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 developed this guidance document in order to support Interim Order No. 2 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 pursuant to subsection 30.1(1) of the Food and Drugs Act. As of March 1, 2021, Interim Order No. 2 replaces the Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19. Interim Order No. 2 will allow the Department to continue to issue expedited authorizations for the sale or import of medical devices to deal with the current significant risk of COVID-19 to the health and safety of Canadians.

Scope and application

This document is intended to provide guidance to manufacturers to organize and submit a high-quality application in a timely manner for the sale or importation of medical devices that are manufactured, sold or represented for use in relation to COVID-19. This includes a medical device that is 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 defined in Interim Order No. 2, must clearly indicate its use in relation to the SARS-CoV-2 virus, including 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 is also intended to:

New regulatory requirements for manufacturers/authorization holders, importers and distributors of COVID-19 devices authorized under IO No. 2 are indicated by text boxes. These text boxes appear above the section that contains information on the new requirements.

Policy objectives

The objectives of the updated guidance document are

Policy statements

This section contains information about the new requirements.

Manufacturers are required to submit an application to Health Canada for the purpose of obtaining authorization to sell or import a COVID-19 medical device under Interim Order No. 2. Active authorizations issued under Interim Order No. 1 are deemed as active authorizations under Interim Order No. 2 without any action required from the manufacturer.

Outstanding applications submitted by manufacturers under Interim Order No. 1, including amendment applications, and where Health Canada has yet to issue a positive or negative decision, are deemed as active applications for authorization under Interim Order No. 2 without any action required from the manufacturer.

This guidance on Interim Order No. 2 outlines Health Canada’s expectations and the information that is required to obtain authorization to import and sell COVID-19 medical devices in Canada. Importantly, an authorization under Interim Order No. 2 will be granted only if Health Canada determines that 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:

Interim Order No. 2 introduces 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 of these changes align with requirements in the Medical Devices Regulations.

This expedited authorization for sale or import does not apply to medical device licences which are currently suspended on the grounds of safety or effectiveness concerns. It is not intended to permit sale or import of previously licensed medical devices with identified safety or effectiveness concerns.

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

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.

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

Interim Order No. 1 and this guidance document were originally developed to expedite access to medical devices that are needed for the diagnosis, treatment, mitigation or prevention of COVID-19. Interim Order No. 1 was repealed on March 1, 2021 and was replaced by Interim Order No. 2. This guidance has been updated to reflect changes made as part of Interim Order No. 2.

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

Interim Order 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. It is 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 the COVID-19 that is published by the Government of Canada on its website, as amended from time to time.

Manufacturer:
A person who sells a medical device under their own name, or under a trademark, design, trade name or other name or mark owned or controlled by the person, and who is responsible for designing, manufacturing, assembling, processing, labelling, packaging, refurbishing or modifying the device, or for assigning to it a purpose, whether those tasks are performed by that person or on their behalf.

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

  1. (a) may be hazardous to health, or
  2. (b) may fail to conform to any claim made by the manufacturer or importer relating to its effectiveness, benefits, performance characteristics or safety

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

Interim Order No. 2 provides COVID-19 medical device manufacturers an exemption from certain requirements under Part 1 of the Medical Devices Regulations, provided they have received an authorization for the importation or sale of their device(s) from Health Canada.

A manufacturer may submit an application for authorization under Interim Order No. 2 (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, which is required to 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 Medical Devices Regulations or holds an IO authorization. The authorization for importation or sale is valid while Interim Order No. 2 is in effect. Active authorizations issued under Interim Order No. 1 are deemed as authorized under Interim Order No. 2 while it is in effect.

Fees related to the submission of an application for a COVID-19 medical device authorization

To remove impediments for manufacturers in this time of public health need, Health Canada will waive all application fees for COVID-19 medical device authorizations subject to Interim Order No. 2 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19.

