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Draft Health Canada IMDRF table of contents for medical device applications guidance - Canada.ca
Apr 19, 2025
legacy-hc-2025-04-21
ID 196573
Later capture
Health Canada IMDRF table of contents for medical device applications guidance - Canada.ca
Jan 2, 2026
hc-20260101
ID 428986
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updated2 sections changed; 22 added; 39 removed (high-noise change)
2 sections changed22 added39 removed+90 / -281 linesChange ratio: 77%
--- +++ @@ -1,339 +1,165 @@-Draft Health Canada IMDRF table of contents for medical device applications guidance-(-PDF version-, 650 KB, 15 pages)+Health Canada IMDRF table of contents for medical device applications guidance+Download in PDF format+(551 KB, 13 pages)+Organization:+Health Canada+Date published:+2025-11-25 On this page-1. Introduction and background-1.1 Purpose-1.2 Scope and application-1.2.1 Structure guidance-1.2.2 Content guidance-1.2.3 Assembly and system requirements guidance-1.3 Policy objectives-1.4 Policy statements-1.5 Abbreviations and acronyms-1.6 Definitions-2. Guidance for implementation-2.1 IMDRF ToC folder structure-2.2 Heading classifications and content guidance-2.2.1 Class 3 & 4-2.2.2 Class 2/private label/fax-backs (minor changes)-2.2.3 Responses to additional information or screening deficiency letters-2.2.4 Combination products-2.2.5 Market health products directorate (MHPD) post-market responses-2.3 How-to and system requirements-3. Filing process-3.1 Transmission options-3.1.1 Physical media-3.1.2 Email-3.2 Where to submit-3.2.1 Licence application and section 36 and 39 responses-3.2.2 Responses to requests from MHPD-4. Resources, tools and classification matrices-4.1 Resources-4.2 Tools-4.3 Classification matrices-5. Access to information-6. Contact information-1. Introduction and background-1.1 Purpose-The International Medical Device Regulators Forum (IMDRF) is a voluntary group of regulators committed to the acceleration of medical device regulatory harmonization and convergence. It was founded in 2011 and is the successor to the Global Harmonization Task Force. The Table of Contents (ToC) format was developed by the IMFDR to provide a globally harmonized structure and has been adopted by Health Canada for medical device regulatory activities. Health Canada is adopting the IMDRF ToC formats to encourage and support the global convergence of format for medical device applications. It is expected that use of the ToC will reduce time and costs for both industry and the regulator, and will ultimately result in timely access to medical devices for Canadians.-This guidance incorporates content from the IMDRF ToC Documents (In Vitro Diagnostic Medical Device Market Authorization Table of Contents (IVD MA ToC) and Non-In Vitro Diagnostic Device Market Authorization Table of Contents (nIVD MA ToC)) published by IMDRF and regional guidance specific to the Canadian context.-The guidance is intended to support manufacturers and regulatory correspondents in the creation of an information package for submission to Health Canada in support of medical device regulatory activities.-1.2 Scope and application-This guidance is intended to aid manufacturers and regulatory correspondents in understanding the structure, content, and assembly and system requirements for various Health Canada medical device regulatory activities.-1.2.1 Structure guidance+Introduction and background+Guidance for implementation+Filing process+Resources, tools and classification matrices+Access to information+Note about guidance documents in general+Contact information+Introduction and background+Purpose and scope+The International Medical Device Regulators Forum (IMDRF) is a voluntary group of regulators committed to the acceleration of medical device regulatory harmonization and convergence. The Table of Contents (ToC) format was developed by the IMDRF to provide a globally harmonized structure and has been adopted by Health Canada for medical device regulatory activities. Health Canada is adopting the IMDRF ToC format to encourage and support the global convergence of medical device applications. We expect that use of the ToC will reduce time and costs for both industry and the regulator, and will ultimately result in timely access to medical devices for Canadians.+This guidance incorporates content from the+In Vitro Diagnostic Medical Device Regulatory Submission Table of Contents (IVD ToC)+and+Non-In Vitro Diagnostic Device Regulatory Submission Table of Contents (nIVD ToC)+published by IMDRF and regional guidance specific to Canadian submissions.