Class II application content and classifications guidance: Regional administrative
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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
- The cover letter should state applicant or sponsor name and/or their authorized representative, 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
- If applicable and accepted by the regulator, it should include information pertaining to any master files referenced by the submission
- 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)
- If the submission is requesting approval of a change that is the result of CAPA due to a recall, this should be stated
- 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)
- If the submission is unsolicited information (where accepted), this should be stated and any related reference number(s) provided
- 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 information pertaining to Proprietary Information Submission. When applicable, identify the licence/application number and section associated with the submission (for example, Section 36 or Section 39 of the Medical Devices Regulations).
When responding to a Screening Deficiency Notice, applicants should provide their response in a question-and-answer format accompanied by a copy of this notice. This information is to be filed within folder 1.01 – Cover Letter.
Classification
New and amendment applications: Required
1.04 Application form and administrative information
Folder name: 1.04-ApplicationFormAdministrativeInfo
IMDRF Health Canada content
Health Canada application forms should be included here.
Health Canada guidance
Obtain the appropriate 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 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 variant/model:
- the identifier (for example, bar code, catalogue, model or part number, UDI)
- a statement of its name/description that provides (for example, Trade name, size, material)
Notes:
- A model/variant/configuration/component/accessory of a device has common specifications, performance and composition, within limits set by the applicant.
- 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.
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 or 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.
Health Canada guidance
A copy of the quality management system certificate should be included here if applicable.
Classification
New licence applications: Required
Amendment licence applications: Conditionally required – Include the quality management certificate if the amendment includes a change in the manufacturer's name.
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, include the medical device licence application fee form 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 and previous regulator interactions
Folder name: 1.10-Pre-SubmissionCorrespondence-PreviousRegulatorInteractions
IMDRF common content
- 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:
- List prior submission or pre-submissions where regulator feedback was provided
- Prior submissions should include identification of applicable submission number
- 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
- Issues identified by the regulator in prior submissions (that is, clinical study applications, withdrawn/deleted/denied regulatory submission) for the subject device
- Issues identified and advice provided by the regulator in pre-submission interactions between the regulator and the applicant/sponsor
- Explain how and where the prior advice was addressed within the submission
Or
- 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 applications: Conditionally required – If applicable