Class III nIVD applications content and classification guidance: Non-clinical evidence

Folder name: 3.05.01-Physical-Mechanical

IMDRF common content

Evidence that supports the physical or mechanical properties of the subject device is to be included in this section. This should include:

1. A summary of the non-clinical evidence that falls within this category
2. A discussion of the non-clinical testing considered for the device and support for their selection or omission from the verification and validation studies conducted in this category (that is, what tests were considered and why they were or were not performed)
3. If applicable, particulate testing from wear or device coatings
4. Discussion to support why the evidence presented is sufficient to support the application

Or

5. A statement of why this category of non-clinical laboratory study is not applicable to this case

Note: The sponsor/applicant should explicitly address any existing regional regulatory guidance related to the non-clinical study results provided in this section regarding the subject device.

Health Canada guidance

Applicants should include an Overview.pdf file at the parent heading level of the relevant subchapter. This document should provide a concise summary (typically 1 to 2 pages) of both the IMDRF common content and the IMDRF Health Canada content. In addition, the overview should include a brief rationale explaining how the submitted evidence supports the application.

Classification

New and amendment applications: Conditionally required – Not required when this type of evidence or testing is clearly not applicable to the device or submission. If scientific judgment is required to justify why no information is required, then the heading is considered required, and the justification should be provided.

3.05.01.01 Study description, study identifier, date of initiation

Folder name: 3.05.01.01-StudyTitle,Identifier,Date(yyyy-mm-dd)

IMDRF common content

No content at this level. This heading should be custom and based on study details and created for each study under the parent heading. The sub headings below would be for this study alone.

For example, the structure will look something like this

• Component A Fatigue Test, MT4203, 2010-10-10
  • Summary of MT4203
  • Full Report for MT4203
• Assembly B Compatibility Test, MT4584, 2011-01-23
  • Summary of MT4584
  • Full Report for MT4584

Health Canada guidance

This folder should be customized to represent the details of the study. The contents of this folder should be limited to two subfolders: the summary and full report (when required), for the study presented. As described in the Health Canada adapted assembly and technical guide for IMDRF Table of Contents submissions, these subfolders are to be named to ensure the sequence remains as described in the IMDRF ToC (summary then full report).

Further, for each additional custom folder created, the final digit of the heading number should be incremented by 1.

For example, when a fatigue test and wear test are being included, the application would include an overview file in the parent subchapter folder and two subfolders:

• a custom folder named "3.5.01.01-Component A Fatigue Test, MT4203, 2012-03-20" containing two subfolders with the appropriate files:
  • 1-Summ
    • MT4203Summ.pdf
  • 2-Report
    • MT420report.pdf
• a custom folder named "3.5.01.02-Assembly B Wear Testing, MT4584, 2012-04-12" containing:
  • 1-Summ
    • MT4584Summ.pdf
  • 2-Report
    • MT4584Report.pdf

Classification

New and amendment applications: Conditionally required: Required for each study or test presented in this section

3.05.01.01.01 Summary

Folder name: 3.05.01.01.01-Summ

IMDRF common content

A summary of the specific study described in the custom heading above.

Health Canada guidance

For detailed information on summary content requirements and expectations, refer to the Definitions section of the Health Canada IMDRF Table of Contents for medical device applications guidance.

Classification

New and amendment applications: Conditionally required – A comprehensive summary is required for each study or test presented in this section

The test summary should be sufficiently detailed to stand alone in describing the evidence.

3.05.01.01.02 Full report

Folder name: 3.05.01.01.02-Report

IMDRF common content

The test report for the test described in the custom heading above.

Health Canada guidance

For information on full report content requirements and expectations, refer to the Definitions section of the Health Canada IMDRF Table of Contents for medical device applications guidance.

Classification

New and amendment applications: Optional

Folder name: 3.05.02-Chemical-Material

IMDRF common content

Tests that describe the chemical or structural composition of the device and its components are to be included in this section. This should include:

1. A summary of the non-clinical evidence that falls within this category
2. A discussion of the non-clinical testing considered for the device and support for their selection or omission from the verification and validation studies conducted in this category (that is, what tests were considered and why they were or were not performed)
3. Discussion to support why the evidence presented is sufficient to support the application

Or

4. A statement of why this category of non-clinical laboratory study is not applicable to this case

Note: The sponsor/applicant should explicitly address any existing regional regulatory guidance related to the non-clinical study results provided in this section regarding the subject device.

Health Canada guidance

Applicants should include an Overview.pdf file at the parent heading level of the relevant subchapter. This document should provide a concise summary (typically 1 to 2 pages) of both the IMDRF common content, and the IMDRF Health Canada content. In addition, the overview must include a brief rationale explaining how the submitted evidence supports the application.

Classification

New and amendment applications: Conditionally required – Not required when this type of evidence or testing is clearly not applicable to the device or submission. If scientific judgment is required to justify why no information is required, then the heading is considered required and the justification should be provided.

3.05.02.01 Study description, study identifier, date of initiation

Folder name: 3.05.02.01-StudyTitle,Identifier,Date(yyyy-mm-dd)

IMDRF common content

No content at this level

This heading should be custom and based on study details and created for each study under the parent heading. The sub headings below would be for this study alone.

Health Canada guidance

This folder should be customized to represent the details of the study. The contents of this folder should be limited to two subfolders: the summary and full report (when required), for the study presented. As described in the Health Canada adapted assembly and technical guide for IMDRF Table of Contents submissions, these subfolders are to be named to ensure the sequence remains as described in the IMDRF ToC (summary then full report).

