Class III nIVD applications content and classification guidance: Submission context

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.

On this page

• Chapter 2: Submission context
  • 2.02 General summary of submission
  • 2.04 Device description
  • 2.05 Indications for use and/or intended use and contraindications
  • 2.06 Global market history
  • 2.07 Post-market study plans
  • 2.10 Standards
  • 2.11 Other submission context information

Chapter 2: Submission context

Folder name: 2-CONTEXT

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

2.02 General summary of submission

Folder name: 2.02-GeneralSummaryofSubmission

IMDRF common content

1. Statement of the device type (for example, hip implant, infusion pump, standalone software) and name (for example, trade name, proprietary name), its general purpose, and a high-level summary of key supporting evidence (that is, studies that are unique to the risks of this device type, for example burst testing of a ceramic femoral head; electrical safety evaluation (IEC 60601) testing for an infusion pump)
2. Summary of submission, including
   1. the type of submission (for example, new, amendment, change of existing application, renewal)
   2. if amendment/supplement, the reason of the amendment/supplement
   3. if a change to existing approval, description of the change requested (for example, changes in design, performance, indications, changes to manufacturing processes, manufacturing facilities, suppliers);
   4. any high-level background information or unusual details that the manufacturer wishes to highlight in relation to the device, its history or relation to other approved devices or previous submissions (provides context to submission)

IMDRF Health Canada content

If amendment or new submission based on currently licenced device(s), the Canadian medical device licence number(s) should be provided along with the description of the change requested. 

If amendment, there may be multiple sections where there is “no change”.  These folders would thus be considered “not applicable”.  A list of these sections may be provided here, identified as “no change” and then the appropriate folders would be excluded from the submission.

If amendment or new submission, if a report can fit into multiple sections, only one copy should be included and references to the single copy provided in other sections where the information might be applicable.

If requesting priority review per Section 15 of the application form, the justification should be provided here.

Classification

New and amendment applications: Required

2.04 Device description

Folder name: 2.04-DeviceDescription

No content at this level.

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

Classification

New and amendment applications: Required

2.04.01 Comprehensive device description and principle of operation

Folder name: 2.04.01-ComprehensiveDeviceDesc-PrincipleofOp

IMDRF common content

1. A general description of the device, including:
   1. A statement of the device name
   2. What the device does
   3. Who uses it and for what (high level statement)
   4. Where to use it (places/environment where the device is intended to be used)
   5. How it works. Including a description of the features/variants/operating modes that enable the device to be used for indications/intended use (principle of operation/mechanism of action) and if not readily apparent or typical for the device type, a brief description of the underlying science/technology, design concepts, and/or theoretical principles supporting the device's function
   6. If applicable, labelled pictorial representation (diagrams, photos, drawings).
   7. If system, how the components relate
   8. If applicable, identify if the device incorporates software/firmware and its role
2. Product specification, including:
   1. Physical characteristics or relevance to the end user (dimensions, weight)
   2. Features and operating modes
   3. Input specifications (for example, electrical power requirements, settings and associated allowable ranges/limits)
   4. Output and performance characteristics (for example, range and type of energy delivered, resolution of images)
   5. If applicable, an indication of the variants/models of the devices and a summary of the differences in specifications of the variants (comparison table and/or pictures/diagrams with supporting text).
3. List of accessories intended to be used in combination with the devices
4. Indication of any other medical devices or general product intended to be used in combination with the medical device (for example, infusion sets and infusion pumps, bipolar electrode and RF equipment)
5. Components or accessories that can be sold separately should be identified
6. If approved by the regulator, provide the approval number and identification for each component or accessory
7. If the device is to be sterilized, an indication of who is to perform the sterilization and by what method (for example, EtO, gamma irradiation, dry heat) or an affirmative statement that the device is non-sterile when used
   • Note: The validation report is not expected be presented at this point, only the device sterility condition shall be indicated here. If appropriate, for the validation report, see Chapter 3: Non-clinical studies
8. Summary of the composition of the device including, at minimum, the material specification and/or chemical composition of the materials that have direct or indirect contact with the user and/or patient. When required, full details to support how these specifications are met are to be provided in 3.5.02 –Chemical/Material Characterization
   • Note: If applicable, chemicals may be identified using either the IUPAC (International Union of Pure and Applied Chemistry) or the CAS (Chemical Abstract Service) Registry number. Reference to applicable material standards may also be useful in this description
9. If applicable, indication of biological material or derivate used in the medical device, including:
   1. origin (human, animal, recombinant or fermentation products or any other biological material)
   2. source (for example, blood, bone, heart, any other tissue or cells)
   3. the intended reason for its presence and, if applicable, its primary mode of action.
10. If the device contains an active pharmaceutical ingredient (API) or drug, an indication of the substance, should be provided. This should include its identity and source, and the intended reason for its presence and its primary mode of action
11. Engineering diagrams/prints/schematics of the device (should be provided as a separate file within the submission)

