Medical devices for uses related to COVID-19

Regulatory response to COVID-19

The COVID-19 pandemic has created an unprecedented demand on Canada’s health care system and has led to an urgent need for access to health products.

As part of the government’s broad response to the pandemic, Health Canada introduced a number of innovative and agile regulatory measures. These measures expedite the regulatory review of COVID-19 health products without compromising safety, efficacy and quality standards.

These measures are helping to make health products needed for COVID-19, such as medical devices, available to Canadians and health care workers. For more information please read our regulatory response to COVID-19.

About medical devices for COVID-19

Medical devices play an important role in diagnosing, treating, mitigating or preventing COVID-19.

Typical medical devices used in relation to COVID-19 include masks, N95 respirators, gloves, gowns, ventilators and testing devices. Other relevant products may include, for example:

sterilizing devices
continuous or remote monitoring devices used to reduce the frequency or need for direct interaction of health care professionals with patients

All medical devices are grouped into 4 classes. Class I devices pose the lowest potential risk (e.g., a thermometer) and Class IV devices pose the greatest potential risk (e.g., a pacemaker). These classifications determine the path a manufacturer or importer can follow to bring their medical device for use related to COVID-19 to market in Canada.

Expedited authorization pathways for COVID-19 medical devices

A COVID-19 medical device may be approved for sale or import into Canada through several pathways. Some of these pathways existed before the COVID-19 pandemic and depend on the classification of the device. Other pathways have been created to help address COVID-19 in Canada. Health Canada reviews all COVID-19-related submissions and applications as quickly as possible without compromising patient safety.

Applicants should carefully review the pathways below to select the most appropriate authorization route for their product.

Pathway 1: Interim order authorization to import and sell medical devices related to COVID-19

Interim Order No. 2 to import and sell medical devices related to COVID-19 allows Health Canada to carry out expedited evaluations of applications for COVID-19 medical devices. This is the most effective pathway for manufacturers wanting to apply for authorization.

Important information about this pathway:

This pathway is intended for manufacturers of all classes of devices, including Class I devices such as medical masks or gowns that are not approved in Canada.
Manufacturers submit an abbreviated application to support the safety, effectiveness and quality of their medical device.
Health Canada will conduct a scientific review before authorizing the sale of these devices.
No fees apply to this pathway.
Manufacturers that receive an authorization for Class I devices under this pathway are not required to obtain a Medical Device Establishment Licence (MDEL).
The application covers a single medical device product. Separate IO authorizations are required for each product.
Medical devices authorized through this pathway are published in the lists of devices authorized under the IO.
Approved on March 1, 2021, IO No. 2 introduces new requirements for importers and distributors to hold a medical device establishment licence (MDEL) and for manufacturers to comply with bilingual labelling requirements by September 1, 2021. See the guidance document for IO No. 2 for relevant information.

To apply for authorization under IO No. 2 to import and sell medical devices related to COVID-19:

Review the guidance document on how to apply for medical devices for use in relation to COVID-19, under the IO.
If you are submitting an application for one of the following types of devices, also review the specific guidance document associated with the device:
Prepare your submission package. Each submission must include enough information, including device labelling, so that Health Canada can authorize the device.
Submit your application to the Medical Devices Directorate at hc.devicelicensing-homologationinstruments.sc@canada.ca.

For information about the authorization of medical devices in Canada, please contact the Medical Devices Directorate at hc.meddevices-instrumentsmed.sc@canada.ca.

Pathway 2: Expedited review and issuance of Medical Device Establishment Licences related to COVID-19

Health Canada is expediting the review and issuance of Medical Device Establishment Licences (MDELs) for companies requesting to manufacture Class I, or import or distribute Class I to IV medical devices in relation to COVID-19.

Important information about MDELs:

Manufacturers, importers and distributors of medical devices must have an MDEL before they can import or sell in Canada. The exceptions to holding an MDEL include:
- manufacturers that have been granted authorization under Interim Order No. 2 to import and sell medical devices related to COVID-19
- manufacturers of Class I medical devices that import or distribute solely through a person that holds an MDEL
- retailers and health care facilities, as they do not need an MDEL
An MDEL application form is required.
The fee to apply is $4,590, but the MDEL holder can qualify for a fee mitigation.
MDEL holders can sell, import or distribute multiple types of medical devices under 1 licence.

