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Class IV IVD applications content and classification guidance: Regional administrative

IMDRF common content and IMDRF Health Canada content may contain minor formatting or editorial edits compared to the source material. These changes were made to conform with the Government of Canada’s guidelines for web content.

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Chapter 1: Regional administrative

Folder name: 1-REGADMIN

Note: No files or content should be included at this level. Only sub-folders of this folder should contain documents.

1.01 Cover letter

Folder name: 1.01-CoverLetter

IMDRF common content

  1. The cover letter should state applicant or sponsor name and/or their authorized representative/s, the type of submission, the common name of the device (if applicable), device trade name or proprietary name (both of the base device and a new name if one is given to the new version/model of the device) and include the purpose of the application, including any changes being made to existing approvals
  2. If applicable and accepted by the regulator, it should include information pertaining to any master files referenced by the submission
  3. If applicable, acknowledgement that a device sample has been submitted or offered alternatives to allow the regulator to view or access the device (when the regulator requests a sample)
  4. If the submission is requesting approval of a change that is the result of CAPA due to a recall, this should be stated
  5. If the submission is in response to a request for information from the regulator this should be stated and the date of that letter should be included as well as any reference number(s)
  6. If the submission is unsolicited information (where accepted), this should be stated and any related reference number(s) provided
  7. Identification of the regulatory jurisdiction(s) in which marketing is sought

Note: The cover letter should not contain any detailed scientific information.

Health Canada guidance

Any information submitted to Health Canada should be accompanied by a cover letter. The cover letter should include the purpose of the application and a brief description of the package being submitted. It may also include proprietary information pertaining to the submission. The Table of Contents (ToC) structure requirements also apply to information packages created in support of all Screening Deficiency Responses, Clarification Responses, and Additional Information Responses. Summaries and full reports, when applicable, should be provided in a ToC-compliant package. 

Classification

New and amendment applications: Required

1.03 Terms and acronyms

Folder name: 1.03-ListofTerms-Acronyms

IMDRF common content

Terms or acronyms used in the submission that require definition, should be defined here.

Classification

New and amendment applications: Required

1.04 Application form, administrative information

Folder name: 1.04-ApplicationForm-AdministrativeInfo

IMDRF Health Canada content

Health Canada application forms should be included here.

Health Canada guidance

Obtain the appropriate Class II, III, or IV medical device licence application form. For more information on how to complete the application form for a medical device licence, consult:

For applications submitted through the Regulatory Enrolment Process (REP), the Class II, III, or IV medical device licence application forms are not required. Instead, applicants must complete the Regulatory Transaction (RT) template and, if applicable, the Application Information (AI) template, which generate the required REP Extensible Markup Language (XML) files. These XML files replace the standard application forms and must be included in the regulatory transaction. Do not submit the standard application forms, as the information is already captured within the XML files. For more information, consult:

Classification

New and amendment applications: Required

1.05 Listing of devices

Folder name: 1.05-ListingofDevice(s)

IMDRF common content

A table listing each variant/model/configuration/component/accessory that is the subject of the submission and the following information for each:

  1. the identifier (for example bar code, catalogue, model or part number, UDI)
  2. a statement of its name/description (for example Trade name, size, intended use)

Notes:

  1. A model/variant/configuration/component/accessory of a device has common specifications, performance and composition, within limits set by the applicant.
  2. Typically each item listed should be available for sale. For example, if everything is sold as part of a kit, then this list would only include the kit. You do not need to list all components that may be sold within a kit/set, unless the component is available for sale independently of the kit.

Health Canada guidance

The listing of devices is part of the medical device licence application form. A separate file in this folder is not required for submissions sent on physical media or by email until REP becomes mandatory. Once REP becomes mandatory, all Medical Device Licence (MDL) submissions must be submitted electronically via the Common Electronic Submission Gateway (CESG). At that time, submissions via physical media or email will no longer be accepted.

For applications that are submitted through the REP, applicants should complete the Device Details spreadsheet found in the REP for medical devices page.

Please ensure that there are no additional security settings applied to submitted files. This includes password protection, restricted access, Digital Rights Management (DRM), or Information Rights Management (IRM). Files with these settings may be blocked by Health Canada’s security policies, preventing these documents from being accessed.

Classification

New applications: Conditionally required – If application is submitted through REP

Amendment applications: Conditionally required – If application impacts the manufacturer’s device identifier listing and is submitted through REP

1.06 Quality management system, full quality system, other regulatory certificates

Folder name: 1.06-QMSFullQSorOtherRegulatoryCerts

IMDRF Health Canada content

Health Canada will only accept MDSAP certificates that have been issued by recognized auditing organizations.

Classification

New licence applications: Required

Amendment licence applications: Not required

1.09 User fees

Folder name: 1.09-UserFees

IMDRF Health Canada content

Health Canada user fee forms should be included here.

Health Canada guidance

When submitting an application for a medical device licence, please refer to the Medical device application fee form for detailed instructions. They must be carefully followed to avoid delays in the processing of your application. Guidance on fees for the review of medical device licence applications can be found in the Guidance Document: Fees for the Review of Medical Device Licence Applications .

Classification

New and amendment applications: Required

1.10 Pre-submission correspondence, previous regulator interactions

Folder name: 1.10-Pre-SubmissionCorrespondence-PreviousRegulatorInteractions

IMDRF common content

  1. During the product lifecycle, pre-submission correspondence, including teleconferences or meetings, may be held between the regulator and the applicant.  Further, the specific subject device may have been subject to previous regulatory submissions to the regulator. The contents should be limited to the subject device as similar devices are addressed in other areas of the submission.  If applicable, the following elements should be provided:
    1. List prior submissions or pre-submissions where regulator feedback was provided
    2. For previous regulatory submission, include identification of applicable submission reference number
    3. For any pre-submission activities that have not previously been assigned any tracking/reference number, include the information package that is submitted prior to pre-submission meetings, the meeting agenda, any presentation slides, final meeting minutes, responses to any action items arising from the meetings, and any email correspondence related to specific aspects of the application
    4. Issues identified by the regulator in prior submissions (that is, clinical study applications, withdrawn/deleted/denied regulatory submission) for the subject device
    5. Issues identified and advice provided by the regulator in pre-submission interactions between the regulator and the applicant/sponsor
    6. Explain how and where the prior advice was addressed within the submission

Or

  1. Affirmatively state there has been no prior submissions and/or pre-submission interactions for the specific device that is the subject of the current submission

Note: The scope of this section is limited to the particular regulator to which the submission is being submitted (for example Health Canada does not need pre-submission information relating to interactions with ANVISA).

Classification

New and amendment licence applications: Conditionally required – When relevant to the application

1.13 Letters of reference

Folder name: 1.13-LettersofReference

IMDRF common content

Where applicable, letter from the owner of any separate document referenced in the submission (for example Master File or previous regulatory submission), granting access to the information in the referenced document. The letter should include the information of the applicant who cited the separate document (for example Master File or previous regulatory submission), the product name, the document number that has been filed, and the page number/chapter information of the separate document authorized to be cited.

Classification

New and amendment applications: Conditionally required: When a master file is referenced

1.15 Other regional administrative information

Folder name: 1.15-OtherRegionalAdministrativeInfo

IMDRF common content

Heading for other administrative information that may be important to the submission but that does not fit in any of the other headings of this chapter.

Note: To ensure all elements of your submission are adequately reviewed, please be sure that any content placed here does not belong under any heading described above.

Classification

New and amendment applications: Conditionally required – When information is requested by the regulator (through guidance documents or other communication) but does not belong elsewhere in this chapter

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2025-11-25