Applications for medical devices under the Interim Order for use in relation to COVID-19: Guidance document

Foreword

Guidance documents are meant to provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. Guidance documents also provide assistance to staff on how Health Canada mandates and objectives should be implemented in a manner that is fair, consistent, and effective.

Guidance documents are administrative instruments not having force of law and, as such, allow for flexibility in approach. Alternate approaches to the principles and practices described in this document may be acceptable provided they are supported by adequate justification. Alternate approaches should be discussed in advance with the relevant programme area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.

As a corollary to the above, it is equally important to note that Health Canada reserves the right to request information or material, or define conditions not specifically described in this document, in order to allow the Department to adequately assess the safety, efficacy, or quality of a therapeutic product. Health Canada is committed to ensuring 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.

Table of contents

Introduction

Purpose/overview

Health Canada has revised this guidance document in order to support Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19. This Interim Order (IO) was made in accordance with subsection 30.1(1) of the Food and Drugs Act. As of February 21, 2022, IO No. 3 replaces IO No. 2 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19. IO No. 3 will allow the department to continue to issue expedited authorizations for the sale or import of medical devices related to COVID-19. This is needed to deal with the current significant risk of COVID-19 to the health and safety of Canadians.

Scope and application

This guidance for manufacturers explains how to apply to sell or import medical devices that are manufactured, sold or represented for use in relation to COVID-19. Included are devices that are part of a system, test kit, medical device group, medical device family or medical device group family as defined in the Medical Devices Regulations.

A device that meets the definition of a COVID-19 medical device as outlined in IO No. 3 must clearly indicate its use in relation to the SARS-CoV-2 virus. Information submitted must include the active role the device plays in the diagnosis, treatment, mitigation or prevention of COVID-19, the disease caused by the virus.

This guidance document will also:

Policy objectives

The objectives of the updated guidance document are to help:

Policy statements

Manufacturers are required to submit an application to Health Canada to obtain authorization to sell or import a COVID-19 medical device under IO No. 3. Active authorizations issued under IO No. 2 are deemed as active authorizations under IO No. 3. No action is required from the manufacturer.

Outstanding applications submitted by manufacturers under IO No. 2 are deemed active applications for authorization under IO No. 3. These applications include amendments and applications for which Health Canada has yet to issue a decision. No action is required from the manufacturer.

This IO No. 3 guidance outlines Health Canada's expectations and the information required to obtain authorization to import and sell COVID-19 medical devices in Canada. We will grant an authorization under IO No. 3 only if we determine there is an urgent public health need for the importation or sale of the COVID-19 medical device.

The interim order provides an expedited authorization pathway for:

IO No. 2 introduced new requirements for importers and distributors of COVID-19 medical devices to hold an MDEL, and for manufacturers to comply with bilingual labelling requirements. Both requirements align with the MDR. From the time the second IO was introduced in March 2021, manufacturers were given 6 months to come into compliance. At this time, all manufacturers should comply with the language requirements.

This expedited authorization for sale or import does not apply to medical device licences that have been suspended due to safety or effectiveness concerns. It's not intended to permit sale or import of previously licensed medical devices where concerns about safety or effectiveness have been identified.

Note: The authorization for importation and sale is only valid for as long as IO No. 3 is in effect. All active authorizations issued under IO No. 1 or IO No. 2 are deemed to be authorizations for importation and sale under IO No. 3.

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 Wuhan, China, in December 2019.

COVID-19 has been known to cause symptoms such as:

In more severe cases, COVID-19 infection can cause pneumonia, severe acute respiratory 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.

COVID-19 spreads from an infected person to others through respiratory droplets and aerosols created when an infected person coughs, sneezes, sings, shouts or talks. The virus may also spread when a person touches another person (for instance, a handshake) or a surface or an object that has the virus on it and then touches their mouth, nose or eyes with unwashed hands.

SARS-CoV-2 will naturally develop mutations. New variants of concern include mutations that seem to make the virus more infectious. At this time, there's evidence that some variants may have an impact on certain drugs and vaccines. However, more research is needed to confirm these findings.

Health Canada has approved vaccines for COVID-19 that have been developed by manufacturers. However, devices used to address COVID-19 are still needed while vaccination is ongoing and the risk to Canadians remains significant.

