ARCHIVED Medical devices for use in relation to COVID-19: Authorization

On this page

• Who can apply
• Determining urgent public health need
• Applications in queue
• Submitting an application for authorization
• Issuing an authorization
• Submitting an amendment to an authorization
• Refusal
• Terms and conditions
• Additional information and material
• Expanded use indications
• Service standards for applications for COVID-19 medical devices
• Requirements for importers and distributors
• Advertising

Who can apply

A manufacturer may only submit a new application for authorization for the following COVID-19 medical device under Part 1.1 of the MDR:

• a medical device set out in Part 1 of the List of Medical Devices for an Urgent Public Health Need in Relation to COVID-19 (UPHN list) or
• a medical device that belongs to a category of medical devices set out in Part 2 of the UPHN list

Manufacturers wishing to obtain a licence for importing or selling a medical device that is not on the UPHN list must use the licensing pathway under Part 1 of the MDR to obtain:

• a medical device establishment licence (Class I)
• a medical device licence (Class II to IV)

To obtain a medical device establishment licence (MDEL) or medical device licence (MDL) under Part 1 of the MDR, refer to the following guidance documents:

• Guidance on medical device establishment licensing (GUI-0016) - Summary
• How to complete the application for a new medical device licence

Manufacturers, importers or distributors of Class I medical devices that already hold an MDEL to import or sell a device or a device that belongs to a category of devices on the UPHN list are regulated under Part 1 of the MDR. Unless the manufacturer cancels their MDEL under Part 1 and applies for an authorization for a UPHN medical device under Part 1.1, a manufacturer may not hold both an MDEL and COVID-19 authorization.

Determining urgent public health need

An urgent public health need (UPHN) exists if immediate action is required to protect or improve the health of individuals or communities in Canada.

To determine if there's a UPHN for a medical device, Health Canada considers a number of factors, including:

• the supply and demand of the medical device or a similar device to it
• the device lifecycle (how long it lasts)
• the clinical need for the device in diagnosing, treating, mitigating or preventing COVID-19
• the status of the COVID-19 pandemic in Canada
• the status of domestic emergency preparedness

Adding a device or category of devices to the UPHN list

In accordance with section 68.1 of the MDR, the Minister of Health may add:

• a medical device to Part 1 of the UPHN list if the Minister has reasonable grounds to believe that there is a UPHN related to COVID-19 for the device or
• a category of medical devices to Part 2 of the UPHN list if the Minister has reasonable grounds to believe that there is a UPHN related to COVID-19 for the devices that belong to that category

A device that is on Part 1 of the UPHN list or belongs to a category of medical devices that is on Part 2 of the UPHN list is a UPHN medical device.

A Canadian public health official (PHO) may ask to have a device or category of devices added to the UPHN list if there is an immediate need for the device in their jurisdiction.

UPHN medical devices are intended to address immediate urgent needs. Thus, the objective of authorizing a medical device under Part 1.1 of the MDR is not for the sole purpose of creating stockpiles. Licensed devices are accessed through Part 1 of the MDR, and this avenue should be adequate for stockpiling.

To access the latest version of the list, please refer to the UPHN list.

Archived UPHN lists

The UPHN list is archived every time there is a change.

A change is:

• when a device or category of devices is added to the list
• when a device or category of devices is removed from the list
• if a reference to a device on the list is modified or
• when the description of a category of devices is modified

When there is a change in the UPHN list, Health Canada will contact those authorization holders that are affected. We will inform them about the additional requirements that they must comply with to continue to import or sell their medical device. The requirements that the authorization holder must comply with will differ depending on the class of the device.

Applications in queue

An application that was submitted to the Minister under IO No. 3 for which a decision had not been made before the Regulations came into force is an application under Part 1.1 of the MDR.

This includes:

• applications for authorization to import and sell a COVID-19 medical device
• applications to amend an authorization

Devices for which a decision had not been made before the Regulations came into force will be included on the UPHN list under the following category:

"medical devices that do not belong to any other category of medical devices set out in Part 2 of the List for which an application for an authorization was submitted to the Minister under IO No. 3 before the day on which Part 1.1 of the Regulations came into force, and in respect of that application:

• no decision had been made under the Interim Order before that day,
• no decision has been made under Part 1.1 of the Regulations, and
• the applicant has not withdrawn the application.