To submit an MDEL application:

Review Guidance 0016: Medical device establishment licensing and medical device establishment licensing fees.
Complete the MDEL application form (FRM-0292).
Email the completed MDEL application form to hc.mdel.application.leim.sc@canada.ca, indicating in the subject line: URGENT – COVID-19 – MDEL application for – [name of company].

For any questions related to the MDEL process, please email hc.mdel.questions.leim.sc@canada.ca.

Pathway 3: Exceptional importation and sale of certain non-compliant medical devices related to COVID-19

Certain devices that may not fully meet regulatory requirements but are manufactured according to comparable standards are being allowed into Canada. For example, this could include medical masks and respirators that may be past their expiry date or have non-compliant labelling.

This exception is provided under the second interim order for drugs, medical devices and foods for a special dietary purpose for COVID-19 .

Important information about this access pathway:

Medical devices included on the list of medical devices for exceptional importation and sale are called ‘designated medical devices.’ They are eligible for exceptional importation and sale under the IO.
Manufacturers or importers must have an MDEL or Medical Device Licence (MDL) to use the exceptional importation and sale pathway.

To submit an application for exceptional importation or sale, manufacturers and importers should:

Complete the medical devices for exceptional importation and sale request form.
Email the completed form, along with a copy of the product label to hc.medicaldevices.covid19.instrumentsmedicaux.sc@canada.ca.

Health Canada will review the request. We will inform you of our decision to add the medical device to the list of medical devices for exceptional importation and sale.

Once a medical device is on the list:

Importers must notify Health Canada at least 5 calendar days before the designated device is imported, by completing the Exceptional importation and sale notification form.
Notifications should be sent to: hc.medicaldevices.covid19.instrumentsmedicaux.sc@canada.ca.

Class II, III and IV devices

As was previously the case, Class II, III and IV devices can also have a medical device licence. This is in accordance with the Medical Devices Regulations to be imported or sold in Canada.

Reporting requirements

As with all drugs and medical devices, Health Canada will assess and monitor the safety and effectiveness of all products authorized under the interim orders. We will take immediate action if required to protect the health and safety of Canadians.

Manufacturers and importers will still be required to follow strict post-market safety requirements, such as mandatory problem reporting, recall procedures and complaint handling.

Special Access Program

Health care professionals can request access to COVID-19-related medical devices not yet licensed in Canada or authorized for sale under the interim orders. Access is through Health Canada’s Special Access Program (SAP). Applications are considered case by case.

Special notes on devices for uses related to COVID-19:

Devices are being approved for uses related to COVID-19 on an expedited basis under the terms of Interim Order No. 2 to import and sell medical devices related to COVID-19. These devices cannot be requested through SAP but can be ordered directly from the manufacturers.

Manufacturers that wish to sell or import their COVID-19 devices in Canada should refer to the authorization requirements. Manufacturers and importers cannot receive authorization for sale or import of their devices through SAP.

Health care professionals should contact SAP if they want to access COVID-19 devices not authorized for sale in Canada. Access is only allowed under the following circumstances:

for emergency use
when conventional therapies have failed, are unavailable or are unsuitable to treat a patient

For questions about medical devices through SAP, please email the program at hc.sap.devices.mdb.sc@canada.ca or call 613-946-8711. For urgent requests, please call 613-410-9186.

International engagement

During the COVID-19 pandemic, Health Canada is working closely with domestic and international partners to anticipate and meet Canadians' health product needs. This involves discussing, collaborating and leveraging resources on issues related to:

clinical trials and investigational testing
drug and medical device market authorizations
health product risk assessments
potential drug and medical device shortages

International collaboration ensures that our policies and regulatory approaches are aligned and that health products are effective and made available to Canadians quickly. For more information please visit Engaging with international partners on COVID-19.

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