Further, for each additional custom folder created, the final digit of the heading number should be incremented by 1.

For example, when a fatigue test and wear test are being included, the application would include an overview file in the parent subchapter folder and two subfolders:

• a custom folder named "3.5.01.01-Component A Fatigue Test, MT4203, 2012-03-20" containing two subfolders with the appropriate files:
  • 1-Summ
    • MT4203Summ.pdf
  • 2-Report
    • MT420report.pdf
• a custom folder named "3.5.01.02-Assembly B Wear Testing, MT4584, 2012-04-12" containing:
  • 1-Summ
    • MT4584Summ.pdf
  • 2-Report
    • MT4584Report.pdf

Classification

New and amendment applications: Conditionally required – Required for each study or test presented in this section

3.05.02.01.01 Summary

Folder name: 3.05.02.01.01–Summ

IMDRF common content

This is a summary of the specific study described in the custom heading above.

Health Canada guidance

For detailed information on summary content requirements and expectations, refer to the Definitions section of the Health Canada IMDRF Table of Contents for medical device applications guidance.

Classification

New and amendment applications: Conditionally required – A comprehensive summary is required for each study or test presented in this section. The test summary should be sufficiently detailed to stand alone in describing the evidence.

3.05.02.01.02 Full report

Folder name: 3.05.02.01.02–Report

IMDRF common content

The test report for the test described in the custom heading above.

Health Canada guidance

For information on full report content requirements and expectations, refer to the Definitions section of the Health Canada IMDRF Table of Contents for medical device applications guidance.

Classification

New and amendment applications: Optional

Folder name: 3.05.03-ElectricalSystems

IMDRF common content

Evidence supporting electrical safety, mechanical and environmental protection, and electromagnetic compatibility are to be included in this section. This should include:

1. A summary of the non-clinical evidence that falls within this category
2. A discussion of the non-clinical testing considered for the device and support for their selection or omission from the verification and validation studies conducted in this category (that is, what tests were considered and why they were or were not performed)
3. Discussion to support why the evidence presented is sufficient to support the application

Or

4. A statement of why this category of study is not applicable to this case

Note: The sponsor/applicant should explicitly address any existing regional regulatory guidance related to the non-clinical study results provided in this section regarding the subject device.

Health Canada guidance

A medical device licence issued by Health Canada does not mean that the licensed device has been assessed to meet all relevant regulations. It only means that the device has been deemed to meet the requirements of the Medical Device Regulations.

The onus is on manufacturers to ensure that their devices meet all of the national or provincial regulations that apply to their product.

Applicants should also include an Overview.pdf file at the parent heading level of the relevant subchapter. This document should provide a concise summary (typically 1 to 2 pages) of both the IMDRF common content, and the IMDRF Health Canada content. In addition, the overview should include a brief rationale explaining how the submitted evidence supports the application.

Classification

New and amendment applications: Conditionally required – Not required when this type of evidence or testing is clearly not applicable to the device or submission. If scientific judgment is needed to justify why no information is required, then the heading is considered required and the justification should be provided.

3.05.03.01 Study description, study identifier, date of initiation

Folder name: 3.05.03.01-StudyTitle,Identifier,Date(yyyy-mm-dd)

IMDRF common content

No content at this level

This heading should be custom and based on study details and created for each study under the parent heading. The sub headings below would be for this study alone.

Health Canada guidance

This folder should be customized to represent the details of the study. The contents of this folder should be limited to two subfolders: the summary and full report (when required), for the study presented. As described in the Health Canada adapted assembly and technical guide for IMDRF Table of Contents submissions, these subfolders are to be named to ensure the sequence remains as described in the IMDRF ToC (summary then full report).

Further, for each additional custom folder created, the final digit of the heading number should be incremented by 1.

For example, when a fatigue test and wear test are being included, the application would include an overview file in the parent subchapter folder and two subfolders:

• a custom folder named "3.5.01.01-Component A Fatigue Test, MT4203, 2012-03-20" containing two subfolders with the appropriate files:
  • 1-Summ
    • MT4203Summ.pdf
  • 2-Report
    • MT420report.pdf
• a custom folder named "3.5.01.02-Assembly B Wear Testing, MT4584, 2012-04-12" containing:
  • 1-Summ
    • MT4584Summ.pdf
  • 2-Report
    • MT4584Report.pdf

Classification

New and amendment applications: Conditionally required – Required for each study or test presented in this section

3.05.03.01.01 Summary

Folder name: 3.05.03.01.01-Summ

IMDRF common content

This is a summary of the specific study described in the custom heading above.

Health Canada guidance

For detailed information on summary content requirements and expectations, refer to the Definitions section of the Health Canada IMDRF Table of Contents for medical device applications guidance.

Classification

New and amendment applications: Conditionally required: A comprehensive summary is required for each study or test presented in this section. The test summary should be sufficiently detailed to stand alone in describing the evidence.

3.05.03.01.02 Full report

Folder name: 3.05.03.01.02-Report

IMDRF common content

The test report for the test described in the custom heading above.

Health Canada guidance

For information on full report content requirements and expectations, refer to the Definitions section of the Health Canada IMDRF Table of Contents for medical device applications guidance.