Health Canada may issue an authorization to the manufacturer if all requirements for authorization are met.

Submitting an application for authorization

An application for medical devices manufactured, sold or represented for use in relation to COVID-19 must contain sufficient information and material for the Minister to decide whether to issue a COVID-19 medical device authorization.

Health Canada will reject any applications for devices that are not on the UPHN list at the time the manufacturer submits the application.

How to submit an application

Applicants are to submit their application electronically. Please use standard table of contents format or a "question-and-answer" format, using the following criteria as headers. We have developed an application form to help with the application process. Before submitting, please ensure that a senior official of the manufacturer has signed the application.

Private label manufacturers must also apply for and obtain a medical device licence in order to sell their Class II, III or IV private label medical devices in Canada.

A private label medical device is one that is identical in every respect to a medical device manufactured by an original manufacturer and authorized by Health Canada. The one exception is that the device is labelled with the private label manufacturer's name, address, product name and identifier.

For more information, please refer to the following guidance:

• Private label medical devices

If you wish to submit a private label authorization or amendment application, please submit a private label application form (Appendix D) or private label amendment application form (Appendix E).

Submit your application by email to devicelicensing-homologationinstruments@hc-sc.gc.ca. Put 'COVID Part 1.1 application' in the subject line.

Application requirements

The following information is required in an application filed in accordance with Part 1.1 of the MDR.

Name of the device

The name of the device is the name that appears on the labelling and for which the authorization is sought under Part 1.1 of the MDR (paragraph 68.11(2)(a)). It includes any information necessary for the user to identify the device and to distinguish it from similar devices. To prevent duplication, do not file multiple submissions for the same product with Health Canada.

Class of the device

The class of the device must be provided (paragraph 68.11(2)(b)). According to the rules set out in Schedule 1 of the MDR, Class I represents devices with the lowest risk and Class IV represents devices with the highest risk. As per section 7 of the MDR, if a medical device can be classified into more than 1 class, the class representing the higher risk applies.

The rules to classify medical devices are outlined in Schedule 1 (Parts 1 and 2) of the MDR. Part 1 of Schedule 1 addresses medical devices other than in vitro diagnostics. Part 2 addresses in vitro diagnostic devices.

For further guidance on the classification of medical devices, consult:

• Guidance on the risk-based classification system for non-in vitro diagnostic devices
• Guidance for the risk-based classification system of in vitro diagnostic devices

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 family, medical device group or medical device group family, must be provided (paragraph 68.11(2)(c)).

Please refer to the definitions for each of these situations.

In the application form, enter the:

• name of the device (components, parts and/or accessories as per product label) in the first column
• identifier for the device (bar code, catalogue, model or part number) in the second column
• device risk class, if known, in the third column
• Global Medical Device Nomenclature (GMDN), if known, in the fourth column
• preferred name code, if known, in the fifth column

Manufacturer information

The name and address of the manufacturer as it appears on the device label must be provided (paragraphs 68.11(2)(d) and 68.11(2)(e) of the MDR). This includes the name and address where the device is manufactured (if different from the manufacturer on the device label). In this case, it should be listed as the legal manufacturer of the device.

Medical conditions, purposes and uses of the device

A description of the medical conditions, purposes and uses for which the device is manufactured, sold or represented is required (paragraph 68.11(2)(f) of the MDR).

A manufacturer of a device that meets the definition of a COVID-19 medical device (section 68.01 of the MDR) must clearly indicate in the labelling the device's use for diagnosing, treating, mitigating or preventing COVID-19.

This information is crucial in establishing an understanding of the device and the device classification.

