Guidance on Medical devices for an urgent public health need: Authorization

On this page

• Who can apply
• Determining urgent public health need
• 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 reviewing applications
• Requirements for importers and distributors
• Advertising

Who can apply

A manufacturer may only submit a new application for authorization for the following medical device under Part 1.1 of the Medical Devices Regulations (MDR):

• a medical device set out in Part 1 of the List of medical devices for an urgent public health need (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 import or sell 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)
• 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, consult the following guidance documents:

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

Importers and distributors are required to hold an MDEL to import or sell any medical device under Part 1.1.

Manufacturers of Class I medical devices that already hold an MDEL to import or sell a UPHN medical device are regulated under Part 1 of the MDR. A manufacturer may not hold both an MDEL and Part 1.1 authorization for the same device at the same time.

Manufacturers that want to have their device regulated under Part 1.1 would have to cancel their MDEL under Part 1 and apply for an authorization for a UPHN medical device under Part 1.1.

Determining urgent public health need

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

To determine if there's an urgent public health need 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 the corresponding medical condition on the UPHN list
• the status of the public health emergency in Canada
• the status of domestic emergency preparedness

Adding a medical condition to the UPHN list

In accordance with subsection 68.1(1) of the MDR, the Minister of Health may add a medical condition to column 1 of Part 1 or Part 2 of the UPHN list.

A medical condition may be added to the UPHN list only if the Minister has reasonable grounds to believe that:

• the medical condition presents, or is the result of, a significant risk to public health in Canada and
• immediate action is required to deal with the risk

Adding a device or category of devices to the UPHN list

In accordance with subsections 68.1(2) and (3) of the MDR, the Minister of Health may add a:

• medical device to column 2 of Part 1 of the UPHN list if the Minister has reasonable grounds to believe there is an urgent public health need for the device that is related to the corresponding medical condition that is set out in column 1 or
• category of medical devices to column 2 of Part 2 of the UPHN list if the Minister has reasonable grounds to believe there is an urgent public health need for the devices that belong to that category that is related to the corresponding medical condition set out in column 1

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 may ask to have a medical condition or 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. 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 any of the following:

• when a medical condition is added to or removed from the list or
• when a device or category of devices is added to or 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.

Submitting an application for authorization

An application for medical devices manufactured, sold or represented for use for the corresponding medical condition on the UPHN list must contain sufficient information and material for the Minister to decide whether to authorize a medical device.

Health Canada will reject any new 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 authorization in order to sell their Class II, III or IV private label medical devices in Canada.

A private label medical device is identical in every respect to a medical device manufactured by an original manufacturer and authorized by Health Canada. The 1 exception is that the device is labelled with the private label manufacturer's name, address, product name and identifier.

A private label authorization under Part 1.1 can only be granted based on the original manufacturer's Part 1.1 authorized device.

For more information, consult the following guidance:

• Private label medical devices

If you wish to submit a private label authorization or amendment application, please submit either a:

• private label application form or
• private label amendment application form

Submit your application by email to devicelicensing-homologationinstruments@hc-sc.gc.ca. Include '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.

For information on which medical devices, including components and parts, can be combined together and submitted as 1 application as set out in sections 68.05 to 68.09 of the MDR, consult:

• Guidance for determining medical device application type

Medical devices, including components and parts, that cannot be combined into 1 of the combinations mentioned in the guidance must be authorized individually. They would require separate applications.

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 one 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 (paragraph 68.11(2)(d) of the MDR). This includes the name and address where the device is manufactured, if different from the manufacturer on the device label (68.11(2)(e) of the MDR). The legal manufacturer is the quality management system (QMS) holder of the medical device seeking authorization in Canada. They are responsible for designing, developing, manufacturing, assembling, processing, labelling, packaging, refurbishing or modifying the respective 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). This information is crucial in establishing an understanding of the device and the device classification.

The manufacturer of the device must clearly indicate in the labelling the device's use for diagnosing, treating, mitigating or preventing the corresponding medical condition on the UPHN list (paragraph 21(1)(h) of the MDR).

The applicant should provide the following information:

• intended purpose, mechanism of action, indications for use and conditions for which the device is used for the corresponding medical condition on the UPHN list
  • 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 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 to be sold in a sterile condition

The applicant should also provide:

• a list of applicable standards used 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 medical device and any available (authorized) comparators that the applicant knows about
• 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, consult the following section of the Guidance on clinical evidence requirements for medical devices:

• Clinical data that is representative of the population

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 UPHN medical devices, 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 any of the following:

• 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 QMS certificate, manufacturers should at least provide:

• a completed quality checklist
  • refer to Appendix 1 of the 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 the QMS has been implemented

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 nonconformities from recurring, 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. Users should be able to understand the directions.

For devices sold to the general 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 be in either English or French. However, the manufacturer must provide the directions for use in the other official language as soon as possible at the 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.

The attestation is located within the 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, 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

Materials

For Class III and IV medical devices, the applicant must provide a description of the materials used to manufacture and package 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 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 the corresponding medical condition that is on the UPHN list
• 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 or through the exceptional importation and sale framework).

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 medical device has an authorization or licence for sale by a regulatory agency. The agency must be 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 urgent public health need, regulatory agencies on this list are considered to have requirements that equal or exceed the following Health Canada requirements:

• regulatory pre-market 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 request a copy of the formal authorization 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 authorization 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 medical device if the following requirements are met:

• The manufacturer of the device submitted an application that meets the applicable requirements outlined under section 68.11 of the MDR.
• 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 concerning 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 in the manufacture the device
  • ensure that the 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.