Quality Management System requirements related to the submission of an application for a COVID-19 medical device

To remove impediments for manufacturers in this time of urgent public health need, Health Canada does not require manufacturers to provide a Medical Device Single Audit Program (MDSAP) certificate with their application for a COVID-19 medical device subject to Interim Order No. 2. Manufacturers will be required to share information to demonstrate that their products are of consistent quality and effectiveness. This can be demonstrated by either providing a copy of the manufacturer’s Quality Management System certificate to ISO 13485:2016, or by submitting evidence of Good Manufacturing Practices and its proper implementation.

In the absence of a valid ISO 13485:2016 certificate, information supporting the following criteria, as a minimum, should be included in an application for a COVID-19 medical device:

Design

A documented process for controlling design and development. The process should include:

Relevant records of approved design outputs, risk management, and design validation should be included where available (for example, Design History File (DHF)).

Planning

Evidence of adequate quality planning, including but not limited to:

Purchasing controls

Evidence of adequate purchasing controls, including but not limited to:

Manufacturing/production

Documented procedures and work instructions for:

Corrective actions and post-market activities

Documented procedures and work instructions (as appropriate) for:

Submitting an application for the authorization of a COVID-19 medical device

An application for medical devices manufactured, sold or represented for use in relation to COVID-19 shall contain sufficient information and material for the Minister to render a decision whether or not to issue a COVID-19 medical device authorization, on the basis of the issuance criteria in section 5 of Interim Order No. 2. 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 Interim Order No. 2.

This information can be submitted electronically and applicants are encouraged to use standard document submission guidelines (i.e. the ToC format), or provide a “question and answer” style of application, using the criteria specified below as headers. An application form has also been developed to facilitate the application process. Applications are to be submitted to the following email address:

hc.devicelicensing-homologationinstruments.sc@canada.ca with the subject line: COVID IO Submission.

Important: The application must be signed by a senior official of the manufacturer.

An importer or distributor can act as a regulatory contact or regulatory representative on behalf of a manufacturer of a COVID-19 medical device. If this is the case, Health Canada expects that they be listed as the authorized regulatory representative(s) or contact(s) under section 4 of the application form. Importers and distributors can send complete Interim Order applications to Health Canada on behalf of a manufacturer of a COVID-19 medical device and can facilitate communication by providing additional information and material that is requested when processing an application.

Clarification on the specifics of the information required in an application filed in accordance with Interim Order No. 2 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 is provided below.

Name of the device
4(1)(a) of the Interim Order requires including the name of the device. This is the name that appears on the labelling proper and for which the authorization shall be issued under the Order. It includes any information necessary for the user to identify the device and to distinguish it from similar devices. In order to prevent duplication, multiple submissions for the same product should not be filed with Health Canada.

Class of the device
4(1)(b) of the Interim Order requires specifying the class of the device. This is the classification that is attributed to the device according to the rules set out in Schedule 1 of the Medical Devices Regulations. According to the classification scheme, Class I represents the lowest risk and Class IV represents the highest risk. For the purposes of submitting an application under the Interim Order, when a COVID-19 medical device can be classified into more than one class, the class representing the higher risk applies.

Identifier of the device
4(1)(c) of the Interim Order requires 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 be provided. For greater certainty, the definitions of each of these instances have been included above (see “Definitions”).

Manufacturer information
4(1)(d) and 4(1)(e) of the Interim Order requires providing the name and address of the manufacturer as it appears on the device label, including the address where the device is manufactured (if different). For greater certainty, this should be listed as the legal manufacturer of the device.

Intended use of the device
4(1)(f) of the Interim Order requires providing 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. The following information should be included in this section:

Quality, safety and effectiveness information
4(1)(g) of the Interim Order requires that the applicant provide the known information in relation to 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 to inform a submission. The Minister, under section 9 of the Interim Order, may request any additional information, if the information provided is deemed insufficient to render a decision whether to grant an authorization under this Interim Order.