Include the following information in this section:

• intended purpose, mechanism of action, indications for use and conditions for which the device is used in relation to COVID-19
  • the 'intended use' statement should be verbatim as it appears on the device labelling
• patient population for which the device is intended, including age range, if applicable, and specific diagnoses
• anatomical and physiological particulars related to the patient using the device, if applicable
• if the device uses an energy source and if energy is transferred to the patient
• the document version number and the date where the formal intended use appears
  • for example, the 'instructions for use' or a package insert that is provided for the end-user

Safety and effectiveness information

Information on the safety and effectiveness of the device is required (paragraph 68.11(2)(g) of the MDR).

The applicant must provide all information on the safety and effectiveness of the device.

The following examples are a guide to the type of information that should be submitted. The Minister, under section 68.23 of the MDR, may request additional information, if this is needed in order to render a decision on whether to grant an authorization.

The applicant should provide:

• a clear description of the device, including how it works, any accessories to be used with it and diagrams/photos of the device
• clinical evidence to support its intended use(s)
• a discussion of whether any components are manufactured using additive manufacturing
  • for example, fused deposition modelling, stereolithography, laser sintering, bioprinting
• evidence of biological safety if the device is manufactured from or incorporates animal or human tissue or their derivative
• a summary of the following:
  • mechanical/bench testing data performed for the device
  • animal testing and clinical investigations carried out with the device
  • biocompatibility testing performed with the device, if applicable
    • includes biocompatibility testing for any materials that come in contact with a patient for any period of time
  • evidence of shelf-life and packaging validation testing, if applicable
  • electrical safety and electromagnetic compatibility (EMC) testing, if applicable
  • the software verification and validation testing performed
    • including the final software version number and any outstanding anomalies if the medical device is or includes software
• marketing materials, if the device is to be used at point of care or sold directly to a consumer
• 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

The applicant should also provide:

• a list of applicable standards used in to design/manufacture the device
• incidents with a discussion of each event and response from the manufacturer
• a comparison table outlining technological differences between this device and predecessors that are or were licensed or authorized in Canada, if applicable
• a comparison table outlining technological differences between the proposed COVID-19 medical device and any available (authorized) comparators, to the applicant's knowledge
• analytical and clinical 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
  • flex studies assessing robustness of a device
  • stability of samples
  • preliminary reagent stability
  • information on the swab included with an in vitro diagnostic device, if applicable
  • clinical validity and usability studies, if applicable

Medical devices may impact diverse subpopulations differently. Clinical evidence (if available) should include a discussion of how data has considered sex, gender, gender-diverse people, race and ethnicity in a disaggregated manner.

For more information, please refer to the following section of the Guidance on clinical evidence requirements for medical devices :

• Clinical data that is representative of the population

For information specific to your device, please consult with the following applicable guidance documents:

• Testing devices for COVID-19
  • nucleic acid testing
  • antigen testing
  • serological testing
  • point-of-care and self-testing devices
  • test swabs
• Personal protective equipment for COVID-19
  • medical masks and respirators
  • medical gowns
  • medical gloves
  • face shields
• UV decontamination devices

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

Quality information

For devices that are on the UPHN list, manufacturers do not have to provide a Medical Device Single Audit Program (MDSAP) issued quality management system (QMS) certificate with their application. However, they must provide evidence that establishes that there is a QMS in place for the device to demonstrate that their products are of consistent quality and effectiveness.

To comply with paragraph 68.11(2)(h) of the MDR, manufacturers may provide Health Canada with:

• an MDSAP-issued QMS certificate
• a copy of the manufacturer's accredited QMS certificate to demonstrate conformity to ISO 13485:2016 or
• evidence and proper implementation of good manufacturing practices (GMP)

An ISO 13485:2016 QMS certificate is issued by a registrar who is accredited by an International Accreditation Forum (IAF) member accreditation body. The registrar and the accreditation body must have authorized scopes for medical devices.

The submitted ISO 13485:2016 QMS certificate should be issued to the manufacturer listed on the application form. If the manufacturer listed on the certificate does not match Section 2 of the application form, the applicant must complete a quality checklist in addition to providing the applicable QMS certificates.

