Explanatory note on the Interim Order No. 2 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
• Objective
• Background
• Implications
• Consultation
• Contact us

Proposal

Interim Order No. 2 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 (IO No. 2) was made by the Minister of Health on March 1, 2021, in accordance with subsection 30.1(1) of the Food and Drugs Act. The Minister may make an interim order if immediate action may be required to deal with a significant risk, direct or indirect, to health, safety or the environment.

IO No. 2 repeals the Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19, which came into force on March 18, 2020.

This new interim order maintains many of the flexibilities of the previous 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. IO No. 2 also continues to allow the importation and sale of COVID-19 medical devices that were authorized under the previous interim order.

Further, IO No. 2 introduces new requirements for medical devices authorized under this new interim order or the previous interim order

• for importers and distributors of all medical devices to hold a medical device establishment licence (MDEL); and
• for all manufacturers, importers and distributors to comply with bilingual labelling requirements.

These new requirements align with those in the Medical Devices Regulations.

In accordance with paragraph 30.1(2)(a) of the Act, IO No. 2 will remain in effect for 14 days, unless it’s approved by the Governor in Council, in which case it would remain in effect for up to 1 year.

Objective

IO No. 2 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

• providing an expedited pathway for authorizing COVID-19 medical devices; and
• helping to facilitate access to safe and effective COVID-19 devices for health care workers and other Canadians.

Background

COVID-19

COVID-19 is a new disease never before seen in humans. It 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 disease was first detected in Wuhan, China, in December 2019. The World Health Organization (WHO) declared a global pandemic related to COVID-19 on March 11, 2020. Originally seen to be a local outbreak, COVID-19 has now affected 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 are now more than 106 million cases, and over 2 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 8, 2021, has exceeded 800 000. 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.

Global efforts are focused on identifying cases and preventing further spread.

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 Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19has been effective. For instance, over 500 authorizations for COVID-19 medical devices have been issued, including for testing devices and medical devices other than testing devices, such as personal protective equipment. This authorization pathway for COVID-19 medical devices has also 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.

As the pandemic evolves, the Government of Canada continues to evaluate Canada’s medical device supply. Without widespread immunization at this time, one of the best options for controlling the spread of the virus and managing its risks is to continue to enhance our access to COVID-19 medical devices.

The tools and flexibilities used to authorize the importation and sale of COVID-19 medical devices from the previous interim order are the most effective means for providing an expedited pathway for COVID-19 devices. They also help to facilitate people’s access to the devices they need.

Implications

Requirements carried over from the previous interim order

As was the case under the previous interim order, IO No. 2 provides for an expedited authorization pathway for COVID-19 medical devices. This contributes to ensuring Canadians have continued access to COVID-19 medical devices.

IO No. 2 continues to apply to all classes of medical devices and provides three 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 IO No. 2 without requiring the manufacturer to apply (called ‘expanded use’); and
3. authorization of new COVID-19 medical devices that have been approved by a trusted foreign regulatory authority.

IO No. 2 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

• provide flexibility and regulatory oversight to enable ongoing importation, sale and distribution of COVID-19 medical devices, including personal protective equipment;
• incorporate by reference the existing list of licensed or authorized devices for which an expanded use has been approved; and
• ensure that all authorizations for medical devices issued under the previous interim order, including any terms and conditions on those authorizations, will remain in effect.

Further, any applications that are outstanding when the previous interim order expires will still be considered under IO No. 2.

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

• impose or amend terms and conditions on authorizations; and
• ask for more information about a COVID-19 medical device submission, existing authorized device or expanded use;

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 Interim Order will not be subject to evaluation, amendment and right-to-sell fees.

New requirements

MDELs

IO No. 2 requires importers and distributors of all COVID-19 devices to

• hold an MDEL; and
• meet the requirements set out in the Medical Devices Regulations relating to establishment licences (for example, recall, complaints, and distribution records and procedures).

Importers and distributors will

• have six months from the date that IO No. 2 takes effect to obtain an MDEL and comply with relevant parts of the Medical Devices Regulations relating to MDELs;
• need to submit applications for an MDEL in enough time to accommodate the service standard of 120 calendar days; and
• be required to pay application fees, as well as annual fees, for as long as they hold an MDEL.

This new MDEL requirement will allow Health Canada to better monitor the medical device supply chain.