  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 (3D printing, laser sintering, bioprinting, etc.)
  4. if this device is manufactured from or incorporates animal or human tissue or their derivative, evidence of biological safety of the device
  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. if the device is intended to be used at point of care or sold directly to a consumer, marketing materials for the device
  11. if the device is intended to be sold in a sterile condition, a description of the sterilization method and a summary of sterilization validation testing performed
  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. if the COVID-19 medical device is, or includes software, a discussion of the software validation testing performed
  17. if the COVID-19 medical device is, or includes an in-vitro diagnostic device, analytical validation studies including but not limited to:
    • 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

Health Canada has established some technology-specific guidance documents to support applicants; please review the Health Canada website for guidance specific to your device. If the applicant has questions specific to the type of quality, safety and effectiveness information, they are urged to contact the Medical Devices Directorate, using the following email address:

hc.devicelicensing-homologationinstruments.sc@canada.ca

Directions for use
4(1)(h) of the Interim Order requires that the applicant provide the Directions for Use, unless directions are not required for the device to be used safely and effectively. This is the information supplied to the lay person and/or the health care professional enabling them to use the device without causing unnecessary harm to themselves or another person and to achieve the desired result. The Directions for Use should be written at a level commensurate with the training of the expected users.

For some complex, active or powered devices, the Directions for Use may require a special Surgeon's Instruction Manual, Operator's Manual, and a User's Manual.

All documents should have a control or version number clearly indicated in the document.

Attestation for post-market oversight
4(1)(i) of the Interim Order requires the applicant to provide an attestation that documented procedures are in place in respect of distribution records, complaint handling, incident reporting and recalls. Appendix B provides an example of what Health Canada would look for in an attestation from an applicant (this information is also directly included in the application form in Appendix A).

Device label
4(1)(j) of the Interim Order requires that the applicant provides a copy of the label of the COVID-19 medical device, in both languages when applicable as per section 11 of Interim Order No. 2. This label should be expressed in a legible, permanent and prominent manner, in terms that are easily understood by the intended user. Additionally, where a package that contains a COVID-19 medical device is too small to display all the information required according to section 10 of the Interim Order, the Directions for Use shall accompany the device but need not be on the outside of the package or be visible under normal conditions for sale.

Materials
4(2)(a) of the Interim Order requires that, for Class III and IV COVID-19 medical devices, the applicant provides a description of the materials used in the manufacture and packaging of the device. Additionally, if there are any materials that are patient contacting for any period of time, biocompatibility testing of those materials may be required in order to render a decision on whether the Minister may issue an authorization.

Marketing history
4(2)(b) of the Interim Order requires that, for Class III and IV COVID-19 medical devices, the applicant provides a list of countries other than Canada where the device has been authorized and sold, the total number of units sold in those countries, and a summary of any reported problems with the device and any recalls of the device in those countries. This information can be provided in any format, however, summary tables are preferred.

Foreign regulatory approval
4(3) of the Interim Order stipulates that an applicant may omit the information required to be submitted in their initial application, specifically, items 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 need not be at the National level, as Health Canada may accept approval at the State level. This evidence should include a copy of the formal approval letter issued by the authority, as well as any review summaries authored by the authority. For absolute certainty, if the Minister deems that the evidence of approval by a foreign authority is insufficient to ensure that section 5 of the Interim Order is met, the Minister may request additional information under section 9 of the Interim Order, and may also decide to issue an authorization with terms and conditions under section 7.

If a foreign jurisdiction waives all pre-market submission and evaluation requirements, this would not be considered a foreign regulatory approval for the purposes of the Interim Order.