Classification

New and amendment applications: Optional

Folder name: 3.05.04-RadiationSafety

IMDRF common content

Studies supporting radiation safety, where the device emits ionizing and/or non-ionizing radiation or where the device is exposed to radiation are to be included in this section. This includes bench tests ensuring safety and performance to support the MRI safety labelling of the device. This should include:

1. A summary of the non-clinical evidence that falls within this category
2. A discussion of the non-clinical testing considered for the device and support for their selection or omission from the verification and validation studies conducted in this category (that is, what tests were considered and why they were or were not performed)
3. Discussion to support why the evidence presented is sufficient to support the application

Or

4. A statement of why this category of non-clinical laboratory study is not applicable to this case

Note: The sponsor/applicant should explicitly address any existing regional regulatory guidance related to the non-clinical study results provided in this section regarding the subject device.

Health Canada guidance

A medical device licence issued by Health Canada does not mean that the licensed device has been assessed to meet all relevant regulations. It only means that the device has been deemed to meet the requirements of the Medical Device Regulations.

The onus is on manufacturers of radiation-emitting medical devices to ensure that their devices meet all of the national or provincial regulations that apply to their product. For example, the device may be subject to the Radiation Emitting Devices Act and Regulations.

Applicants should also include an Overview.pdf file at the parent heading level of the relevant subchapter. This document should provide a concise summary (typically 1 to 2 pages) of both the IMDRF common content, and the IMDRF Health Canada content. In addition, the overview should include a brief rationale explaining how the submitted evidence supports the application.

Classification

New and amendment applications: Conditionally required – Not required when this type of evidence or testing is clearly not applicable to the device or submission. If scientific judgment is needed to justify why no information is required, then the heading is considered required and the justification should be provided.

3.05.04.01 Study description, study identifier, date of initiation

Folder name: 3.05.04.01-StudyTitle,Identifier,Date(yyyy-mm-dd)

IMDRF common content

No content at this level

This heading should be custom and based on study details and created for each study under the parent heading. The sub headings below would be for this study alone.

Health Canada guidance

This folder should be customized to represent the details of the study. The contents of this folder should be limited to two subfolders: the summary and full report (when required), for the study presented. As described in the Health Canada adapted assembly and technical guide for IMDRF Table of Contents submissions, these subfolders are to be named to ensure the sequence remains as described in the IMDRF ToC (summary then full report).

Further, for each additional custom folder created, the final digit of the heading number should be incremented by 1.

For example, when a fatigue test and wear test are being included, the application would include an overview file in the parent subchapter folder and two subfolders:

• a custom folder named "3.5.01.01-Component A Fatigue Test, MT4203, 2012-03-20" containing two subfolders with the appropriate files:
  • 1-Summ
    • MT4203Summ.pdf
  • 2-Report
    • MT420report.pdf
• a custom folder named "3.5.01.02-Assembly B Wear Testing, MT4584, 2012-04-12" containing:
  • 1-Summ
    • MT4584Summ.pdf
  • 2-Report
    • MT4584Report.pdf

Classification

New and amendment applications: Conditionally required – Required for each study or test presented in this section

3.05.04.01.01 Summary

Folder name: 3.05.04.01.01–Summ

IMDRF common content

This is a summary of the specific study described in the custom heading above.

Health Canada guidance

For detailed information on summary content requirements and expectations, refer to the Definitions section of the Health Canada IMDRF Table of Contents for medical device applications guidance.

Classification

New and amendment applications: Conditionally required – A comprehensive summary is required for each study or test presented in this section. The test summary should be sufficiently detailed to stand alone in describing the evidence.

3.05.04.01.02 Full report

Folder name: 3.05.04.01.02-Report

IMDRF common content

The test report for the test is described in the custom heading above.

Health Canada guidance

For information on full report content requirements and expectations, refer to the Definitions section of the Health Canada IMDRF Table of Contents for medical device applications guidance.

Classification

New and amendment applications: Optional

Folder name: 3.05.05.01-Description

IMDRF common content

The software description should include:

1. A comprehensive overview of significant software features and functions, which may include images, flow charts, and state diagrams as needed to adequately explain the software functionality
2. The version of the software. The version tested must be clearly identified and should match the release version of the software, otherwise justification must be provided
3. Identification of the device features that are controlled by the software, the programming language, hardware platform, operating system (if applicable), use of off-the-shelf software (if applicable), a description of the realization process

If the product is a machine learning-enabled medical device (such as adaptive models, natural language processing, neural networks, and related approaches), please provide, as applicable:

1. a detailed description of each algorithm/model, including its inputs, outputs, data selection and management for training, testing, and validation (terminology may differ in different regions)
2. model selection and evaluation
3. risk management activities
4. materials/approaches used to provide transparency
5. post-market performance monitoring activities

Health Canada guidance

If a device includes software, provide a description of that software and its impact on the safety and effectiveness of the device.

If the software or a previous version of the software has been reviewed by Health Canada, state this clearly and provide the appropriate references (for example, application and/or licence number).

Classification

New and amendment applications: Conditionally required – Required if the device includes software

Folder name: 3.05.05.02-HazardAnalysis

IMDRF common content

The risk management file should be provided and include the risk management plan, risk assessment (for example, hazard analysis), and risk management report.

The risk assessment (for example, hazard analysis) should take into account all device hazards associated with the device’s intended use.

For software that is part of a system, a risk assessment should be performed on the system comprising the software and its whole hardware environment and noted in the software documentation with reference to the particular section of the premarket submission.

IMDRF Health Canada content

The risk management file in this section should specifically relate to the software/hardware. Overall risk analysis should be placed in section 2.08.