If there is no valid ISO 13485:2016 certificate, manufacturers should at least provide:

• a completed quality checklist
  • refer to Appendix 1 of the COVID-19 application form for authorization of importation or sale of medical devices
• objective evidence to support the following items (design, planning, purchasing controls, manufacturing/production, and corrective actions and post-market activities)
  • should include the relevant procedures as well as the associated records demonstrating implementation of the QMS

Design

A documented process for controlling design and development should include:

• relevant planning stages
• identification of design inputs and product and performance requirements
• risk management activities associated with the device and its use
• identification, review and approval of design outputs
• validation of design
• control of design changes (including review and approval)
• design transfer into production

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:

• final approved specification for the product and all components, including labelling, instructions for use, packaging and device master file
• complete manufacturing/production process
• implementation of risk mitigation measures in manufacturing/production
• complete test and acceptance activities, including pass/fail criteria, for the device and all components
• validation of test and inspection methods, including statistical rationale as appropriate
• specifications for infrastructure
  • for example, controlled environments, water for injection/deionized water, refrigerated storage, biocontrol hoods, material flow
• identification of retained samples required to assist stability studies and post-market investigations
• competence/training requirements, as necessary
• process validation requirements
  • for example, master validation plan

Purchasing controls

Evidence of adequate purchasing controls should include:

• approved specifications for purchased components, products and services
• acceptance criteria and planned verification of purchased components, products and services
• documented process and procedures for evaluation and qualification of suppliers
• evidence of supplier evaluation and qualification

Manufacturing/production

Documented procedures and work instructions are required for:

• all manufacturing activities
• all in-process inspections and tests
• maintaining traceability, including results of tests and inspections and environmental conditions as necessary
  • for example, preparation of the device master record)
• identification of product status
  • for example, in-process, under review, nonconforming, released
• final review of production records and final product release
• identification and calibration of test equipment, fixtures, jigs and so on
• inventory control
• service and installation activities, as required
• handling, storage and distribution, including record keeping

Corrective actions and post-market activities

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

• identification, analysis and monitoring of data sources to identify nonconformities or potential nonconformities
• handling/disposition of in-process nonconformities
  • for example, material review board, out of spec procedure
• receiving, evaluating and investigating feedback
  • for example, handling complaints
• detecting, evaluating and investigating nonconformities
• corrections and actions to prevent the recurrence of nonconformities, including verification of effectiveness
• reporting adverse events to Health Canada
  • for example, mandatory problem reporting
• conducting and reporting advisory notices, corrections and removals to Health Canada
  • for example, recall procedures, foreign risk notifications, annual summary reporting

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

Directions for use

The applicant must provide the directions for use (paragraph 68.11(2)(i) of the MDR), unless directions are not required for the device to be used safely and effectively. Consumers and/or health care providers use this information to ensure they do not cause unnecessary harm to themselves or another person and to achieve the desired result. Users should be able to understand the directions.

For devices sold to the public, the directions for use must be on the label and must be in both English and French.

For all other devices sold in Canada, the directions for use must in either English or French. However, the manufacturer must provide the directions for use in the other official language as soon as they receive a request from a purchaser.

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.

The label should clearly indicate the control or version number.

Attestation for post-market oversight

To comply with paragraph 68.11(2)(j), the applicant must attest that documented procedures are in place for distribution records, complaint handling, incident reporting and recalls.

Find examples of an attestation form in the following:

• Appendix B
• application form

Device label

The applicant must include a copy of the device label that complies with the labelling requirements in the MDR (paragraph 68.11(2)(k)), specifically sections 21 and 23.

For more information on the requirements for labelling medical devices, including COVID-19 medical devices, please consult the following guidance documents:

• Guidance for the labelling of medical devices, not including in vitro diagnostic devices
• Guidance document - Labelling of in vitro diagnostic devices

These requirements are similar to provisions that were in IO No. 3, but will now require that labels be legible and easily understood by the user. Authorization holders that do not currently meet these requirements have 6 months from the date the Regulations came into force to comply with the labelling requirements under the MDR.

Materials

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 (paragraph 68.11(3)(a) of the MDR).