IO No. 1 and this guidance document were originally developed to expedite access to medical devices that are needed to diagnose, treat, mitigate or prevent COVID-19. IO No. 1 was repealed on March 1, 2021 and was replaced by IO No. 2. IO No. 2 was later repealed on February 21, 2022 and has been replaced by IO No. 3. This guidance has been updated to reflect requirements under IO No. 3.

Guidance for implementation

Definitions

COVID-19 medical device:
A medical device that is manufactured, sold or represented for use in relation to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

Control number:
A unique series of letters, numbers or symbols, or any combination of these, that is assigned to a medical device by the manufacturer and from which a history of the manufacture, packaging, labelling and distribution of a unit, lot or batch of the device can be determined.

Distributor:
A person, other than a manufacturer, an importer or a retailer, who sells a medical device in Canada for the purpose of resale or use, other than for personal use. A person outside of Canada selling medical devices into Canada is also considered to be a distributor.

Foreign regulatory authority:
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 that may take enforcement action to ensure that medical devices marketed within its jurisdiction comply with the applicable legal requirements.

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.

Incident:
Any incident involving a COVID-19 medical device that

  1. 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
  2. has led to the death or a serious deterioration in the state of health of a patient, user or other person, or could do so were it to recur.

Interim Order (IO) No. 1:
The Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 was made by the Minister on March 18, 2020, and published in the Canada Gazette, Part I, on March 28, 2020. This IO was repealed on March 1, 2021 and replaced by IO No. 2.

Interim Order (IO) No. 2:
Interim Order No. 2 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19, made by the Minister on March 1, 2021, and published in the Canada Gazette, Part I, on March 19, 2021. This IO was repealed on February 21, 2022, and replaced by Interim Order No. 3 (see below).

Interim Order (IO) No. 3:
Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19, was made by the Minister on February 21, 2022, and published in the Canada Gazette, Part I, on March 12, 2022. It's currently in effect.

In vitro diagnostic device (IVDD):
A medical device that is intended to be used in vitro for the examination of specimens taken from the body.

List of medical devices for expanded use:
The list of medical devices for expanded use in relation to COVID-19 is published and maintained by the Government of Canada.

Manufacturer:
A person who:

Medical device:
A device within the meaning of the Food and Drugs Act, but does not include any device that is intended for use in relation to animals.

Medical device family:
A group of medical devices that are made by the same manufacturer, that differ only in shape, colour, flavour or size, that have the same design and manufacturing process and that have the same intended use.

Medical device group:
A medical device comprising a collection of medical devices, such as a procedure pack or tray, that is sold under a single name.

Medical device group family:
A collection of medical device groups that are made by the same manufacturer, that have the same generic name specifying their intended use, and that differ only in the number and combination of products that comprise each group.

Name of the device:
In respect of a medical device, includes any information necessary for the user to identify the device and to distinguish it from similar devices.

Recall:
In respect of a medical device that has been sold, means any action taken by the manufacturer, importer or distributor of the device to recall or correct the device, or to notify its owners and users of its defectiveness or potential defectiveness, after becoming aware that the device:

Regulations:
Refers to the Medical Devices Regulations.

System:
A medical device comprising a number of components or parts intended to be used together to fulfill some or all of the device's intended functions, and that is sold under a single name.

Test kit:
An in vitro diagnostic device that consists of reagents or articles, or any combination of these, and that is intended to be used to conduct a specific test.

Authorization for importation or sale by the manufacturer

Under IO No. 3, COVID-19 medical device manufacturers are exempt from certain requirements in Part 1 of the MDR, if Health Canada has authorized the importation or sale of their device(s).

A manufacturer may submit an application for authorization under IO No. 3 (Appendix A). If an authorization is granted, the manufacturer may import or sell the COVID-19 medical device for which they hold an IO authorization in Canada. The manufacturer's information and device information on the device label can then be cross-referenced against the IO authorization during importation and distribution. The IO authorization must accompany the product during import.

The Minister may also decide to issue an expanded indication for use to a device that holds a medical device licence under the MDR or has an IO authorization. The authorization for importation or sale is valid while IO No. 3 is in effect. Active authorizations issued under IO No. 1 or IO No. 2 are deemed as authorized under Interim Order No. 3 while it's in effect.

Fees for submitting an application

In this time of public health need, Health Canada is waiving application fees for COVID-19 medical device authorizations through IO No. 3.

