incident that involves a COVID-19 medical device tested in a clinical trial and that:

• is related to a failure of the device or a deterioration in its quality or effectiveness, or any inadequacy in its labelling or in its directions for use or
• has led to the death or a serious deterioration in the state of health of a clinical trial subject, user or other person, or could do so were it to recur

Interim Order No. 2 (IO No. 2): The Minister made the Interim Order No. 2 respecting clinical trials for medical devices and drugs relating to COVID-19 on May 3, 2021. It was published in the Canada Gazette, Part I, on May 22, 2021. IO No. 2 was repealed on February 26, 2022, and replaced by the Regulations. The Regulations came into effect on February 27, 2022.

Qualified investigator: A person who is a member in good standing of a professional association of persons entitled under the laws of a province to provide health care under their licence in that province and who:

• conducts a clinical trial or
• is the responsible leader of a clinical trial conducted by a team

Research ethics board: A body that is not affiliated with an applicant for a COVID-19 medical device authorization or a holder of such an authorization. Its principal mandate is to approve the initiation of, and conduct periodic reviews of, biomedical research involving human subjects to ensure the protection of their rights, safety and well-being.

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 by industry. 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, efficacy or quality of a therapeutic product. We must make sure that such requests are justifiable and that decisions are clearly documented.

This document should be read in conjunction with the accompanying notice and the relevant sections of other applicable guidance documents.