Note: The sponsor/applicant should explicitly address any existing regional regulatory guidance related to the comprehensive device description and principles of operations provided in this section regarding the subject device

IMDRF Health Canada content

If the application is an amendment, this section should describe both the device as currently on the licence as well as the modifications proposed. Modifications (for example, changes in design, performance and indications) should be further detailed in Section 2.04.04 below.

Health Canada guidance

For devices containing an API or drug, refer to Health Canada’s policies about the classification of combination products, for example: 

• Policy on drug/medical device combination products - Decisions 
• Drug/medical device combination products

Classification

New and amendment applications: Required

2.04.02 Description of device packaging

Folder name: 2.04.02-DescriptionofDevicePackaging

IMDRF common content

1. Information regarding the packaging of the devices, including, when applicable, primary packaging, secondary and any other packaging associated
2. Specific packaging of accessories marketed together with the medical devices shall also be described
3. If the user needs to package the medical device or its accessories before they perform sterilization, information about the correct packaging (for example, material, composition, dimension) should be provided

Health Canada guidance

Describe the packaging of the device (or its components, if any), including the materials used. It should be clear what protective characteristics the packaging provides (for example, maintains sterility, humidity, light sensitivity, transportation protection).

Classification

New licence applications: Required

Amendment licence applications: Conditionally required – Required if there have been changes in the packaging since the previous submission or if the packaging is relevant to the submission (for example, there has been a change in shelf life or sterilization methods).

2.04.03 History of development

Folder name: 2.04.03-HistoryofDevelopment

IMDRF common content

For any device versions/prototypes referenced in the evidence presented in the submission, a table describing the version/name, with 4 columns (device name and/or version; description of changes from previous row; motivation for the change; list of verification/validation activities, including clinical studies, conducted using this version).

For any design verification or validation activities presented in this submission (including clinical studies) performed on any earlier versions of the subject device, include a justification for why the changes do not impact the validity of the data collected under those activities in supporting the safety and effectiveness of the final device design.

IMDRF Health Canada content

It is highly recommended that a description of all changes made to the device since the issuance of the last medical device licence or licence amendment be provided for a device that has had a previous version licensed in Canada.

Classification

New and amendment applications: Required

2.04.04 Reference and comparison to similar and/or previous generations of the device

Folder name: 2.04.04-Ref-ComparisontoSimilarand-orPreviousGen

IMDRF common content

1. A list of similar devices (available on local and international market) and/or previous generation of the devices (if existent) relevant to the submission. This should include any similar/previous generation devices that were previously reviewed and refused by the subject regulator
2. Description of why they were selected
3. A key specification comparison, preferably in a table, between the references (similar and/or previous generation) considered and the device

IMDRF Health Canada content

1. If the application is an amendment to a licenced device or is based on a modification of a licensed device, a description of the modifications is required (for example, changes in design, performance, and indications)
2. Comparisons can be used to support the safety and effectiveness of the device if they are made to a currently licensed device in Canada. If this method is used, ensure the Canadian medical device licence number of the comparator is stated. The comparison device does not need to be manufactured by the same manufacturer

Health Canada guidance

When adding a device identifier, comparative information is necessary to validate compliance with licence type requirements. Include a comparison table that outlines all differences between the devices represented by the new identifiers and a closely related licensed comparator(s).