Issuance of 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 Interim Order No. 2.
  2. All additional requested information and material (including samples) is submitted to Health Canada upon request.
  3. Health Canada has assessed the submitted information and has concluded that the applicant provided sufficient evidence to support the benefits of the COVID-19 medical device and that the benefits of the COVID-19 medical device outweighs the risks associated with it. This takes into consideration the uncertainties related to the device in the context of an urgent public health need and
  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 its website a list of testing devices that have been authorized for sale or import in Canada as well as a list of medical devices, other than testing devices, that have been authorized for sale or import in Canada under Interim Order No. 2.

Submitting an amendment to an authorization for importation or sale of a COVID-19 medical device

Section 6 of Interim Order No. 2 states that 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 either Interim Order No. 1 or Interim Order No. 2, unless the Minister has issued an amended authorization. These changes apply to any information submitted to the Minister under section 4 of this Interim Order, 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. A summary of the changes, compared to that which was initially approved, must be submitted by the authorization holder to Health Canada in electronic format using the following email address:

hc.devicelicensing-homologationinstruments.sc@canada.ca with the following subject line: Request amendment to IO# (include your IO authorization number).

When possible, do not submit multiple concurrent amendments for the same authorized device, as it may delay response.

Terms and conditions

Due to the nature of the application and issuance of expedited authorizations to address with the significant public health risk of COVID-19, Health Canada may, at any time, impose terms and conditions on the authorization for importation or sale of COVID-19 medical devices, or amend them, as per section 7 of Interim Order No. 2.

Health Canada expects manufacturers to respect timelines when terms and conditions have been issued. Note that 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 under the following conditions if:

  1. Health Canada determines that the benefits no longer outweigh the risks of the device and that the health or safety of Canadian patients, users or any other person may be unduly affected
  2. Health Canada determines that the terms and conditions imposed are not met
  3. a medical device licence is issued for the COVID-19 medical device under section 36 of the Medical Devices Regulations or
  4. the authorization for sale of a COVID-19 medical device that has been issued by a foreign regulatory authority is suspended or cancelled

A COVID-19 medical device authorized for importation or sale under Interim Order No. 2 is subject to compliance and enforcement measures should Health Canada be made aware of issues of noncompliance. 

Additional information and material

As per section 9 of Interim Order No. 2, Health Canada may, at any time, request additional information or material (including samples) from the applicant in order to ensure that the provisions under section 5 of the Interim Order continue to be met. This information will be used to determine whether Health Canada will move forward with the issuance, amendment or cancellation of the COVID-19 medical device authorization.

Labelling

This section contains information about new requirements.

As per section 10 of Interim Order No. 2, the following information is required on the label.

The 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 (a) the device name on the label which may describe one device, (b) an administrative grouping of devices sold for convenience under a single name or (c) a grouping of devices that carry the same generic name specifying the intended use of the devices. This name permits the user to identify it and distinguish it from other devices or device types.

The name and address of the manufacturer

If more than one name appears on the label, the relationship of each name to the device must be made clear, such as 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.

The identifier of the device

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.

The identifier is a unique number assigned to the device by the manufacturer, which along with the name of the device, will permit a device to be distinguished from all other devices. It may be a catalogue number, model number, or a barcode and will permit, in combination with the name, a certain level of control and traceability in the market place.

Control number for a Class III or IV device

The control number means 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 and, from which the history of the manufacturing, packaging, labelling or distribution of a unit, lot or batch of finished devices can be determined. The control number allows the device to be traced from manufacture to the end user, including an individual 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.

This is a requirement for Class III and Class IV devices only. Although not mandatory for Class I and Class II devices, the control number enhances postmarket traceability.

Package content

If the contents are not readily apparent, an indication of what the package contains, expressed in terms appropriate to the device, such as the size, net weight, length, volume or number of units.

The intent of this requirement is to provide specific information describing the package contents to the user and to enable the user to make an informed choice when comparing similar devices. The information will also allow the user to select a size suitable for his/her 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 the device is sterilized by the manufacter and the manufacturer intends for it to be sold in a sterile condition, then this must be indicated on the label.