The Minister may only issue an authorization if all requirements under section 68.12 of the MDR are met. At this point, the manufacturer will receive an authorization letter from Health Canada to import and sell the medical device. Manufacturers also may receive a conditional authorization requiring that they provide additional information within a set timeline post-authorization.

If these requirements are not met, the Minister will issue a decision not to authorize.

The decision not to authorize letter will outline the following:

• section of the MDR under which the decision is being made
• reason for the decision and
• deficiencies that need to be addressed should the manufacturer submit a new application

Health Canada publishes and maintains a list of medical devices that are authorized for sale or importation under Part 1.1 in Canada.

Submitting an amendment to an authorization

When to submit an amendment

No person may import or sell a medical device if the device has been subject to changes 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 device is a UPHN medical device. However, amendment fees will apply if the amendment application is submitted when the device is not a UPHN medical device.

Changes that require an amended authorization are a:

• significant change for a class III or IV device
• change in classification of the device
• change in the name of the manufacturer
• change in the name or identifier of the device
• change in the medical conditions, purposes or uses for a Class I or II device that is manufactured, sold or represented

The Minister will refuse to amend an authorization if the purpose of the medical device will no longer be in relation to one of the following:

• the medical condition that was on the UPHN list for which the device was first authorized
• a medical condition that was on the UPHN list for the device and was added to the authorization previously through an amendment application
• a medical condition that is on the UPHN list at the time the current amendment application is submitted

To continue to import or sell a medical device that is no longer for 1 of the medical conditions mentioned, the authorization holder of a:

• Class I device must submit an application for an MDEL under Part 1 of the MDR and pay the applicable fee or choose to import or distribute solely through an existing MDEL holder
• Class II to IV device must submit an application for an MDL under Part 1 of the MDR and pay the applicable fee

For more information on submitting an application for a new MDEL or MDL, consult:

• Guidance on medical device establishment licensing (GUI-0016)
• 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 is asked to submit a completed Part 1.1 authorization amendment form and a summary of the changes from what was initially approved, in electronic format. Submit this by email 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 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 concerning 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.

If these requirements are not met, the Minister will issue a decision not to amend an authorization. The decision not to amend the authorization letter will outline the following:

• section of the MDR under which the decision is being made
• reason for the decision
• deficiencies that need to be addressed should the manufacturer submit a new amendment application

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 manufacturer of the device has contravened the MDR or any provision of the Food and Drugs Act (the Act) or
  • the device is not labelled in accordance with section 21 and 23 of the MDR or
• the manufacturer does not submit to the Minister all information, documents or material that was requested, within the time limit specified in the request, to enable the Minister to determine whether to issue or amend the 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 such that it no longer relates to:

• the medical condition that was on the UPHN list for which the device was first authorized or
• a medical condition that was on the UPHN list for the device and was added to the authorization previously through an amendment application or
• a medical condition that is on the UPHN list at the time the current amendment application is submitted

This is specific to Part 1.1 of the MDR.

The manufacturer will receive a refusal letter that will outline the following:

• section of the MDR under which the refusal is being made
• reason for refusal
• deficiencies that need to be addressed should the manufacturer submit a new application

Terms and conditions

At any time, the Minister may impose terms and conditions on an authorization for importing or selling all classes of 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 1 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 concerning 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 the 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, documents or material, including samples, from the manufacturer of the device 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 for a medical condition on the UPHN list. These devices carry diagnostic, treatment, mitigation or prevention claims for that condition based on known evidence.

Expanded use indications may only be granted to a:

• licensed medical device under Part 1 of the MDR or
• Class II, III or IV medical device that is the subject of a Part 1.1 authorization

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 68.351 of the MDR, the Minister may add a medical condition to column 1 of the List of medical devices for expanded use (expanded use list). The Minister may do so if the Minister has reasonable grounds to believe that:

• the medical condition presents, or is the result of, a significant risk to public health in Canada and
• immediate action is required to deal with the risk

As per section 68.36 of the MDR, the Minister may add a Class II, III or IV medical device to column 2 of the expanded use list and an expanded use to column 3. The Minister may do so if the Minister:

• has reasonable grounds to believe there is an urgent public health need for the expanded use of the device for the medical condition set out in column 1
• 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 3 of the expanded use list of a:

• licensed medical device in column 2 or
• Class II, III or IV medical device in column 2 that is the subject of a Part 1.1 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 4.

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

Request for information

The Minister may request information on 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 reviewing applications

For UPHN medical devices, Health Canada will strive to prioritize the review of:

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

Amendment applications of authorized devices that are no longer UPHN medical devices 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 devices: 15 calendar days from when the application is submitted

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 to be 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 devices: 25 calendar days from screening acceptance of a complete application
• Class III and IV devices: 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 service standards set out on this page. 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 about the Minister's intention 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 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

In general, any person who imports or sells any device (including a 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 medical device under Part 1.1 of the MDR is exempt from requiring an MDEL to import or sell that medical device. This exemption stands as long as the medical device is a UPHN medical device.

For a detailed explanation of who needs to hold an MDEL and more information on how to submit an MDEL application, 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 medical device that is imported into Canada must include a copy of the authorization. This document will:

• be issued to the applicant upon authorization
• facilitate transport of the 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 an authorized medical device should be allowed into Canada.

Advertising

Health Canada allows the advertisement of all authorized medical devices for the purpose of sale. For Class I devices, section 68.031 of the MDR permits this activity. For Class II to IV devices, section 27 of the MDR permits this activity.

If the device has been subject to a change requiring an amendment, the manufacturer must either:

• hold an amended authorization or
• only place the advertisement in a catalogue with a warning that the device advertised may not have been authorized in accordance with Canadian law

For more information on medical device advertising requirements, refer to the Advertising requirements for drugs and medical devices web page.