+The guidance supports manufacturers and regulatory correspondents in preparing ToC-based medical device submissions to Health Canada. It outlines:+content requirements+system and technical specifications, including:+file format+file naming conventions+path length limitations+submission media filesystem compatibility+Detailed instructions for assembling a ToC-compliant regulatory package can be found in the+Health Canada adapted assembly and technical guide for IMDRF table of contents submissions+. The ToC structure requirements apply to information packages created in support of the following: Pre-Market:-New and Amendment Class 2, Class 3 and Class 4 medical device licence applications for In-Vitro Diagnostic Devices (IVD) and Non-In Vitro Diagnostic Device (nIVD)-All medical device Private Label licence applications-All Fax-back (Minor Change) applications-All Screening Deficiency Responses, Clarification Responses, and Additional Information Responses associated with those activities listed above+New and amendment Class II, Class III and Class IV medical device licence applications for in-vitro diagnostic devices (IVD) and non-in vitro diagnostic devices (nIVD)+All medical device private label licence applications+All fax-back (minor change) applications+All screening deficiency responses, clarification responses, and additional information responses associated with those submissions listed above Post-Market:-Responses to Class 2, Class 3 and Class 4 post-market requests issued under the-Medical Devices Regulations-(e.g. Responses to Section 39 or Section 36 of the+Responses to all Classes (I to IV) post-market requests (for example, responses to Section 36 or Section 39 of the Medical Devices Regulations )-Responses to all Classes (1 to 4) for IVD and nIVD Post-Market Request from the Marketed Health Products Directorate-All Clarification and Additional Information Responses associated with those activities listed above-1.2.2 Content guidance-This guidance defines the content requirements applicable to applications for medical device licences and the other regulatory transactions and activities described in Section 1.2.1 Structure Guidance above. For additional information on the legal requirements to support medical device licence application, please refer to the-Medical Devices Regulations-.-1.2.3 Assembly and system requirements guidance-This guidance is intended to define the system requirements for all ToC submissions, focusing primarily on file format, file name, path length, and submission media filesystem concerns. This guidance also provides instructions for assembling a ToC-compliant information package.-1.3 Policy objectives-This guidance document is intended to facilitate the creation and submission to Health Canada of ToC-based medical device regulatory information.-1.4 Policy statements-This guidance is to be used in the preparation of medical device related regulatory transactions.-1.5 Abbreviations and acronyms+Abbreviations and acronyms HPFB-Health Products & Food Branch+Health Products and Food Branch IMDRF International Medical Device Regulators Forum IVD In vitro diagnostic-MHPD-Marketed Heath Products Directorate nIVD-non-in vitro diagnostic+Non-in vitro diagnostic PIS Proprietary Information Submission RPS Regulated Product Submission ToC Table of Contents-TPD-Therapeutic Products Directorate-1.6 Definitions-Summary-A summary should include a brief synopsis of the (1) purpose, (2) methods, (3) acceptance criteria, (4) results and (5) discussion and conclusions. Outliers and deviations should be reported with the results. Results should be stated quantitatively with appropriate statistical context where applicable (e.g. value ± SD, confidence intervals, etc.).+MDD+Medical Devices Directorate+Definitions+The definitions in this section explain the scientific and regulatory terms used throughout the Table of Contents guidance documents. They are very important to review before preparing a medical device submission.+Summary (IMDRF N9/N13)+A summary should include a brief synopsis of the:+(1) purpose+(2) methods+(3) acceptance criteria+(4) results+(5) discussion and conclusions+Outliers and deviations should be reported with the results. Results should be stated quantitatively with appropriate statistical context where applicable (for example, value ± SD, confidence intervals, etc.). The summary should specifically address:-Why the characteristic being evaluated is of interest;-Why the particular methods are being used to evaluate the characteristic, if applicable including why a regional or harmonized/recognized standard/guidance has or has not been complied with;-How the stated acceptance and sample size are scientifically supported;-What device was tested and how it relates to the devices that will be marketed;-Why the tested components are representative of the range of devices that will be marketed;-Whether the summary has been previously submitted and reviewed by the regulator, including identification of the device and the reference number for the submission; and-Whether the testing has been conducted in-house or by a 3rd party.-Full report-Typically includes a complete, detailed description of the objective of the assessment, the methods and procedures, study endpoint(s), pre-defined pass/fail criteria, deviations, results, discussion and conclusions, and may include data. Complete, detailed support of method selection, worst case justification, study endpoint selection, and pass/fail criteria should be included.