For the risk control measures in the risk assessment or hazard analysis, there should be verification of the implementation of the risk control measures and verification of the effectiveness of the implemented risk control measures (that is, the implemented risk control measure reduces risk). This can be accomplished by tracing the identified hazard to the verified specific risk control measures (for example, a requirement ID in the SRS and SDS, a test name and identifier in the testing documentation that shows pass/fail results, a user manual name and identifier, a training manual name and identifier).

Classification

New licence applications: Conditionally required – Required if the device includes software

Amendment licence applications: Conditionally required – When relevant to the amendment

Folder name: 3.05.05.03-SRS

IMDRF common content

The Software Requirements Specifications (SRS) documentation should describe the needs or expectations for a system or software, presented in an organized format, at the software system level or subsystem level, as appropriate, and with sufficient information to understand the traceability of the information with respect to the other software documentation elements (for example, risk management file, software design specification, system and software architecture design chart, software testing).

The SRS documents the requirements for the software which typically specifies inputs and outputs, functions that the software will perform, hardware, performance, interfaces, user interaction, error definition and handling, intended operating environment, safety and security related requirements derived from a risk assessment (hazard analysis) and all ranges, limits, defaults, and specific values that the software will accept.

Classification

New licence applications: Conditionally required – Required if the device includes software

Amendment licence applications: Conditionally required – When relevant to the amendment

Folder name: 3.05.05.04-SADChart

IMDRF common content

The System and Software Architecture Design (SAD) Chart should consist of detailed diagrams of the modules, layers, and interfaces that comprise the device, their relationships, the data inputs/outputs and flow of data, and how users or external products (including information technology (IT) infrastructure and peripherals) interact with the system and software. If the System and Software Architecture Design Chart is included in another document, such as the SRS, a reference to the location of the System and Software Architecture Design Chart in the submission should be included.

Classification

New licence applications: Conditionally required – Required if the device includes software

Amendment licence applications: Conditionally required – When relevant to the amendment

Folder name: 3.05.05.05-SDS

IMDRF common content

Software Design Specification (SDS) documentation should be provided, including sufficient information to understand the technical design details of how the software functions, how the software design completely and correctly implements all the requirements of the SRS, and how the software design traces to the SRS in terms of intended use, functionality, safety, and effectiveness.

In terms of the relationship between the SRS and the SDS, the SRS describes what the software function will do and the SDS describes how the requirements in the SRS are implemented. The information presented in the SDS should be sufficient to ensure that the work performed by the software engineers who created the device software function was clear and unambiguous, with minimal ad hoc design decisions.

Classification

New licence applications: Conditionally required – Required if the device includes software

Amendment licence applications: Conditionally required – When relevant to the amendment

Folder name: 3.05.05.06-TraceabilityAnalysis

IMDRF common content

A Traceability Analysis links together your product design requirements, design specifications, and testing requirements. It also provides a means of tying together identified hazards with the implementation and testing of the mitigations.

IMDRF Health Canada content

The Traceability Analysis can be incorporated into the SRS documentation.

Classification

New licence applications: Conditionally required – Required if the device includes software

Amendment licence applications: Conditionally required – When relevant to the amendment

Folder name: 3.05.05.07-SoftwLifeCycleProcessDesc

IMDRF common content

The software life cycle process description / software development, configuration management, and maintenance practices description should describe the software development life cycle and the processes that are in place to manage the various life cycle activities.

Classification

New licence applications: Conditionally required – Required if the device includes software

Amendment licence applications: Conditionally required – When relevant to the amendment

Folder name: 3.05.05.08-SoftwareTestingV-V

IMDRF common content

You should provide an overall description of the verification and validation activities performed for the final software version. You should provide the applicable test protocols and reports including the expected results, observed results and pass/fail determination.

Note: The discussion should address all of the different hardware configurations and, where applicable, operating systems identified in the labelling.

Health Canada guidance

Applicants should also include an Overview.pdf file at the parent heading level of the relevant subchapter. This document should provide a concise summary (typically 1 to 2 pages) of both the IMDRF common content, and the IMDRF Health Canada content. In addition, the overview should include a brief rationale explaining how the submitted evidence supports the application.

Classification

New and amendment applications: Conditionally required – Not required when this type of evidence or testing is clearly not applicable to the device or submission. If scientific judgment is needed to justify why no information is required, then the heading is considered required and the justification should be provided.

3.05.05.08.01 Study description, study identifier, date of initiation

Folder name: 3.05.05.08.01-StudyTitle,Identifier,Date(yyyy-mm-dd)

Health Canada guidance

This folder should be customized to represent the details of the study. The contents of this folder should be limited to two subfolders: the summary and full report (when required), for the study presented. As described in the Health Canada adapted assembly and technical guide for IMDRF Table of Contents submissions, these subfolders are to be named to ensure the sequence remains as described in the IMDRF ToC (summary then full report).

Further, for each additional custom folder created, the final digit of the heading number should be incremented by 1.

For example, when a fatigue test and wear test are being included, the application would include an overview file in the parent subchapter folder and two subfolders:

• a custom folder named "3.5.01.01-Component A Fatigue Test, MT4203, 2012-03-20" containing two subfolders with the appropriate files:
  • 1-Summ
    • MT4203Summ.pdf
  • 2-Report
    • MT420report.pdf
• a custom folder named "3.5.01.02-Assembly B Wear Testing, MT4584, 2012-04-12" containing:
  • 1-Summ
    • MT4584Summ.pdf
  • 2-Report
    • MT4584Report.pdf

Classification

New and amendment applications: Conditionally required – Required for each study or test presented in this section

3.05.05.08.01.01 Summary

Folder name: 3.05.05.08.01.01-Summ

IMDRF common content

A summary of the specific study described in the custom heading above.