Classification

New and amendment applications: Required

2.05 Indications for use and/or intended use and contraindications

Folder name: 2.05-Indications-IntendedUse-Contraindications

Note: No content at this level

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

Classification

New and amendment applications: Required

2.05.01 Intended use, intended purpose, intended user, indications for use

Folder name: 2.05.01-IntendedUseandIndications

IMDRF common content

This section should include, as appropriate:

1. Intended use: The statement of intended use should specify the therapeutic or diagnostic function provided by the device and may describe the medical procedure in which the device is to be used (for example, Diagnosis in vivo or in vitro, treatment monitoring rehabilitation, contraception, disinfection).
2. Intended purpose: What is expected with the use of this medical device? Which results are expected?
3. Intended user and skills/knowledge/training that the user should have to operate or use the device.
4. Identify if the device is intended for single or multiple use
5. Indications for use:
   1. Disease or medical condition that the device will diagnose, treat, prevent, mitigate, or cure, parameters to be monitored and other considerations related to indication for use
   2. If applicable, information about patient selection criteria
   3. If applicable, information about intended patient population (for example, adults, pediatrics or newborn) or a statement that no subpopulations exist for the disease or condition for which the device is intended
6. For amendments/supplements or changes to existing approvals, identify any changes to the previously approved intended use/intended purpose/intended user/indications. If there are no changes, this should be stated, and a reference should be made to the precise regional regulatory tracking number associated with the previous submission/approval

Notes:

1. The statements of intended use and purpose and the intended user and indications for use must be as presented in the labelling.
2. If more than one device is included, the information should be provided for each device.

Classification

New and amendment applications: Required

2.05.02 Intended environment, setting for use

Folder name: 2.05.02-IntendedEnvironment-Setting

IMDRF common content

1. The setting where the device is intended to be used (for example, domestic use, hospitals, medical/clinical laboratories, ambulances, medical/dental offices). Multiple options can be indicated
2. If applicable, environmental conditions that can affect the device’s safety and/or performance (for example, temperature, humidity, power, pressure, movement)

Classification

New and amendment applications: Required

2.05.04 Contraindications for use

Folder name: 2.05.04-Contraindications

IMDRF common content

If applicable, specify the disease or medical conditions that would make use of the device inadvisable due to unfavorable risk/benefit profile.

Note: The statement of contraindications for the device must be as presented in the labelling. 

Classification

New and amendment applications: Required

2.06 Global market history

Folder name: 2.06-GlobalMarketHistory

Note: No content at this level.

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

Classification

New and amendment applications: Required

2.06.01 Global market history

Folder name: 2.06.01-GlobalMarketHistory

IMDRF common content

1. Up to date identification of the markets (all countries or jurisdictions) where the device is approved for marketing
2. Should include history of the marketing of the device by any other entity, acknowledging that detailed information may not be available in all cases
3. Include a list of all countries in which the device has been removed from marketing for any reason related to the safety or effectiveness of the device

IMDRF Health Canada content

1. If the subject device is different in any way (for example, design, labelling, specifications, indications) from those approved or marketed in other jurisdiction, the differences should be described
2. The month and year of market approval in each country or jurisdiction where the device is marketed. If the device has been marketed for greater than 10 years, a statement of greater than 10 years can be made
3. For each of the markets listed in (a) above, and statement of the commercial names used in those markets or a clear statement that the commercial names are the same in all jurisdictions
4. State the date of data capture for the market history data
5. If the subject device has been the subject of any previous compassionate use and/or clinical trials this should be identified and, if applicable, relevant reference numbers provided

If there is any approval number, given to the device by the regulator authority of the markets (country or jurisdictions) where the device is already marketed, this identification must be provided.

Marketing history of a Health Canada licensed, previous version of the device can sometimes be used in support of safety or effectiveness of the subject device. If this is to be the case, then the name of the comparator, its medical device licence number and the number of units sold should be provided.

In this context, compassionate use includes any Special Access Authorizations.