Quality management system requirements

Under IO No. 3, manufacturers aren't required to provide a Medical Device Single Audit Program (MDSAP) certificate with their application for a COVID-19 medical device. Manufacturers will be required to share information to demonstrate that their products are of consistent quality and effectiveness. For proof, manufacturers may provide either:

The submitted ISO 13485:2016 quality management system certificate should be issued to the manufacturer listed on the application form. If the manufacturer listed on the certificate doesn't match Section 2 of the application form, the applicant will be required to complete a quality checklist in addition to providing any applicable QMS certificates.

In the absence of a valid ISO 13485:2016 certificate, manufacturers should provide, at a minimum:

Design

A documented process for controlling design and development should include:

Relevant records of approved design outputs, risk management, and design validation should be included where available (for example, design history file).

Planning

Evidence of adequate quality planning should include:

Purchasing controls

Evidence of adequate purchasing controls should include:

Manufacturing/production

Documented procedures and work instructions are required for:

Corrective actions and post-market activities

Documented procedures and work instructions (as appropriate) are required for:

Submitting an application

An application for medical devices manufactured, sold or represented for use in relation to COVID-19 must contain enough information and material for the Minister to decide whether to issue a COVID-19 medical device authorization. The Minister will base the decision on the issuance criteria in section 5 of Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19. This information and material is highlighted in section 4 of IO No. 3.

Applicants can submit this information electronically. Applicants are encouraged to use standard document table of contents format or provide a "question and answer" format, using the criteria specified below as headers. We have developed an application form (Appendix A) to help with the application process.

Submit your application by email to devicelicensing-homologationinstruments@hc-sc.gc.ca. Put 'COVID IO Submission' in the subject line.

Note: Be sure that a senior official of the manufacturer has signed the application.

An importer or distributor can act as a regulatory contact or regulatory representative for a manufacturer of a COVID-19 medical device. If this is the case, they should be listed as the authorized regulatory representative(s) or contact(s) under section 4 of the application form.

Importers and distributors may send complete applications to Health Canada on behalf of a manufacturer of a COVID-19 medical device. They may also provide additional information and material that we request when we are processing an application. We will only communicate with the regulatory contact listed in section 4 of the application form while the application is in process.

The information required in an application filed in accordance with IO No. 3 is provided below.

Name of the device (paragraph 4(1)(a))
This is the name that appears on the labelling and for which the authorization shall be issued under the IO. It includes any information necessary for the user to identify the device and to distinguish it from similar devices. To prevent duplication, don't file multiple submissions for the same product with Health Canada.

Class of the device (paragraph 4(1)(b))
According to the rules set out in Schedule 1 of the MDR, Class I represents the lowest risk and Class IV represents the highest risk. For the purposes of submitting an application under the IO, when a COVID-19 medical device can be classified into more than 1 class, the class representing the higher risk applies.

Identifier of the device (paragraph 4(1)(c))
The identifier of the device, including the identifier of any medical device that is part of a system, test kit, medical device group, medical device family or medical device group family must be provided. See the definitions of each of these instances.

Manufacturer information (paragraphs 4(1)(d) and 4(1)(e))
The name and address of the manufacturer as it appears on the device label must be provided, including the address where the device is manufactured (if different). This should be listed as the legal manufacturer of the device.

Intended use of the device (paragraph 4(1)(f))
Information related to the diagnosis, treatment, mitigation or prevention for which the COVID-19 medical device is required. This information is crucial in establishing an understanding of the device and the device classification.

Include the following information in this section:

Quality, safety and effectiveness information (paragraph 4(1)(g))
The applicant must provide all information on the quality, safety and effectiveness of the device.

To clarify the type of information that should be submitted, the following non-exhaustive list is provided as a guide. The Minister, under section 9 of the IO, may request additional information, if the information provided is not enough to render a decision whether to grant an authorization under this IO.