Health Canada guidance

For detailed information on summary content requirements and expectations, refer to the Definitions section of the Health Canada IMDRF Table of Contents for medical device applications guidance.

Classification

New and amendment applications: Conditionally required – A comprehensive summary is required for each study or test presented in this section

The test summary should be sufficiently detailed to stand alone in describing the evidence.

3.05.05.08.01.02 Full report

Folder name: 3.05.05.08.01.02-Report

IMDRF common content

The test report for the test described in the custom heading above.

Health Canada guidance

For information on full report content requirements and expectations, refer to the Definitions section of the Health Canada IMDRF Table of Contents for medical device applications guidance.

Classification

New and amendment applications: Optional

Folder name: 3.05.05.09-RevisionLevelHistory

IMDRF common content

The software version / revision level history documentation should include the history of software versions that were tested and documented as part of verification and validation activities. This typically takes the form of a line-item tabulation including the date, version number that was tested and a brief description of all changes in the version relative to the previously tested version.

The last entry in a line-item tabulation should be the final version to be incorporated in the released device. This entry should also include any differences between the tested version of software and the released version.

Classification

New licence applications: Conditionally required – When software is part of the device

Amendment licence applications: Conditionally required – When relevant to the amendment

Folder name: 3.05.05.10-UnresolvedAnomalies

IMDRF common content

Documentation should include a list of unresolved anomalies present in the software with the following items (for example, in tabular format) for each unresolved anomaly:

1. A description of what the anomaly is and what root cause(s) of the anomaly could be
2. Identification of how the anomaly was discovered and, where possible, identification of the root cause(s) of the anomaly
3. Evaluation of the impact of the anomaly on the device’s safety and effectiveness, including operator usage and human factors considerations
4. Outcome of the evaluation
5. Risk-based rationale for not correcting or fixing the anomaly in alignment with the risk management plan or procedure(s)

Classification

New licence applications: Conditionally required – When software is part of the device

Amendment licence applications: Conditionally required – When relevant to the amendment

Folder name: 3.05.05.11-Cybersecurity

IMDRF common content

For a description of the cybersecurity common content, please refer to IMDRF/CYBER WG/N60 FINAL:2020 “Principles and Practices for Medical Device Cybersecurity”

IMDRF Health Canada content

Guidance document: Pre-market requirements for medical device cybersecurity

Health Canada guidance

Cybersecurity considerations should be included when a medical device contains or consists of software. If cybersecurity considerations are not addressed, the manufacturer should supply evidence to support this decision.

This should include, but is not limited to, the following:

• Cybersecurity vulnerabilities and risk analysis
• Cybersecurity control measures
• Traceability matrix linking cybersecurity controls to identified vulnerabilities and risks

This documentation ensures that all relevant cybersecurity risks have been properly assessed and managed throughout the development lifecycle.

Classification

New licence applications: Conditionally required – When the device contains or consisting of software

Amendment licence applications: Conditionally required – When relevant to the amendment

Folder name: 3.05.05.12-Interoperability

IMDRF common content

If the device can communicate with other devices. Evidence to support the interoperability should be provided.

Classification

New licence applications: Conditionally required – When the results of a risk assessment suggest that there are safety and effectiveness concerns relating to the interoperability of the device

Amendment licence applications: Conditionally required – When relevant to the amendment

Folder name: 3.05.06-Biocomp-Toxicology

IMDRF common content

Studies supporting biocompatibility and assessing toxicology are to be included in this section. Studies to assess the immunological response to animal or human tissues, tissue components or derivatives are to be included in this section. This should include:

1. A list of all materials in direct or indirect contact with the patient or user
2. State conducted tests, applied standards, test protocols, the analysis of data and the summary of results
3. A discussion of the non-clinical testing considered for the device and support for their selection or omission from the verification and validation studies conducted in this category (that is, what tests were considered and why they were or were not performed)
4. Discussion to support why the evidence presented is sufficient to support the application

Or

5. A statement of why this category of non-clinical laboratory study is not applicable to this case

Notes:

1. The sponsor/applicant should explicitly address any existing regional regulatory guidance related to the non-clinical study results provided in this section regarding the subject device.
2. Tests should be conducted on samples from the finished, sterilized (when supplied sterile) device.

Health Canada guidance

Biocompatibility testing characterizes biological responses to materials. If the device comes in contact with the patient, then the biocompatibility of all materials that are potentially in contact with the patient is required. Tests should be conducted on samples from the final product after all manufacturing and processing has been completed (for example, sterilization). Deviations from this must be justified. Generic claims from the raw material supplier are generally insufficient.

Summaries should cover the tests conducted, standards applied, test methodology, pass-fail criteria chosen with justification and provide a summary of the results and conclusions. In general, ISO 10993 standards are taken as the gold standards for biocompatibility. Use of other standards should be justified and compared against ISO 10993 methods.

If a Declaration of Conformity to ISO 10993 standards is used to support the methodology, you must provide:

• a summary of the results 
• a conclusion
  • for example, cytotoxicity testing found mild toxicity (average score 1) for patient-contacting material, therefore the device is considered biocompatible for its intended use

MSDS are not sufficient to demonstrate biocompatibility.

Applicants should also include an Overview.pdf file at the parent heading level of the relevant subchapter. This document should provide a concise summary (typically 1 to 2 pages) of both the IMDRF common content, and the IMDRF Health Canada content. In addition, the overview should include a brief rationale explaining how the submitted evidence supports the application.