Under the Medical Devices Regulations, Health Canada inspects the operations of MDEL holders for various activities. This includes verifying that MDEL holders have procedures in place to maintain records and handle complaints. Inspections are important to verify that MDEL holders can

• respond to medical device quality and safety issues; and
• conduct rapid, effective recalls of problematic devices when necessary.

A six-month transition period for affected stakeholders to comply with the new requirement accomplishes two things. It

• improves oversight of the COVID-19 medical device supply chain; and
• provides time for stakeholders to meet the new requirements.

Bilingual labelling

Manufacturers, importers and distributors of all COVID-19 medical devices must comply with the labelling content provisions set out in the previous interim order. Now, they must also comply with provisions similar to those of the Medical Devices Regulations to have bilingual labelling under certain circumstances.

This requirement is expected to have minimal impact on existing devices with Interim Order authorizations. Guidance relating to the previous interim order outlined that any medical device authorized under the interim order should have bilingual labelling available as soon as possible.

All manufacturers have six months from when IO No. 2 takes effect to comply with the bilingual labelling requirements. Importers, distributors and retailers have another three months to deplete current stock of medical devices that are labelled in accordance with the previous interim order.

Medical devices authorized under the previous interim order or IO No. 2 must be brought into compliance with the new requirements within the allotted transition period. Those that do not will no longer be able to be imported or sold in Canada.

Consultation

Health Canada launched a targeted email consultation addressing the proposed regulatory approach for IO No. 2. The consultation was sent to 9 000 stakeholders, including

• manufacturers that have an authorization under the previous interim order;
• manufacturers that applied for an authorization under the previous interim order; and
• current MDEL holders.

Health Canada received 72 stakeholder responses in total.

The email-based consultation was chosen in lieu of a broader consultation to target those who were affected by the interim order. As IO No. 2 relates to authorizing products for import or sale, a decision was made to focus the consultation on the manufacturers, importers and distributors who are directly impacted by the Interim Order. These included the industry stakeholders listed above, federal government departments, provinces and territories. It was also decided that a targeted consultation with impacted stakeholders would be an efficient mechanism for seeking feedback on IO No. 2, given the urgent need to ensure continued access to devices.

Furthermore, the previous interim order had been in place and public for nearly nine months before the email consultation began. Health Canada had not received any feedback from outside these groups about the Interim Order process. The overall approach was also being largely maintained.

Some of the stakeholder responses about the Interim Order focused on operational issues, such as approval timelines, rather than the proposed regulatory approach, which was the focus of the consultation. Health Canada regularly reviews the Interim Order application and review process in order to gain efficiencies and improve timelines. Health Canada will consider these comments in its next review.

Of the comments concerning the policy approaches in IO No. 2, respondents were generally supportive of the provisions. Some stakeholders gave specific reasons for their support of the previous interim order, such as

• reduced barriers;
• reduced time to market;
• reduced costs;
• simplicity of application process; and
• flexible scientific requirements.

These provisions are being carried over as part of IO No. 2.

Respondents also provided feedback on IO No. 2 new requirements for bilingual labelling and MDELs. Most respondents did not express significant concerns with meeting these new requirements in IO No. 2. However, some international manufacturers were concerned about the new bilingual labelling requirements. Most respondents also indicated that they intend to continue marketing their COVID-19 devices after the pandemic is over.

The bilingual labelling and MDEL requirements are justified given the need for oversight over industry and the fact that these requirements exist under the Medical Devices Regulations. To mitigate these concerns, Health Canada is including transition periods to help offset the burden on industry.

Health Canada also held two stakeholder webinars and presented at the Regulatory MedTech Conference. Health Canada used these sessions to explain the proposed regulatory approach to renewing the flexibilities introduced in the previous interim order. Stakeholder feedback during these sessions was consistent with the feedback received in the email consultation. Generally, participants support Health Canada’s approach and significant concerns were not raised. The questions raised focused mainly on the same operational issues as those expressed in the written submissions.

Based on the stakeholder feedback from both the email consultation and webinars, no further changes were made to IO No. 2.

Health Canada also

• informed provinces, territories and other federal government departments of its plans for IO No. 2; and
• consulted with federal government groups that handle the procurement of medical devices for national stockpiles, including the Public Health Agency of Canada (PHAC).

PHAC expressed support for the interim order flexibilities to be continued. The provinces, territories and other federal government departments did not have any reservations.

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 14
11 Holland Avenue
Ottawa ON  K1A 0K9
Address Locator: 3000A
Email: hc.lrm.consultations-mlr.sc@canada.ca