  1. a clear description of the device, including how it works, any accessories to be used with it and diagrams/photos of the device
  2. a copy of the manufacturer's quality manufacturing system certificate, evidence of good manufacturing practices, or other
  3. a discussion of whether any components are manufactured using additive manufacturing (for example, 3D printing, laser sintering, bioprinting)
  4. evidence of biological safety if the device is manufactured from or incorporates animal or human tissue or their derivative
  5. a summary of any mechanical/bench testing data performed for the device
  6. a summary of any animal testing and clinical investigations carried out with the device
  7. a summary of any biocompatibility testing performed with the device, if applicable
  8. a summary of the evidence of shelf-life and packaging validation testing, if applicable
  9. a summary of electrical safety and electromagnetic compatibility (EMC) testing, if applicable
  10. marketing materials, if the device is intended to be used at point of care or sold directly to a consumer
  11. a description of the sterilization method and a summary of sterilization validation testing performed if the device is intended to be sold in a sterile condition
  12. a list of applicable standards used in the design/manufacture of the device
  13. incidents with a discussion of each event and response from the manufacturer
  14. a comparison table outlining technological differences between this device and predecessors that are or were licensed in Canada, if applicable
  15. a comparison table outlining technological differences between the proposed COVID-19 medical device and any available (authorized) comparators, to the applicant's knowledge
  16. a discussion of the software validation testing performed if the COVID-19 medical device is or includes software
  17. analytical validation studies if the device is or includes an in-vitro diagnostic device, such as:
    • specimen validation testing
    • sample preparation validation
    • the limit of detection, when applicable
    • inclusivity
    • cross reactivity (in silico analysis and cross reactivity testing)
    • preliminary precision results, if applicable
    • stability of samples
    • preliminary reagent stability and
    • clinical validity studies

Please review our page on medical devices for information specific to your device.

If you have questions about the type of quality, safety and effectiveness information, please contact the Medical Devices Directorate by email: devicelicensing-homologationinstruments@hc-sc.gc.ca

Directions for use (paragraph 4(1)(h))
The applicant must provide the directions for use, unless they aren't required for the device to be used safely and effectively. Consumers and/or health care providers use this information to ensure they don't cause unnecessary harm to themselves or another person and to achieve the desired result. The directions for use should be understandable to the expected users.

For complex, active or powered devices, the directions for use may require a special surgeon's instruction manual, operator's manual, or user's manual.

A control or version number should be clearly indicated in the document.

Attestation for post-market oversight (paragraph 4(1)(i))
The applicant must attest that documented procedures are in place for distribution records, complaint handling, incident reporting and recalls. We have provided an example of an attestation form in Appendix B (this information is also found in the application form in Appendix A).

Device label (paragraph 4(1)(j)
The applicant must provides a copy of the label, in both languages when applicable as per section 11 of IO No. 3. This label should be legible, permanent, prominently displayed and easily understood by users.

If a package containing a COVID-19 medical device is too small to display all the information required according to section 10 of the IO, the directions for use must accompany the device but does not need to be on the outside of the package.

Materials (paragraph 4(2)(a))
For Class III and IV COVID-19 medical devices, the applicant must provide a description of the materials used in the manufacture and packaging of the device. For any materials that come in contact with a patient for any period of time, biocompatibility testing of those materials may be required.

Marketing history (paragraph 4(2)(b))
For Class III and IV COVID-19 medical devices, the applicant must provide:

While this information may be provided in any format, summary tables are preferred.

Foreign regulatory approval (subsection 4(3))
An applicant may omit information required by paragraphs 4(1)(g), 4(2)(a) and 4(2)(b), if they provide evidence that their COVID-19 medical device has gained market approval by a foreign regulatory authority. This approval can be at the State level.

We require a copy of the formal approval letter issued by the authority, as well as any review summaries authored by the authority.

If the Minister considers that the evidence of approval by a foreign authority is not enough to ensure that section 5 of the IO has been met, the Minister may ask for additional information under section 9. The Minister may also decide to issue an authorization with terms and conditions under section 7.

A waiver of all pre-market submission and evaluation requirements by a foreign authority isn't considered a foreign regulatory approval.

Granting authorization

For Health Canada to grant authorization for importation or sale of the COVID-19 medical device to a manufacturer, all of the following conditions must be met:

  1. An application is submitted to Health Canada in accordance with subsection 4(1) and if applicable subsection 4(2) of IO No. 3.
  2. All additional requested information and material, including samples, is submitted to Health Canada upon request.
  3. After reviewing the application, Health Canada has concluded that the applicant provided sufficient evidence to support the benefits of the COVID-19 medical device, and that the benefits outweigh the risks. This decision takes into consideration the uncertainties related to the device in the context of an urgent public health need.
  4. Health Canada determines that the health or safety of patients, users or any other person will not be unduly affected.