International marketing history

As per paragraph 68.11(3)(b), for Class III and IV COVID-19 medical devices, the applicant must provide:

• a list of countries (can also include regions) other than Canada where the device has been sold, and if the authorization is specific to COVID-19
• the total number of units sold in those countries by date for at least the last 5 years
• a summary of any reported problems and recalls with the device in those countries during the same time period as reported sales

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

To help Health Canada review the application, the applicant may provide information on other current or previous authorizations for sale in Canada (for example, through Part 2 or 3 of the MDR).

Foreign regulatory approval

As set out in subsection 68.11(4) of the MDR, an applicant may omit information required by paragraphs 68.11(2)(g), 68.11(2)(h) and subsection 68.11(3), as outlined above. They must, however, provide evidence that their COVID-19 medical device has an authorization or licence for sale of the device by a regulatory agency that is on the List of Regulatory Agencies for the Purposes of Subsection 68.11(4) of the Medical Devices Regulations.

For the purpose of a device's UPHN, regulatory agencies on this list are considered to have requirements that equal or exceed the following Health Canada requirements:

• regulatory pre-market COVID-19 application requirements
• review processes and standards, including similar evidence accepted for review for safety and effectiveness
• post-market surveillance mechanisms to detect, assess and respond to safety and effectiveness issues after market distribution

The application would need to include information that demonstrates the authorization or licence issued by the regulatory agency has not been suspended or revoked.

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

If the Minister considers that the evidence of approval by the regulatory agency is not enough to ensure that section 68.12 has been met, the Minister may ask for additional information under section 68.23.

A waiver of all pre-market submission and evaluation requirements by a regulatory agency is not considered a foreign regulatory approval.

Issuing an authorization

The Minister will issue an authorization for importing or selling a COVID-19 medical device if the following requirements are met:

• The manufacturer of the device submitted an application that meets the applicable requirements.
• There is a UPHN for the device (the device is on the UPHN list or the device belongs to a category of devices that is on the UPHN list).
• After reviewing the application, the Minister has concluded that the applicant provided sufficient evidence to support the conclusion that the benefits outweigh the risks associated with the device. This decision takes into consideration:
  • the uncertainties related to the benefits and risks
  • the urgent public health need for the device
• After reviewing the application, the Minister has sufficient evidence that the manufacturer has an adequate QMS in place. The QMS must be adequate to:
  • control the quality and, if applicable, the purity and sterility of the device and materials used to manufacture the device
  • ensure that the COVID-19 medical device is manufactured in accordance with the device's specifications
• The Minister determines that the health or safety of patients, users or any other person will not be unduly affected by the device (also takes into consideration the UPHN of the device).

Health Canada publishes and maintains the following lists of COVID-19 medical devices that are authorized for sale or importation in Canada:

• List of authorized testing devices
• List of authorized medical devices other than testing devices

Submitting an amendment to an authorization

When to submit an amendment

No person may import or sell a COVID-19 medical device if the device has been subject to significant differences from that which was initially submitted to the Minister for authorization (section 68.13). The onus is on the authorization holder to identify and communicate these changes to Health Canada.

An authorization may be amended whether or not the COVID-19 medical device is on the UPHN list. However, amendment fees will apply if the amendment application is submitted when the device is not on the UPHN list.

Changes that require an amended authorization are as follows:

• a significant change for a class III or IV device
• a change in classification of the device
• a change in the name of the manufacturer
• a change in the name or identifier of the device
• for a Class II device, a change in the medical conditions, purposes or uses for which the device is manufactured, sold or represented for diagnosing, treating, mitigating or preventing COVID-19

To change the purpose of their Class II to IV medical device to be unrelated to COVID-19, an authorization holder must submit an application for an MDL under Part 1 of the MDR to continue to import or sell the device.

For more information on submitting an application for a new medical device licence, consult:

• Guidance on how to complete the application for a new medical device licence

Manufacturers with an existing authorization are to inform Health Canada of changes to an address using the amendment form.

How to submit an amendment application

The authorization holder must email a completed COVID-19 Part 1.1 authorization amendment form and a summary of the changes from what was initially approved, in electronic format to: devicelicensing-homologationinstruments@hc-sc.gc.ca. Be sure to include 'Request amendment to authorization # [include your authorization number]' in the subject line.