-In vitro diagnostic device (IVDD)+Why the characteristic being evaluated is of interest+Why the particular methods are being used to evaluate the characteristic, if applicable including why a regional or harmonized/recognized standard/guidance has or has not been complied with+How the stated acceptance and sample size are scientifically supported+What device was tested and how it relates to the devices that will be marketed+Why the tested components are representative of the range of devices that will be marketed+Whether the summary has been previously submitted and reviewed by the regulator, including identification of the device and the reference number for the submission+The extent to which the duties and functions of a study (for example, testing, monitoring, etc.) have been conducted by an external organization (for example, contract research organisation or individual contractor)+Full report (IMDRF N9/N13)+Typically includes a complete, detailed description of the objective of the assessment, the methods and procedures including when applicable why a regional or harmonized/recognized standard/guidance has or has not been complied with, study endpoint(s), pre-defined pass/fail criteria, deviations, results, discussion and conclusions, and may include data. Complete, detailed support of method selection, worst case justification, study endpoint selection, and pass/fail criteria should be included.+In vitro diagnostic device (IVDD) (Medical Devices Regulations) An in vitro-Diagnostic Device is a medical device that is intended to be used in vitro for the examination of specimens taken from the body.-Manufacturer+diagnostic device is a medical device that is intended to be used in vitro for the examination of specimens taken from the body.+Manufacturer (Medical Devices Regulations) A Manufacturer is a person who sells a medical device under their own name, or under a trade-mark, design, trade name or other name or mark owned or controlled by the person, and who is responsible for designing, manufacturing, assembling, processing, labelling, packaging, refurbishing or modifying the device, or for assigning to it a purpose, whether those tasks are performed by that person or on their behalf. Proprietary information submissions-Proprietary Information Submissions are used when firms that manufacture or process the device under contract to the manufacturer elect to submit all or a portion of the manufacturing information applicable to their facility directly to the Medical Device Bureau (MDB) in the form of a Proprietary Information Submission. The manufacturer or device sponsor should inform these firms of the need to provide detailed information on the device. Manufacturers referencing information held in a Proprietary Information Submission submitted by another company must obtain permission from the owner of the file each time the file is accessed. The letter of permission should indicate the extent of information to be considered for each application.-Recall-A recall in respect of a medical device that has been sold, means any action taken by the manufacturer, importer or distributor of the device to recall or correct the device, or to notify its owners and users of its defectiveness or potential defectiveness, after becoming aware that the device:-may be hazardous to health;-may fail to conform to any claim made by the manufacturer or importer relating to its effectiveness, benefits, performance characteristics or safety; or,+Proprietary Information Submissions are used when firms that manufacture or process the device under contract to the manufacturer elect to submit all or a portion of the manufacturing information applicable to their facility directly to the Medical Devices Directorate (MDD) in the form of a Proprietary Information Submission. The manufacturer or device sponsor should inform these firms of the need to provide detailed information on the device. Manufacturers referencing information held in a Proprietary Information Submission submitted by another company must obtain permission from the owner of the file each time the file is accessed. The letter of permission should indicate the extent of information to be considered for each application.+Recall (Medical Devices Regulations)+A recall is:+A recall ordered by the minister under section 21.3 of the Food and Drugs Act, or+Any action taken by the manufacturer, importer or distributor of a medical device, after the device has been sold, to recall or correct the device, or to notify its owners and users of its defectiveness or potential defectiveness, after becoming aware that the device+may present a risk of injury to health+may fail to conform to any claim made by the manufacturer or importer relating to its effectiveness, benefits, performance characteristics or safety, or may not meet the requirements of the Food and Drugs Act or the Medical Devices Regulations-.