Classification

New and amendment applications: Conditionally required – Not required when this type of evidence or testing is clearly not applicable to the device or submission. If scientific judgment is needed to justify why no information is required, then the heading is considered required and the justification should be provided.

3.05.06.01 Study description, study identifier, date of initiation

Folder name: 3.05.06.01-StudyTitle,Identifier,Date(yyyy-mm-dd)

IMDRF common content

No content at this level

This heading should be custom and based on study details and created for each study under the parent heading. The sub headings below would be for this study alone.

Health Canada guidance

This folder should be customized to represent the details of the study. The contents of this folder should be limited to two subfolders: the summary and full report (when required), for the study presented. As described in the Health Canada adapted assembly and technical guide for IMDRF Table of Contents submissions, these subfolders are to be named to ensure the sequence remains as described in the IMDRF ToC (summary then full report).

Further, for each additional custom folder created, the final digit of the heading number should be incremented by 1.

For example, when a fatigue test and wear test are being included, the application would include an overview file in the parent subchapter folder and two subfolders:

• a custom folder named "3.5.01.01-Component A Fatigue Test, MT4203, 2012-03-20" containing two subfolders with the appropriate files:
  • 1-Summ
    • MT4203Summ.pdf
  • 2-Report
    • MT420report.pdf
• a custom folder named "3.5.01.02-Assembly B Wear Testing, MT4584, 2012-04-12" containing:
  • 1-Summ
    • MT4584Summ.pdf
  • 2-Report
    • MT4584Report.pdf

Classification

New and amendment applications: Conditionally required – Required for each study or test presented in this section

3.05.06.01.01 Summary

Folder name: 3.05.06.01.01–Summ

IMDRF common content

This is a summary of the specific study described in the custom heading above.

Health Canada guidance

For detailed information on summary content requirements and expectations, refer to the Definitions section of the Health Canada IMDRF Table of Contents for medical device applications guidance.

Classification

New and amendment applications: Conditionally required – A comprehensive summary is required for each study or test presented in this section The test summary should be sufficiently detailed to stand alone in describing the evidence.

3.05.06.01.02 Full report

Folder name: 3.05.06.01.02-Report

IMDRF common content

The test report for the test described in the custom heading above.

Health Canada guidance

For information on full report content requirements and expectations, refer to the Definitions section of the Health Canada IMDRF Table of Contents for medical device applications guidance.

Classification

New and amendment applications: Optional

Folder name: 3.05.07-Pyrogenicity

IMDRF common content

Studies to support pyrogenicity evaluation of final release, such as endotoxin levels, are to be included in this section. This should include:

1. A summary of the non-clinical evidence that falls within this category
2. A discussion of the non-clinical testing considered for the device and support for their selection or omission from the verification and validation studies conducted in this category (that is, what tests were considered and why they were or were not performed)
3. Discussion to support why the evidence presented is sufficient to support the application

Or

4. A statement of why this category of non-clinical laboratory study is not applicable to this case

Note: The sponsor/applicant should explicitly address any existing regional regulatory guidance related to the non-clinical study results provided in this section regarding the subject device.

Health Canada guidance

When biocompatibility assessment includes systemic toxicity concerns (for instance, acute, subacute or subchronic), pyrogen test data and methods should also be summarized. They should cover frequency of testing, number of units tested, methods of testing, any deviations from this testing and test results.

Applicants should include an Overview.pdf file at the parent heading level of the relevant subchapter. This document should provide a concise summary (typically 1 to 2 pages) of both the IMDRF common content, and the IMDRF Health Canada content. In addition, the overview should include a brief rationale explaining how the submitted evidence supports the application.

Classification

New and amendment applications: Conditionally required – Not required when this type of evidence or testing is clearly not applicable to the device or submission. If scientific judgment is needed to justify why no information is required, then the heading is considered required and the justification should be provided.

3.05.07.01 Study description, study identifier, date of initiation, date of completion

Folder name: 3.05.07.01-StudyTitle,Identifier,Date(yyyy-mm-dd)

IMDRF common content

No content at this level

This heading should be custom and based on study details and created for each study under the parent heading. The sub headings below would be for this study alone.

Health Canada guidance

This folder should be customized to represent the details of the study. The contents of this folder should be limited to two subfolders: the summary and full report (when required), for the study presented. As described in the Health Canada adapted assembly and technical guide for IMDRF Table of Contents submissions, these subfolders are to be named to ensure the sequence remains as described in the IMDRF ToC (summary then full report).

Further, for each additional custom folder created, the final digit of the heading number should be incremented by 1.

For example, when a fatigue test and wear test are being included, the application would include an overview file in the parent subchapter folder and two subfolders:

• a custom folder named "3.5.01.01-Component A Fatigue Test, MT4203, 2012-03-20" containing two subfolders with the appropriate files:
  • 1-Summ
    • MT4203Summ.pdf
  • 2-Report
    • MT420report.pdf
• a custom folder named "3.5.01.02-Assembly B Wear Testing, MT4584, 2012-04-12" containing:
  • 1-Summ
    • MT4584Summ.pdf
  • 2-Report
    • MT4584Report.pdf

Classification

New and amendment applications: Conditionally required – Required for each study or test presented in this section

3.05.07.01.01 Summary

Folder name: 3.05.07.01.01–Summ

IMDRF common content

This is a summary of the specific study described in the custom heading above.