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

Amending an authorization

The Minister shall amend an authorization for the COVID-19 medical device if the following requirements are met:

• The authorization holder has submitted an amendment application that meets the applicable requirements.
• The Minister has concluded that the authorization holder provided sufficient evidence to support the conclusion that the benefits outweigh the risks associated with the device. This decision takes into consideration:
  • the uncertainties related to the benefits and risks
  • the urgent public health need for the device, or the absence of any such need
• The Minister has determined that the health or safety of patients and other users will not be unduly affected by the device.

Refusal

The Minister may refuse to issue or amend an authorization (section 68.16 of the MDR). These refusal authorities align with the ones found in Part 1 of the MDR.

The Minister may refuse to issue or amend an authorization if:

• the Minister has reasonable grounds to believe that:
  • the authorization holder has contravened the Food and Drugs Act (the Act) or the Regulations or
  • the device is not labelled in accordance with section 21 and 23 of the MDR or
• the manufacturer does not submit additional information, documents or material, within the time limit specified in the request, to enable the Minister to determine whether to issue or amend the authorization

The Minister may only issue an authorization if all requirements under section 68.12 of the MDR are met. If these requirements are not met, the Minister is not required to issue an authorization.

The Minister will refuse to amend an authorization if information in the amendment application indicates the manufacturer intends to change the purpose of the medical device to make it unrelated to COVID-19. This is specific to Part 1.1 of the MDR.

Terms and conditions

At any time, the Minister may impose terms and conditions on an authorization for importing or selling all classes of COVID-19 medical devices. The Minister may also amend them if needed (section 68.19 of the MDR).

The goal of imposing or amending terms and conditions is to meet at least one of the following objectives:

• maintain the safety and effectiveness of the medical device by ensuring the device continues to meet applicable safety and effectiveness requirements
• optimize the benefits and manage the risks associated with the medical device
• identify changes and manage uncertainties related to the benefits and risks of the medical device

A manufacturer must comply with the terms and conditions of the authorization. Failure to comply with any terms or conditions may result in the cancellation of your authorization (paragraph 68.21(1)(e) of the MDR).

In general, the manufacturer will have an opportunity to submit a response to the proposed terms and conditions before they come into effect. During that time, manufacturers may voice their concerns or submit suggested modifications to the proposed terms and conditions. If the manufacturer does not express any concerns or make any submissions, the proposed terms and conditions would automatically come into effect and apply to the authorization.

Additional information and material

The Minister may ask for more information or documents or any material, including samples, from applicants or authorization holders to determine whether to issue, amend or cancel an authorization (section 68.23 of the MDR). The Minister will specify a time limit within which the information, document or material must be submitted.

Expanded use indications

Some medical devices have been granted an expanded use indication related to COVID-19. These devices carry COVID-19-related diagnostic, treatment, mitigation or prevention claims based on known evidence.

Expanded use indications may only be granted to:

• a licensed medical device under Part 1 of the MDR or
• a Class II, III or IV COVID-19 medical device for which the manufacturer of the device holds an authorization under Part 1.1 of the MDR

The Minister may grant an expanded use indication to a Class II, III or IV authorized device IO. However, authorization holders wanting to expand the intended use or indications for use of their device should submit an amendment application (section 68.13 of the MDR).

As per section 68.36 of the MDR, the Minister may add a Class II, III or IV COVID-19 medical device to column 1 of the List of Medical Devices for Expanded Use in Relation to COVID-19 (expanded use list) and an expanded use to column 2. The Minister may do so if the Minister:

• has reasonable grounds to believe there is an urgent public health need related to COVID-19 for the expanded use of the device
• has sufficient evidence to support the conclusion that the benefits associated with the expanded use outweigh the risks associated with it, having regard to:
  • the uncertainties relating to those benefits and risks
  • the urgent public health need for the device and
• determines the health or safety of patients or other users will not be unduly affected by the expanded use of the device

As per section 68.37 of the MDR, the Minister publishes supplementary information on the expanded use set out in column 2 of the expanded use list of:

• a licensed medical device in column 1 or
• a Class II, III or IV COVID-19 medical device in column 1 for which the manufacturer of the device holds an authorization

Supplementary information includes:

• a statement of the expanded use
• a statement of the known and potential benefits and risks
• any supplement to the directions for use
  • unless a supplement is not required for the device to be used safely and effectively

The supplementary information pertaining to the expanded use is included under column 3.