-2. Guidance for implementation-2.1 IMDRF ToC folder structure-The IMDRF ToC structure is defined by IMDRF. The headings are to be structured in a folder structure mimicking the hierarchy described. In order to reduce the file path lengths, names have been shortened in some cases. Further discussion and details regarding the folder structure is included in the-Health Canada Adapted Assembly and Technical Guide.-Folder structure templates are available and must be followed; see-Section 4 - Resources, Tools, and Classification Matrices-below for further details.-2.2 Heading classifications and content guidance-As the IMDRF ToC is comprehensive in nature, not all headings are required for Health Canada. The ToC documents are therefore intended to work together with a separate document created for each participating jurisdiction – a Classification Matrix. Headings that are required are defined in the Health Canada classification matrices and depend on the submission type.-Heading classifications are used to define content requirements for various different application types in the documentation that follows. Complete definitions and discussion of heading classifications is provided in the-Health Canada Adapted Assembly and Technical Guide-and familiarization is strongly recommended. For convenience, brief definitions are provided below:-R - Required.-Any folder that is established as Required must not be deleted. Content must be submitted in this folder.-NR - Not Required.-Any folder that is established as Not Required must be deleted.-CR - Conditionally Required.-Any folder that is established as Conditionally Required needs a determination against the conditions by the applicant. Specific conditions are defined by Health Canada for each CR heading and can be found in the detailed content guidance.-O - Optional.-Any folder that is established as Optional requires a decision by the applicant and then must be deleted if not populated.-OR - Optional but Recommended.-Any folder that is established as Optional but Recommended requires a decision by the applicant and then must be deleted if not populated.-2.2.1 Class 3 and 4-Guidance regarding the content of an application is presented based on the content requirement defined by IMDRF as well as any additional regional guidance. This guidance has been arranged by type of device application as follows:-Class 3 nIVD Applications Content and Classification Guidance-Class 4 nIVD Applications Content and Classification Guidance-Class 3 IVD Applications Content and Classification Guidance-Class 4 IVD Applications Content and Classification Guidance+Guidance for implementation+Guidance on application content is based on the requirements set out in the IMDRF ToC as well as Health Canada-specific guidance where applicable.+The IMDRF ToC structure and content guidance documents were developed primarily for medical device submissions that require pre-market safety and effectiveness data review (such as Health Canada Class III and Class IV licence applications). Other submission transaction types (such as Class II, post-market, fax-back (minor change), private labels) typically require a more limited subset of IMDRF ToC headings.+The requirements for these various submission types are discussed in the sections below.+Class III and IV+Class III and IV applications require a comprehensive pre-market review. Submissions follow the ToC folder structure and reflect both IMDRF requirements and Health Canada-specific expectations. For detailed content guidance and conditions refer to the following:+Class III nIVD applications content and classification guidance+Class IV nIVD applications content and classification guidance+Class III IVD applications content and classification guidance+Class IV IVD applications content and classification guidance+Class II, private label, fax-backs (minor change)+Class II, private label, and fax-back (minor change) applications have significantly different evidentiary requirements from Class III and IV applications. While the ToC is used for these, only select folders are required and content guidance is specific to this context.+For detailed content guidance and conditions refer to the following:+Class II application content and classifications guidance+Private label application content and classification guidance+Fax-back (minor change) application content and classification guidance+Responses to additional information or screening deficiency letters+Responses to requests from Health Canada must clearly identify the application number of the associated application. Responses to screening deficiency letters, clarification requests, and additional information letters must be provided in a question and answer format and be accompanied by a copy of the original Health Canada letter. This information is to be filed within Section “1.01-Cover Letter” and the substantial supporting information must be structured using the same format as the initial application. Note:-Heading numbers that are not required by Health Canada are excluded from the content guidance and templates (e.g. 1.01 - Cover Letter is followed by 1.03 - List of Terms/Acronyms as 1.02 - Submission Table of Contents is not required by Health Canada).