Classification

New and amendment applications: Required

2.06.02 Incident reports and recalls

Folder name: 2.06.02-IncidentReports-Recalls

IMDRF common content

1. List adverse events/incidents associated with the device and a statement of the period associated with this data
2. If the number of adverse events is voluminous, provide a summary by event type that state the number of reported events for each event type
3. List of the medical device recalls and/or advisory notice, and a discussion of the handling and solution given by the manufacturer in each case
4. A description of any analysis and/or corrective actions undertaken in response to items listed above
5. If there have been no adverse events/incidents, recalls and/or advisory notice to date, provide an attestation from device owner on company letterhead, that there have been no adverse events/incidents, recalls and/or advisory notice since commercial introduction of the device

Notes:

1. It is acknowledged that the definition of recall may vary from one jurisdiction to another.

IMDRF Health Canada content

1. The jurisdiction(s) associated with the incident should be clearly indicated.
2. Incidents should include any Canadian incidents through SAP or other previous Canadian applications, if known.
3. If marketing history is presented for a previously licensed device, then the associated recalls, and incident reports for that device should also be summarized here.

Classification

New and amendment applications: Required

2.06.03 Sales, incident and recall rates

Folder name: 2.06.03-SalesIncident-RecallRates

IMDRF common content

1. A summary of the number of units sold in each country/region and a statement of the period associated with this data
2. Provide the rates calculated for each country/region, for example:
   1. Incident rate = # adverse events/incidents divided by # units sold, expressed as a percentage
   2. Recall rate = # recalls divided by # units sold, expressed as a percentage

Rates may be presented in other appropriate units such as per patient year of use or per use. In this case, methods for determining these rates should be presented and any assumptions supported.

3. Critical analyses of the rates calculated (for example, Why are they acceptable? How do they break down in terms of incidents? Is there some outlier data that has driven the rates up? Are there any trends associated with any sub-groups of the devices that are subject of the submission (for example, size, version)?).

Notes:

1. It is acknowledged that the definition of recall may vary from one jurisdiction to another.
2. Sales in this context should be reported as the number of units sold.
3. The summary of sales should be broken down by components when appropriate.

Classification

New and amendment applications: Required

2.07 Post-market study plans

Folder name: 2.07-Post-MarketStudyPlans

IMDRF common content

Post-market study plans may include clinical or nonclinical study plans. The documentation provided here will not include final reports and analysis, and instead includes study plan information only. This may include:

1. Study objectives
2. Study design
3. Subjects and sites information
4. Endpoints (primary and secondary)
5. Summary of data analysis plan
6. Length and frequency of follow-up

Note: Post-market non-clinical or clinical data from one region provided during the pre-market phase to a second region would be considered non-clinical or clinical data for the second region and would reside in Chapter 3 or Chapter 4, respectively.

Classification

New and amendment applications: Optional

2.10 Standards

Folder name: 2.10-Standards

IMDRF common content

No content at this level.

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

Classification

New and amendment applications: Conditionally required – If any sub-headings are required

2.10.01 List of standards and guidance documents

Folder name: 2.10.01-ListofStandards

IMDRF common content

This section should include:

1. If applicable, a list of the standards that have been complied with in full or in part in the design and/or manufacture of the device
   1. At a minimum should include the standard organization, standard number, standard title, year/version, and if full or partial compliance
   2. If partial compliance, a list of the sections of the standard that:
      • are not applicable to the device, and/or
      • have been adapted, and/or
      • were deviated from for other reasons – discussion to accompany
2. If applicable, a list of relevant guidance documents published by regulators and referenced in the design and/or manufacture of the device with the jurisdiction of publication, publication date and title identified
3. If applicable, a list of relevant clinical guidelines referenced in the design and/or manufacture of the device, the publisher, publication date and title identified

Classification

New licence applications: Conditionally required – If demonstrating that device complies with standards

Amendment licence applications: Conditionally required – If there are standards that have been applied in relation to the amendment

2.10.02 Declaration and/or certification of conformity

Folder name: 2.10.02-Declarationand-orCertificationofConformity

IMDRF Health Canada content

The applicant is advised to prepare the Declaration of Conformity to recognized standards using Health Canada's Declaration of Conformity form. Refer to the guidance on using standards to support compliance with the Medical Devices Regulations and the current list of recognized standards for medical devices.

Classification

New licence applications: Conditionally required – If demonstrating that device complies with standards

Amendment licence applications: Conditionally required – If declaration of conformity is being made relating to standards relevant to the amendment

2.11 Other submission context information

Folder name: 2.11-OtherSubmissionContextInformation

IMDRF common content

Heading for other submission context 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 in any of the other headings of this chapter.