Expiry date

The expiry date of the device, if the device has one. This is to be determined by the manufacturer on the basis of the component that has the shortest projected useful life.

The life of the least stable component determines the expiration date. The expiration date must be based on the results of studies which demonstrate that the device will perform as intended and will meet its specifications until that date. The date should be expressed in the internationally accepted format (ISO 8601 Data Elements and Interchange Formats-Information Exchange-Representation of Dates and Times): year (in four digits), month (in two digits), and day (in two digits). The separator for the three portions of the date should be a hyphen (-).

Purpose and performance specifications

Unless self-evident to the intended user, the medical conditions, purposes and uses for which the device is manufactured, sold or represented, as well as the performance specifications of the device if those specifications are necessary for proper use.

This section requires the manufacturer to state succinctly what the device is intended to do and on which population subgroup the device is 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 objective intent of the manufacturer. This intent may be communicated by the labelling claims, advertising, or written or oral statements made by the manufacturer or representatives.

There are some devices that may be sold to the general public, and which often have an intended use that is self-evident to the user, for which such labelling may not be necessary (for example, gloves).

Directions for Use

The Directions for Use, unless directions are not required, for the device to be used safely and effectively.

This is the information supplied to the lay person and/or the health care professional enabling them to use the device without causing unnecessary harm to themselves or another person and to achieve the desired result. The Directions for Use should be written at a level commensurate with the training of the expected users.

For some complex, diagnostic, active or powered devices, the Directions for Use may require a special Surgeon's Instruction Manual, Operator's Manual, and a User's Manual.

There are some devices that may not require Directions for Use to be provided, as the ability to use the device is inherent in its design (for example, gloves).

Special storage conditions

Any special storage conditions applicable to the device.

Some devices may deteriorate rapidly under certain environmental conditions as they relate to temperature, humidity, or light, and may need to be stored in a specified manner to prevent this deterioration. The user must be provided with this information in order to decide if such storage conditions are accessible or within their means. Storage temperatures should be provided in degrees Celsius.

Language of labels

Under Interim Order No. 1, Health Canada accepted labelling in either English or French at the time of application for devices that were intended to be sold to the public. For professional use devices, manufacturers were encouraged to make bilingual labelling available as soon as possible, and upon request, by the purchaser. Under Interim Order No. 2, labelling will be subject to specific language requirements as per sections 11(2) and 11(3). COVID-19 medical device manufacturers have 6 months from the date Interim Order No. 2 takes effect to comply with those sections (by September 1, 2021).

Devices labelled in either English or French will continue to be authorized, but only for a limited time. Manufacturers must ensure that, following the initial 6-month period, they are in compliance with the requirements of Interim Order No. 2.

In respect of a medical device that is sold to the general public,Footnote 1 the information required by sections 10(a) and (e) to (j) of Interim Order No. 2 shall, as a minimum, be in both English and French as per section 11(3) of the Interim Order. 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 general public in Canada must be labelled in either English or French. As per section 11(2) of Interim Order No. 2, Directions for Use in the other official language shall be made available by the manufacturer as soon as possible at the request of the purchaser.

Stock-depletion of non-compliant labels for importers, distributors, retailers
As per section 18(2) of Interim Order No. 2, importers, distributors and retailers will have an additional three months following the coming into force of sections 11(2) and 11(3) (9 months after the coming-into-force of Interim Order No. 2) to deplete any existing stock of COVID-19 medical devices with non-compliant labels. Health care facilities that distribute COVID-19 medical devices are considered distributors, so long as they are not the device manufacturer.

Documentation required for importation

As per section 12 of Interim Order No. 2, each shipment of a COVID-19 medical device that is imported into Canada must be accompanied by a copy of the Interim Order authorization. This document will be issued to the applicant upon authorization and will facilitate transport of the COVID-19 medical device(s) across the border, as it will be used as a signal that the device has been authorized under the Interim Order. 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 Interim Order No. 1 on the authorizations can be read to be references to Interim Order No. 2.