-Chapter 3 (Non-clinical evidence) incorporates Overview folders and Custom headings. Overview folders have been created in the folder template where the IMDRF ToC guidance indicates a requirement for content at a parent folder. This folder structure was created to ensure the sequence of information presented is maintained in a Windows environment. For example, in the nIVD structure, Section 3.05.06 Biocompatibility & Toxicology Evaluation, there is a sub-folder named “3.05.06.00-Overview” in the template. The content prescribed by the IMDRF guidance for Section 3.05.06-Biocompatibility & Toxicology Evaluation should be placed in this folder. Each specific study/piece of evidence should have its own Custom heading. Within each custom heading are a summary and, when required, full report files. Guidance for each of these folders/headings should be strictly followed. Further details are provided in the Health Canada Adapted Assembly and Technical Guide.-When presenting a summary for sections in Chapter 3, you should follow the detailed definitions of a summary as described in Section 1.6-Definitions above.-Do not repeat identical content in multiple sections of your submission.-The IMDRF ToC structure and content guidance were developed primarily for Class 3 and Class 4 medical device licence applications. Other transaction types (i.e. Class II, Post-Market, Fax-back (Minor Change), Private Labels) typically require a very limited subset of IMDRF ToC headings and the requirements for these submissions types are discussed within this document in Sections 2.2.2 and 2.2.4 below.-2.2.2 Class 2, private label, fax-backs (minor change)-Class 2, Private label, and Fax-backs (minor change) have significantly different evidentiary requirements from Class 3 and 4 applications. While the ToC is used for these, only select folders are required and content guidance is specific to this context.-Note:-No distinction is made between nIVD and IVD for applications of these types.-A sample folder structure for Class 2/Private Label/Fax-backs (Minor Change) applications is shown below:-Figure 1 - Screenshot depicting the folder structure for Class 2/Private Label/Fax-backs (Minor Change) applications-Text Description-The root folder is “Licence Name” and sub-folders includes 1-REG ADMIN, 2-CONTEXT, 5-LABELLING sub folders that are applicable as defined in the table below-The classifications for the headings within Class 2/Private Label/Fax-back (Minor Change) applications are shown in the table below.-Note:-Classifications are defined in Section 2.0.-Table 1 – Classifications for various Class 2, private label and fax-back (minor change) applications-Folder-Licence-Private Label-Fax-Back (Minor Change)-Class 2-Class 2, 3, 4-Class 3/4-All Classes (except addition to Class 3/4)-All Classes-New-Amend-New & Amend-Add New Device Identifier-Add, Delete or Change Device Identifier-Change to Licence/ Device Name-Change to Manufacturer’s Name/ Address-1.01-CR-CR-CR-CR-CR-CR-CR-1.04-R-R-R-R-R-R-R-1.06-R-NR-NR-NR-NR-NR-R-1.09-CR-CR-CR-CR-CR-CR-CR-1.14-NR-NR-R-R-R-R-R-2.04.04-NR-O-NR-R-NR-NR-NR-5.02-CR-CR-CR-O-O-O-O-5.03-CR-CR-CR-O-O-O-O-5.04-CR-CR-CR-O-O-O-O-5.05-CR-CR-CR-O-O-O-O-5.06-CR-CR-CR-O-O-O-O-5.07-CR-CR-CR-O-O-O-O-5.08-CR-CR-CR-O-O-O-O-5.09-CR-CR-CR-O-O-O-O-5.10-CR-CR-CR-O-O-O-O-For detailed content guidance and conditions refer to the following:-Class 2 Licence Application Content and Classifications Guidance-Private Label Application Content and Classification Guidance-Fax-back (Minor Change) Application Content and Classification Guidance-2.2.3 Responses to additional information or screening deficiency letters-Responses to requests from Health Canada must clearly identify the Application Number of the associated application. Responses to Screening Deficiency Letters, Clarification Requests, and Additional Information Letters must be provided in a question and answer format and be accompanied by a copy of the original Health Canada letter. This information is to be filed within Section “1.01-Cover Letter” and the substantial supporting information must be structured using the same format as the initial application.-Note:-Your Additional Information response should not contain information that was previously submitted within the same application. Only submit any documents that have been modified and place them in the appropriate folders with a clear reference to the changes outlined in the cover letter.-2.2.4 Combination products+Your additional information response should not contain information that was previously submitted within the same application. Only submit documents that have been modified and place them in the appropriate folders with a clear reference to the changes outlined in the cover letter.Diff output was truncated for readability.