Health Canada publishes and maintains on the following lists:

Submitting an amendment to an authorization

No person can import or sell a COVID-19 medical device if there are significant differences in the device from that which was initially submitted to Health Canada for approval under IO No. 1, IO No. 2 or IO No. 3 (section 6 of IO No. 3). The exception is if the Minister has issued an amended authorization.

These changes apply to any information submitted to the Minister under section 4 of this IO, or as a response to a request for additional information under section 9.

The onus is on the authorization holder (the manufacturer) to identify and communicate these significant differences to Health Canada. The authorization holder must email a completed IO authorization amendment form (Appendix C), and a summary of the changes to that which was initially approved, in electronic format to: devicelicensing-homologationinstruments@hc-sc.gc.ca. Be sure to include 'Request amendment to IO# (include your IO authorization number)' in the subject line.

When possible, don't submit multiple concurrent amendments for the same authorized device, as it may delay our response.

Terms and conditions

At any time, Health Canada may impose terms and conditions on the authorization for importation or sale of COVID-19 medical devices. We may also amend them, per section 7 of IO No. 3.

We expect manufacturers to respect timelines when terms and conditions have been issued. Failure to comply with any term or condition may result in the cancellation of your authorization.

Cancellation

Health Canada may cancel the authorization for importation or sale of a COVID-19 medical device if:

Health Canada will implement compliance and enforcement measures if a COVID-19 medical device authorized for importation or sale under IO No. 3 is in noncompliance.

Additional information and material

Under section 9 of IO No. 3, Health Canada may ask for additional information or material, including samples, at any time. This is done to ensure that the provisions under section 5 of the IO continue to be met. With this additional information, we may decide to issue, amend or cancel a COVID-19 medical device authorization.

Labelling

Under section 10 of IO No. 3, the following information is required on the label.

Name of the device

Each device, including a system, medical device group, medical device family, or medical device group family, must have a name. The device licence is issued for:

This name permits the user to identify it and distinguish it from other devices or device types.

Name and address of the manufacturer

If more than 1 name appears on the label, the relationship of each name to the device must be made clear (for example, in the case of private labelling agreements between the manufacturer and the distributor or importer). The device licence is issued to the manufacturer named on the label.

Identifier of the device

The identifier of the device includes the identifier of any medical device that is part of a system, test kit, medical device group, medical device family or medical device group family.

The identifier is a unique number assigned to the device by the manufacturer. It may be a catalogue number, model number or a barcode. Along with the name of the device, the identifier helps to distinguish a device from all other devices. It also provides a certain level of control and traceability in the market place.

Control number for a Class III or IV device

The control number is a unique series of letters, numbers or symbols, or any combination of these, that is assigned to a COVID-19 medical device by the manufacturer. It's used to determine the history of the manufacturing, packaging, labelling or distribution of a unit, lot or batch of finished devices.

With the control number, it's possible to trace the device from manufacture to end user, including someone in whom the device may have been implanted. Along with the name of the device and the identifier, it provides the highest degree of traceability.

All Class III and Class IV devices must have a control number. Although not mandatory for Class I and Class II devices, the control number enhances post-market traceability.

Package content

If the contents are not readily apparent, the package should specify the size, net weight, length, volume or number of units.

This requirement helps users to make an informed choice when comparing similar devices and select a size suitable for their purposes. Units should be expressed in metric or SI units (international system of units). When applicable, the material used in the device should be specified.

Sterile condition, if applicable

If the device is sterilized by the manufacturer and the manufacturer intends for it to be sold in a sterile condition, this must be indicated on the label.

Expiry date, if applicable

The expiry date is based on the component that has the shortest projected useful life or is the least stable component. The expiration date must be based on studies that demonstrate the device will perform as intended and will meet its specifications until that date. It should be expressed in the internationally accepted format (ISO 8601 Data Elements and Interchange Formats-Information Exchange-Representation of Dates and Times):

A hyphen is used to separate the 3 portions of the date.

Purpose and performance specifications

Unless they are obvious, the manufacturer must indicate what the device is intended to do and on which population subgroup it's intended to be used (for example, 'for use in adults over 18 years of age').

The purposes and uses refer to the function of the device as well as to the manufacturer's intent. This intent may be stated by the labelling claims, advertising or written/oral statements made by the manufacturer or representatives.

The intended use of some devices is obvious to users (for example, gloves). In these cases, labelling may not be necessary.

Directions for use

Directions for use are provided for the general public or health care providers to ensure they use the device properly and without causing unnecessary harm. The directions for use should be easy to understand by the intended users.

