Table of contents post-market submission guidance

On this page

• Heading Classifications and Content Examples
• Tools
• Submission filing process

Heading Classifications and Content Examples

Not all folders (headings) are required for every submission. While the Table of Contents (ToC) is used for these interactions, only select folders are required for post-market submissions, and content guidance is specific to this context. A sample folder structure is shown below:

• Licence name
  • 1-REGADMIN
    • 1.01-CoverLetter
    • 1.03-ListofTerms-Acronyms
    • 1.05-ListofDevices
    • 1.10-Pre-SubmissionCorrespondence-PreviousRegulatorInteractions
  • 2-CONTEXT
    • 2.04-DeviceDescription
      • 2.04.03-HistoryofDevelopment
    • 2.06-GlobalMarketingHistory
      • 2.06.01-GlobalMarketHistory
      • 2.06.02-IncidentReports-Recalls
      • 2.06.03-SalesIncident-RecallRates
    • 2.11-OtherSubmissionContextInfo
  • 4-CLINICAL
    • 4.05-RWD
    • 4.06-Post-MarketSurveillanceData
  • 5-LABELLING
    • 5.02-Product-PackageLabels
    • 5.03-PackageInsert-InstructionsforUse
    • 5.04-e-labelling
    • 5.05-HealthcareProfessionalLabelling
    • 5.06-PatientLabelling
    • 5.07-Technical-OperatiorManual
    • 5.08-PatientFileStickers-Cards-ImplantRegistrationCards
    • 5.09-ProductBrochures
    • 5.10-OtherLabelling-PromotionalMaterial

The table below outlines the classification, applicable conditions and examples of content for each heading.

Legend

• R = Required
• CR = Conditionally Required
• O = Optional
• NR = Not Required

All Classes for IVD and non-IVD (I to IV) Post-Market Request and Additional Information Responses to Post-Market Requests

Chapter 1 – Regional Administrative

Folder name	Classification	Condition	Examples
1.01-Cover Letter	R	N/A	Cover letter or email response from manufacturer.
1.03-List of Terms/Acronyms	O	N/A	List of terms or acronyms that are used in the transaction
1.05-Listing of Device(s)	CR	Required for Class I Include when applicable or requested for Class II, III, IV	List of devices including trade or product names, catalogue or reference numbers.
1.10-Pre-Submission Correspondence and Previous Regulator Interactions	R	N/A	Post-market request letter or email.

Chapter 2 – Submission Context

Folder name	Classification	Condition	Examples
2.04-Device description	CR	If applicable to request
2.04.03-History of Development	CR	If applicable to request	Description of design changes and rationale for changes when requested/implemented.
2.06-Global Market History	CR	If applicable to request
2.06.01-Global Market History	CR	If applicable to request	Countries where device is licensed and date of licensing.
2.06.02-Incident Reports and Recalls	CR	If applicable to request	Global and Canadian complaints, incident reports and summaries, root cause analysis, investigation update / report, corrective actions, recall information.
2.06.03-Sales, Incident and Recall Rates	CR	If applicable to request	Global and Canadian incident rate (including rates in relation to sales), sales data.
2.11-Other Submission Context Information	CR	When information is requested by the regulator (through guidance documents or other communication) but does not belong in any of the other headings of this chapter.	Health Canada requested information (post market) incident issue analysis (trending analysis). A summary of individual safety and effectiveness analyses, summary reports required under specific regulatory provisions, or evaluation documents that are not otherwise captured under designated headings. Post-market device safety issue-related analysis and benefit and/or risk analysis documents. Listing or description of previous risk mitigation measures implemented or planned to address the post-market issue. For more information see Guidance on summary reports and issue-related analyses for medical devices

Chapter 4 – Clinical evidence

Folder name	Classification	Condition	Examples
4.05-Real World Data	CR	If applicable to request	Device registry, medical records data
4.06-Post-Market Surveillance Data	CR	If applicable to request

Chapter 5 – Labelling and Promotional Material

Folder name	Classification	Condition	Examples
5.02-Product/Package Labels	CR	If applicable to request	Device package label
5.03-Package Insert/Instructions for Use	CR	If applicable to request	Current instructions for use, package insert, directions for use.
5.04-e-labelling	CR	If applicable to request
5.05-Healthcare Professional Labelling	CR	If applicable to request	Physician labelling, Physician educational material.
5.06-Patient Labelling	CR	If applicable to request	Patient brochure, patient consent form, patient educational material.
5.07-Technical/Operators Manual	CR	If applicable to request	Maintenance manual
5.08-Patient File Stickers/Cards and Implant Registration Cards	CR	If applicable to request
5.09-Product Brochures	CR	If applicable to request
5.10-Other Labelling and Promotional Material	CR	If applicable to request	Any other documents that come with the device

Tools

The following additional tool is available to aid in creating post-market submissions:

• Folder Templates

Submission filing process

For filing process and transmission options, refer to the Health Canada IMDRF table of contents for medical device applications guidance page.