Health Canada guidance

For detailed information on summary content requirements and expectations, refer to the Definitions section of the Health Canada IMDRF Table of Contents for medical device applications guidance.

Classification

New and amendment applications: Conditionally required – A comprehensive summary is required for each study or test presented in this section. The test summary should be sufficiently detailed to stand alone in describing the evidence.

3.05.07.01.02 Full report

Folder name: 3.05.07.01.02-Report

IMDRF common content

The test report for the test is described in the custom heading above.

Health Canada guidance

For information on full report content requirements and expectations, refer to the Definitions section of the Health Canada IMDRF Table of Contents for medical device applications guidance.

Classification

New and amendment applications: Optional

Folder name: 3.05.08-BioMaterialSafety

IMDRF common content

Evaluations performed to demonstrate the safety of materials of biological origin (for example, animal sourced, human sourced material) are to be included in this section. This should include:

1. A description of biological material or derivate
2. State the harvesting, processing, preservation, testing and handling of tissues, cells and substances
3. If applicable, discussion of infectious agents/transmissible agents known to infect the source animal
4. Clarify the origin (including details of donor screening and source country) and describe the tests on validation of removal or inactivation methods of viruses and other pathogens in the manufacturing process
5. A brief summary of process validation should be included to substantiate that manufacturing and screening procedures are in place to minimize biological risks, in particular, with regard to viruses and other transmissible agents
6. The system for recordkeeping to allow traceability from sources to the finished device should be fully described
7. Discussion to support why the evidence presented is sufficient to support the application

Or

8. A statement of why this category of non-clinical laboratory study is not applicable to this case

Note: The sponsor/applicant should explicitly address any existing regional regulatory guidance related to the non-clinical study results provided in this section regarding the subject device

IMDRF Health Canada content

Refer to the guidance on the regulation of medical devices manufactured from or incorporating viable or non-viable animal tissue or their derivatives.

Health Canada guidance

Applicants should include an Overview.pdf file at the parent heading level of the relevant subchapter. This document should provide a concise summary (typically 1 to 2 pages) of both the IMDRF common content, and the IMDRF Health Canada content. In addition, the overview should include a brief rationale explaining how the submitted evidence supports the application.

Classification

New and amendment applications: Conditionally required: Not required when this type of evidence or testing is clearly not applicable to the device or submission. If scientific judgment is needed to justify why no information is required, then the heading is considered required and the justification should be provided.

3.05.08.02 Study description, study identifier, date of initiation

Folder name: 3.05.08.02-StudyTitle,Identifier,Date(yyyy-mm-dd)

IMDRF common content

No content at this level

This heading should be custom and based on study details and created for each study under the parent heading. The sub headings below would be for this study alone.

Health Canada guidance

This folder should be customized to represent the details of the study. The contents of this folder should be limited to two subfolders: the summary and full report (when required), for the study presented. As described in the Health Canada adapted assembly and technical guide for IMDRF Table of Contents submissions, these subfolders are to be named to ensure the sequence remains as described in the IMDRF ToC (summary then full report).

Further, for each additional custom folder created, the final digit of the heading number should be incremented by 1.

For example, when a fatigue test and wear test are being included, the application would include an overview file in the parent subchapter folder and two subfolders:

• a custom folder named "3.5.01.01-Component A Fatigue Test, MT4203, 2012-03-20" containing two subfolders with the appropriate files:
  • 1-Summ
    • MT4203Summ.pdf
  • 2-Report
    • MT420report.pdf
• a custom folder named "3.5.01.02-Assembly B Wear Testing, MT4584, 2012-04-12" containing:
  • 1-Summ
    • MT4584Summ.pdf
  • 2-Report
    • MT4584Report.pdf

Classification

New and amendment applications: Conditionally required– Required for each study or test presented in this section

3.05.08.02.01 Summary

Folder name: 3.05.08.02.01–Summ

IMDRF common content

This is a summary of the specific study described in the custom heading above.

Health Canada guidance

For detailed information on summary content requirements and expectations, refer to the Definitions section of the Health Canada IMDRF Table of Contents for medical device applications guidance.

Classification

New and amendment applications: Conditionally required – A comprehensive summary is required for each study or test presented in this section. The test summary should be sufficiently detailed to stand alone in describing the evidence.

3.05.08.02.02 Full report

Folder name: 3.05.08.02.02-Report

IMDRF common content

The test report for the test described in the custom heading above.

Health Canada guidance

For information on full report content requirements and expectations, refer to the Definitions section of the Health Canada IMDRF Table of Contents for medical device applications guidance.

Classification

New and amendment applications: Optional

Folder name: 3.05.09.01-End-User

IMDRF common content

Information and validation of end-user sterilization where it is necessary for the end-user to sterilize the device. This should include:

1. A description of the sterilization process (method, parameters) and Sterility Assurance Level (SAL)
2. A summary of the non-clinical evidence that falls within this category
3. A discussion of the non-clinical testing considered for the device and support for their selection or omission from the verification and validation studies conducted in this category (that is, what tests were considered and why they were or were not performed)
4. If applicable, the rationale on the durability of the product against two or more sterilization.
5. Discussion to support why the evidence presented is sufficient to support the application.

Or

6. A statement of why this category of non-clinical laboratory study is not applicable to this case

Note: The sponsor/applicant should explicitly address any existing regional regulatory guidance related to the non-clinical study results provided in this section regarding the subject device.

Health Canada guidance

The recommended, validated sterilization method should be stated in the device labelling information.