For complex, diagnostic, active or powered devices, the directions for use may require a special surgeon's instruction manual, operator's manual or user's manual.

Some devices, such as gloves, may not require directions for use because their use may be obvious.

Special storage conditions

Some devices may deteriorate rapidly under certain environmental conditions (such as temperature, humidity or light). They may need to be stored in a certain way to prevent this deterioration. Information on storage conditions and temperature (in degrees Celsius) should be provided.

Language of labels

Under IO No. 3, labelling is subject to specific language requirements as per subsections 11(2) and 11(3).

For medical devices that are sold to the publicFootnote 1 the information required under paragraphs sections 10(a) and (e) to (j) of IO No. 3 must be in both English and French. This is a requirement under subsection 11(3) of the IO. In such cases, the directions for use must be supplied in both official languages at the time of purchase.

All devices that are not sold to the public in Canada must be labelled in either English or French. As per subsection 11(2) of IO No. 3, the manufacturer must make directions for use available in the other official language as soon as possible at the request of the purchaser.

Documentation required for importation

As per section 12 of IO No. 3, each shipment of a COVID-19 medical device that's imported into Canada must have a copy of the IO authorization. This document will:

Importers should rely on this mechanism to demonstrate to Health Canada that a shipment containing COVID-19 medical devices should be allowed access into Canada. References to IO No. 1 or IO No. 2 on the authorizations can be read to be references to IO No. 3.

Incident reporting by authorization holders

Section 13 of IO No. 3 requires that the holder of the COVID-19 medical device authorization for the importation or sale of the device report to Health Canada, within 10 days of becoming aware, of all Canadian incidents that:

  1. are related to a failure of device or a deterioration in its quality or effectiveness, or any inadequacy in its labelling or in its directions for use or
  2. have led to the death or a serious deterioration in the state of health of a patient, user or other person, or could do so were it to recur

The report must include a description of the frequency and of the circumstances surrounding the incident. The description of each type of problem should be clear and any remedial or corrective actions undertaken should be explained. The submission should clearly state that the device is authorized under IO No. 3, and provide the IO authorization number in lieu of a medical device licence number.

The incident report can be submitted according to the procedure outlined in the following website:

It is expected that the authorization holder will submit a preliminary report to Health Canada within 10 days, followed by a final report once the investigation is completed.

Mandatory reporting by importers

Paragraph 2(2)(a) of IO No. 3 requires importers to comply with mandatory reporting as outlined in subsection 59(1) to section 61 of the MDR. Importers and distributors should consult the existing Guidance document for mandatory problem reporting for medical devices for information on how to comply with those sections. Importers and distributors should also note that new regulations on mandatory reporting under the MDR came into effect on June 23, 2021, at which point importers were expected to comply with the new regulations.

In cases where an importer is acting as a regulatory contact or regulatory representative on behalf of a manufacturer of a COVID-19 medical device, the importer is expected to comply with subsection 59(1) to section 61 of the MDR.

Expanded use

Sections 14 to 15 of IO No. 3 allow the Minister to grant an expanded indication for use or intended use, to include COVID-19 related diagnostic, treatment, mitigation or prevention claims based on known evidence. This expansion may be applied to COVID-19 medical devices authorized under the IO, or to medical devices licensed under the MDR.

When the Minister issues an expanded use indication, information about the authorized device and the new indication is made public. This information is published on the list of medical devices for expanded use in relation to COVID-19.

If the Minister believes that an authorization holder has information concerning the expanded use of a licensed medical device or COVID-19 medical device, the Minister may request that information from the authorization holder.

Requirement for importers and distributors to hold a medical device establishment licence (MDEL)

Health Canada now requires importers and distributors to hold an active medical device establishment licence (MDEL) to import or distribute COVID-19 medical devices under IO No. 3. We have taken this action to:

Under subsection 2(2)(a) of IO No. 3, importers and distributors of COVID-19 medical devices must hold an MDEL and comply with certain requirements set out in the MDR.

Health Canada's Guidance on medical device establishment licences (GUI-0016) provides a detailed explanation of who needs to hold an MDEL and how to submit an application. In general, any person who imports into or sells any device (including a COVID-19 medical device authorized under this IO) for human use in Canada requires an MDEL.