Incident reporting by the authorization holder

Section 13 of Interim Order No. 2 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. (a) 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. (b) 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

A description of the frequency and of the circumstances surrounding the incident must also be provided as part of the report. 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 Interim Order No. 2, and provide the Interim Order 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:

Mandatory Medical Device Problem Reporting Form for Industry

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

Mandatory reporting by importers

This section contains information about new requirements.

Section 2(2)(a) of Interim Order No. 2 requires importers to comply with mandatory reporting as outlined in sections 59(1) to 61 of the Medical Devices Regulations. 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 Medical Devices Regulations will come into effect on June 23, 2021, at which point importers will be 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 sections 59(1) to 61 of the Medical Devices Regulations.

Expanded use

Sections 14-15 of Interim Order No. 2 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 Interim Order, or to medical devices licensed under the Medical Devices Regulations.

When the Minister decides to issue an expanded use indication, they will make information related to the authorized device and the new indication publicly available. This will be published to the List of Medical Devices for Expanded Use in Relation to COVID-19 Pandemic on Health Canada’s website. Additionally, if the Minister believes that a medical device authorization holder has any information in relation to the expanded use of the licensed medical device or the COVID-19 medical device, the Minister may request that information and the authorization holder must provide it.

Requirement for importers and distributors to hold a Medical Device Establishment Licence (MDEL)

This section contains information about new requirements.

Under Interim Order No. 1, importers and distributors were not required to hold an active Medical Device Establishment Licence (MDEL) to import or distribute COVID-19 medical devices authorized under the IO. To enable risk-based regulatory oversight on the medical device supply chain and facilitate complete and rapid recalls of problematic devices when necessary, Health Canada has added this requirement to Interim Order No. 2.

Requirement to hold an MDEL
As per section 2(2)(a) of Interim Order No. 2, importers and distributors of COVID-19 medical devices are required to hold an MDEL and comply with certain requirements set out in the Medical Devices Regulations.

COVID-19 medical device importers and distributors:

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 Interim Order) 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). In addition to those existing exemptions, a manufacturer who holds an authorization for the importation or sale of a Class I COVID-19 medical device under the Interim Order is exempt from requiring an MDEL to import or sell that COVID-19 medical device, so long as the authorization under the Interim Order 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 do not respond to Health Canada inspectors, or are unable to produce procedures pertaining to recalls, distribution records, or complaint handling. Further information is available in the December 15, 2020 Medical Devices Compliance Program Bulletin.

Additional information about Health Canada’s national compliance and enforcement approach can be found in 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, and comply with requirements set out in the Medical Devices Regulations.

For more information pertaining to MDEL fees please review the Fees for the Review of Medical Device Establishment Licence Applications.

Recall

Any device authorized under Interim Order No. 2 is subject to recall provisions under Sections 64 and 65 of the Medical Devices Regulations as per section 2(2)(b) of this Order. Under these provisions, manufacturers and importers are required to notify Health Canada if they become aware of the need to recall their medical device in Canada. In addition, it is important to clarify that any device authorized under Interim Order No. 2 is also subject to mandatory recall provisions under the Food and Drugs Act. The following link provides guidance on to how to conduct a recall in Canada: 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 to examine the regulatory information within the application.

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

To note: Within 15 days of submission, Health Canada will either ask for more information or indicate the application is complete. If we do not receive a response to a request for more information within 10 calendar days, we will consider the applicant has withdrawn its application under Interim Order No. 2.

If Health Canada considers 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.

To note: 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. 2 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. 2 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:

Footnotes

Footnote 1

Devices sold to the general public at a self-service display are a special case. Self-service implies the absence of a "learned intermediary" such as a health care professional, to assist the user in 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 via the Internet.

Return to footnote 1 referrer

Footnote 2

With the exception of priority files mentioned above, Health Canada will process 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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