Health Canada maintains the list and will amend it from time to time.

To access the latest version of the expanded use list, please refer to the:

• List of Medical Devices for Expanded Use in Relation to COVID-19

Request for information

The Minister may request information related to the expanded use that the medical device licence holder or authorization holder possesses or to which they have reasonable access (section 68.38 of the MDR). The Minister will specify a time limit within which the holder must submit this information.

Service standards for applications for COVID-19 medical devices

For devices on the UPHN list or that belong to a category of devices on the UPHN list, Health Canada will strive to prioritize the:

• review of amendment applications for previously authorized COVID-19 medical devices due to potential impacts to supplies in Canada
• review of applications for COVID-19 devices that meet a Canadian public health need, using existing priority review criteria

Amendment applications of authorized devices that are no longer on the UPHN list or belong to a category of devices on the UPHN list are subject to the following regular service standards:

• Service standards for medical device submission evaluations under the Medical Devices Regulations

Administrative and regulatory screening stage

During the 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 the submission of the application.

Health Canada will reject applications that are administratively incomplete. This excludes minor requests seeking more information or clarification.

Within 15 days of submission, Health Canada will either ask for more information or indicate the application is complete.

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

Review stage

During the review stage, Health Canada does a scientific assessment of the application.

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

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

Health Canada will refuse applications if:

• there is not enough evidence to complete a review
• manufacturers have not adequately responded to our request for more information by the date identified in the request

Within the review stage, 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, our review of the response to this last request is not subject to the above service standards. We will prioritize our review based on urgency and the order in which we receive responses.

The manufacturer will be given an opportunity to voice any concerns related to the Minister's decision to refuse their application before we issue our final decision. We will provide a written notice to the manufacturer informing them of our final decision following this opportunity.

Requirements for importers and distributors

Requirement for importers and distributors to hold an MDEL

Importers and distributors of COVID-19 medical devices must (paragraph 68.03(2)(b) of the MDR):

• hold an active medical device establishment licence (MDEL)
• comply with certain requirements set out in the MDR

For a detailed explanation of who needs to hold an MDEL and how to submit an application, please consult:

• Guidance on medical device establishment licences (GUI-0016)

In general, any person who imports into or sells any device (including a COVID-19 medical device authorized under Part 1.1) for human use in Canada requires an MDEL.

However, an exemption from the requirement to hold an MDEL applies in certain situations. As well, a manufacturer who holds an authorization to import or sell a Class I COVID-19 medical device under Part 1.1 of the MDR is exempt from requiring an MDEL to import or sell that COVID-19 medical device. This exemption stands as long as the COVID-19 medical device is on the UPHN list.

For more information on how to submit an MDEL application, please consult:

• Guidance on medical device establishment licensing (GUI-0016)

For questions about the MDEL process, email:

• mdel.questions.leim@hc-sc.gc.ca

Copy of authorization during importation

As per section 68.26 of the MDR, each shipment of an authorized COVID-19 medical device that is imported into Canada must have a copy of the authorization. This document will:

• be issued to the applicant upon authorization
• facilitate transport of the COVID-19 medical device(s) across the border, as it indicates the device has been authorized under Part 1.1

The manufacturer's information and device information on the device label can be cross-referenced against the authorization during importation and distribution. Importers should rely on this mechanism to demonstrate to Health Canada that a shipment containing COVID-19 medical devices should be allowed into Canada.

References to IO No. 1, IO No. 2 or IO No. 3 on the authorizations can be read to be references to Part 1.1 of the MDR.

Advertising

Health Canada will continue to allow the advertisement of all authorized COVID-19 medical devices for the purpose of sale. Section 27 of the MDR permits this activity.

For more information on advertising requirements, please refer to the Advertising requirements for drugs and medical devices webpage.