Explanatory note on Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19

(This note is not part of the Interim Order.)

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Proposal

Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 (the third interim order) was made by the Minister of Health on February 21, 2022, in accordance with subsection 30.1(1) of the Food and Drugs Act (the Act). The Minister may make an interim order if immediate action is required to deal with a significant risk, direct or indirect, to health, safety or the environment.

The Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 (first interim order) was made on March 18, 2020. It was approved by the Governor in Council (GIC) on March 24, 2020. It was repealed on March 1, 2021, and replaced with Interim Order No. 2 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 (second interim order), which was approved by the GIC on March 15, 2021. The third interim order repeals the second interim order.

This third interim order maintains all of the flexibilities of the second interim order, including the consideration of urgent public health needs. These flexibilities are needed to assess evidence that demonstrates the safety and effectiveness of medical devices. The third interim order also continues to allow the importation and sale of COVID-19 medical devices that were authorized under the previous interim orders.

In accordance with paragraph 30.1(2)(a) of the Act, the third interim order will remain in effect for 14 days, unless it is approved by the GIC. In this case, it would remain in effect for up to 1 year.

Objective

The third interim order supports Canada's ongoing focus on dealing with the significant risk that COVID-19 continues to pose to the health and safety of Canadians. It contributes to securing Canada's medical device supply chain by:

Background

COVID-19

COVID-19 is an infectious respiratory disease caused by a strain of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). COVID-19 infection has been known to cause respiratory symptoms, fever, cough, shortness of breath and breathing difficulties. In more severe cases, it may cause pneumonia, severe acute respiratory syndrome, kidney failure and death.

The World Health Organization (WHO) declared a global pandemic related to COVID-19 on March 11, 2020, with COVID-19 now affecting the majority of countries across the globe. According to the COVID-19 Dashboard by the Center for Systems Science and Engineering at Johns Hopkins University, there have been more than 379 million cases and over 5.6 million people have lost their lives. According to the outbreak update from the Government of Canada, the number of confirmed cases in Canada as of February 1, 2022, has exceeded 3 million and over 33,000 people in Canada have lost their lives. However, the situation continues to evolve and change.

From the outset, the COVID-19 pandemic has created challenges in global supply chains, including an unprecedented demand for certain medical devices. Medical device manufacturers and importers adapted quickly to meet demands for COVID-19 devices. New manufacturers also stepped in to create additional capacity.

Combined global efforts continue to identify ways to contain the pandemic and prevent further spread as well as find effective treatments and cures against this disease.

Government of Canada's response

The health and safety of Canadians is the Government of Canada's top priority during the COVID-19 pandemic. The government therefore took action to provide a faster way to authorize the importation and sale in Canada of medical devices that are used to diagnose, treat, mitigate or prevent COVID-19.

The first and second interim orders have been effective. For instance, over 770 authorizations for COVID-19 medical devices have been issued, including 107 testing devices, such as rapid test kits, and over 660 medical devices other than testing devices, such as personal protective equipment. This authorization pathway for COVID-19 medical devices has helped to secure Canada's medical device supply chain. It did so by facilitating continued expedited access to safe and effective COVID-19 devices for health care workers and other Canadians.

Health Canada had previously notified stakeholders of a proposed approach to introduce transition regulations. This would have ceased the expedited authorization pathway, but extended current authorizations until industry could meet certain requirements to transition to the Medical Devices Regulations.

As the pandemic is evolving, the Government of Canada continues to evaluate Canada's medical device supply. With the emergence of variants such as Omicron, one of the best options for controlling the spread of the virus and managing its risks is to maintain the flexibilities provided by the expedited authorization pathway in order to continue to offer accelerated access to COVID-19 medical devices.

As a result, Health Canada has determined that at this time, a third interim order is necessary to continue to meet the needs of Canadians and industry, by enabling faster access to priority COVID-19 medical devices (e.g., test kits, N95 masks), than a transition to the Medical Devices Regulations, as previously communicated.

The tools and flexibilities used to authorize the importation and sale of COVID-19 medical devices from the previous interim orders are the most effective means for providing an expedited pathway for COVID-19 devices. The interim order pathway helps to facilitate access by health care workers and other people to the devices they need.

Implications

Requirements carried over from the previous interim order

As was the case under the second interim order, the third interim order provides for an expedited authorization pathway for COVID-19 medical devices. This contributes to ensuring Canadians have continued access to COVID-19 medical devices.

The third interim order continues to apply to all classes of medical devices and provides 3 authorization mechanisms:

  1. an expedited authorization pathway for importing and selling new COVID-19 medical devices
  2. expanded use indications for devices authorized under the Medical Devices Regulations or the third interim order without requiring the manufacturer to apply
  3. authorization of new COVID-19 medical devices that have been approved by a trusted foreign regulatory authority

The third interim order still allows the Minister to determine the level of evidence required to demonstrate the safety and effectiveness of devices authorized through the interim order, in light of the urgent public health need. This new interim order continues to also:

Further, any applications that are outstanding when the previous interim order expires will still be considered under the third interim order.

All authorized COVID-19 devices are subject to post-market requirements. These include incident reporting, reporting of a voluntary recall and record-keeping requirements related to distribution.

The Minister also maintains the ability, at any time, to:

Health Canada will continue to monitor the safety and effectiveness of authorized COVID-19 devices. This includes taking immediate action, such as cancelling authorizations if required, to protect people's health and safety.

Manufacturers of medical devices authorized under the third interim order will not be subject to evaluation, amendment and right-to-sell fees.

Consultation

The overall approach for the second interim order is being maintained in the third interim order. As such, information gathered from the targeted email consultation for the development of the second interim order and related transition regulations, held from November 2020 to January 2021, helped to inform the third interim order. This consultation process also included 2 stakeholder webinar sessions, as well as a presentation at the Regulatory MedTech Conference. The email consultation was sent to 9,000 stakeholders, including:

Federal government departments, and provinces and territories were also consulted on the development of the second interim order. Furthermore, the first and second interim orders have been in place and public for nearly 2 years before the third interim order took effect. Health Canada has not received any other feedback about the interim orders from outside the stakeholder groups listed above.

Health Canada received 72 stakeholder responses in total. Of the consultation comments concerning the policy approaches in the second interim order, respondents were generally supportive of the provisions. Some stakeholders gave specific reasons for their support of the first interim order, such as:

Respondents also provided feedback on the second interim order's bilingual labelling requirement. While most respondents did not express significant concerns with meeting the requirement in the second interim order, some international manufacturers were concerned. The bilingual labelling requirement is justified given the need for oversight over industry and the fact that the requirement exists in the Medical Devices Regulations. To mitigate these concerns, Health Canada provided transition periods in the second interim order to help offset the burden on industry. The bilingual labelling requirement has now been in place since March 1, 2021, and the transition periods have now elapsed.

Based on the stakeholder feedback from both the email consultation and webinars, no further changes were made to the second interim order. The third interim order maintains all of the second interim order's flexibilities.

Health Canada also informed provinces, territories, other federal government departments and stakeholders of its plans for the third interim order.

Contact

Bruno Rodrigue
Executive Director
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Health Canada
Holland Cross, Suite P2108
11 Holland Avenue
Ottawa, ON K1A 0K9
Address Locator: 3000A
Email: lrm.consultations-mlr@hc-sc.gc.ca

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