An exemption from the requirement to hold an MDEL applies in certain situations (consult GUI-0016 for establishment licence exemptions). As well, a manufacturer who holds an authorization to import or sell a Class I COVID-19 medical device under the IO is exempt from requiring an MDEL to import or sell that COVID-19 medical device. This requirement stands as long as the authorization under the IO for their COVID-19 medical device is active.

How to submit an MDEL application

MDEL holders are subject to other regulatory requirements, including record-keeping, reporting and inspections. Health Canada inspectors verify that the MDEL holder has the ability to conduct rapid, effective recalls of problematic devices when necessary.

Health Canada is conducting remote assessments of MDEL holders who import, distribute or manufacture COVID-related devices. Immediate suspensions of MDELs will occur when establishments don't respond to our inspectors or are unable to produce procedures for recalls, distribution records or handling complaints.

Further information is available in the  Medical Devices Compliance Program December 15, 2020 bulletin.

For more information about our national compliance and enforcement approach, please refer to the compliance and enforcement policy for health products (POL-0001).

Suspension or cancellation of an MDEL

An importer or distributor must not import or sell a COVID-19 medical device if their establishment licence has been:

MDEL fees

Importers and distributors of any medical devices (including COVID-19 medical devices) who are required to hold an MDEL must pay the associated MDEL fee. They must also comply with requirements set out in the MDR.

For more information pertaining to MDEL fees, please review the fees for the review of medical device establishment licence applications.

Recall

Devices authorized under IO No. 3 are subject to recall provisions outlined in sections 64 and 65 of the MDR. Under these provisions, manufacturers and importers must notify Health Canada if they need to recall their medical device in Canada.

Note: Any device authorized under IO No. 3 is also subject to mandatory recall provisions under the Food and Drugs Act. For guidance on to how to conduct a recall in Canada, please refer to our Guide to recall of medical devices (GUI-0054).

Service standards for Interim Order applications for COVID-19 medical devices

Health Canada will:

Service standards

The following service standards apply to all COVID-19 IO applicationsFootnote 2.

Administrative and regulatory screening stage

Health Canada validates the application for administrative completeness and examines the regulatory information within the application.

Class I, II, III and IV: 15 calendar days from submission.

Within 15 days of submission, Health Canada will either ask for more information or indicate the application is complete. If we don't receive a response to a request for more information within 10 calendar days, we will consider the applicant has withdrawn its application under IO No. 3.

If we consider the application is complete, the application passes to the review stage.

Review stage

Health Canada does a scientific assessment of the application.

Class I and II: 25 calendar days from acceptance of a complete application.

Class III and IV: 40 calendar days from acceptance of a complete application.

Health Canada will either ask for more information or issue a final decision (refusal or authorization). If the scientific assessment results in a request for more information, the further review of the response to that request is not subject to this service standard.

Appendices

Appendix A: Application form

COVID-19 application form for authorization of importation or sale of medical devices

Appendix B: Attestation form (example)

ATTESTATION

Under 4(1)(i) of Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19, an applicant is required to attest to the availability of documented procedures for certain activities. Check () the relevant attestation.

[ ] I, the Applicant, have objective evidence to establish that I have documented procedures in place with respect to distribution records, complaint handling, incident reporting and recalls. I submit this attestation in partial fulfillment of the application submission requirements of Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19.

I, as a senior official of the manufacturer of this application, hereby attest that I have direct knowledge of the item checked above and declare that these identified statements are true and that the information provided in this application and in any attached documentation is accurate and complete.

Where a person is named in Item X of this application, I hereby authorize that person to submit this application to the Minister on my behalf. I further authorize the Medical Devices Directorate to direct all correspondence relating to this application to the person named in Item X of this application.

Name:
Title:
Signature:
Date:

Appendix C: Authorization amendment form

COVID-19 medical device interim order authorization amendment form

Footnotes

Footnote 1

Devices sold to the public at a self-service display are a special case. Self-service means the user doesn't benefit from a "learned intermediary" such as a health care professional, who can explain the safe and effective use of the device. Self-service also implies sale in a variety of ways (for example, by catalogue mail order and over the internet).

Return to footnote 1 referrer

Footnote 2

Health Canada will process priority files mentioned above, based on the urgent public health need. Health Canada will process non-priority files in the order in which they are received. In the case of files received before the publication of this notice, the service standard would apply from the date of publication of this notice, not the date of receipt of the application.

Return to footnote 2 referrer

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