Applicants should also include an Overview.pdf file at the parent heading level of the relevant subchapter. This document should provide a concise summary (typically 1 to 2 pages) of both the IMDRF common content, and the IMDRF Health Canada content. In addition, the overview should include a brief rationale explaining how the submitted evidence supports the application.

Classification

New and amendment applications: Conditionally required – Not required when this type of evidence or testing is clearly not applicable to the device or submission. If scientific judgment is required to justify why no information is required, then the heading is considered required and the justification should be provided.

3.05.09.01.01 Study description, study identifier, date of initiation

Folder name: 3.05.09.01.01-StudyTitle,Identifier,Date(yyyy-mm-dd)

IMDRF common content

No content at this level

This heading should be custom and based on study details and created for each study under the parent heading. The sub headings below would be for this study alone.

Health Canada guidance

This folder should be customized to represent the details of the study. The contents of this folder should be limited to two subfolders: the summary and full report (when required), for the study presented. As described in the Health Canada adapted assembly and technical guide for IMDRF Table of Contents submissions, these subfolders are to be named to ensure the sequence remains as described in the IMDRF ToC (summary then full report).

Further, for each additional custom folder created, the final digit of the heading number should be incremented by 1.

For example, when a fatigue test and wear test are being included, the application would include an overview file in the parent subchapter folder and two subfolders:

• a custom folder named "3.5.01.01-Component A Fatigue Test, MT4203, 2012-03-20" containing two subfolders with the appropriate files:
  • 1-Summ
    • MT4203Summ.pdf
  • 2-Report
    • MT420report.pdf
• a custom folder named "3.5.01.02-Assembly B Wear Testing, MT4584, 2012-04-12" containing:
  • 1-Summ
    • MT4584Summ.pdf
  • 2-Report
    • MT4584Report.pdf

Classification

New and amendment applications: Conditionally required – Required for each study or test presented in this section

3.05.09.01.01.01 Summary

Folder name: 3.05.09.01.01.01–Summ

IMDRF common content

This is a summary of the specific study described in the custom heading above.

Health Canada guidance

For detailed information on summary content requirements and expectations, refer to the Definitions section of the Health Canada IMDRF Table of Contents for medical device applications guidance.

Classification

New and amendment applications: Conditionally required – A comprehensive summary is required for each study or test presented in this section. The test summary should be sufficiently detailed to stand alone in describing the evidence.

3.05.09.01.01.02 Full report

Folder name: 3.05.09.01.01.02-Report

The test report for the test described in the custom heading above.

Health Canada guidance

For information on full report content requirements and expectations, refer to the Definitions section of the Health Canada IMDRF Table of Contents for medical device applications guidance.

Classification

New and amendment applications: Optional

Folder name: 3.05.09.02-Manufacturer

IMDRF common content

Information and validation of manufacturer sterilization where the device is provided sterile. This should include:

1. A description of the sterilization process (method, parameters) and Sterility Assurance Level (SAL)
2. State if parametric release is used
3. A summary of the non-clinical evidence that falls within this category
4. Information on the ongoing revalidation of the process. Typically, this would consist of arrangements for, or evidence of, revalidation of the packaging and sterilization processes.
5. A discussion of the non-clinical testing considered for the device and support for their selection or omission from the verification and validation studies conducted in this category (that is, what tests were considered and why they were or were not performed)
6. Discussion to support why the evidence presented is sufficient to support the application

Or

7. A statement of why this category of non-clinical laboratory study is not applicable to this case

Note: The sponsor/applicant should explicitly address any existing regional regulatory guidance related to the non-clinical study results provided in this section regarding the subject device.

Health Canada guidance

If the subject device is sold sterile or is to be sterilized, process validation data should include sterility test data, reference to a standardized test method and attestation or evidence of successful validation under real-life conditions under which the product is to be sterilized.

Bioburden determination, culture media used, time and temperature of incubation, controls, number of samples examined and frequency of testing should also be presented. A sterility assurance level (SAL) of 10^-6 is generally required. If a biological indicator was used, its placement must be described and rationalized (for example, "most difficult to sterilize" location). If a group of devices is to be sterilized together, the worst-case scenario or most difficult to sterilize product should be validated.

An attestation can be used. The manufacturer should also demonstrate that they have a process in place to monitor bioburden levels on a regular basis to confirm that the sterilization method remains valid. Alternatively, a method of parametric release maybe proposed and validated. If a process challenge device was used to assess the sterilization process, it must be shown to have comparative resistance or a greater challenge to sterilization than the biological indicators placed inside the product/packaging.

Applicants should also include an Overview.pdf file at the parent heading level of the relevant subchapter. This document should provide a concise summary (typically 1 to 2 pages) of both the IMDRF common content, and the IMDRF Health Canada content. In addition, the overview should include a brief rationale explaining how the submitted evidence supports the application.

Classification

New and amendment applications: Conditionally required – Not required when this type of evidence or testing is clearly not applicable to the device or submission. If scientific judgment is required to justify why no information is required, then the heading is considered required and the justification should be provided.

3.05.09.02.01 Study description, study identifier, date of initiation

Folder name: 3.05.09.02.01-StudyTitle,Identifier,Date(yyyy-mm-dd)

IMDRF common content

No content at this level

This heading should be custom and based on study details and created for each study under the parent heading. The sub headings below would be for this study alone.

Health Canada guidance

This folder should be customized to represent the details of the study. The contents of this folder should be limited to two subfolders: the summary and full report (when required), for the study presented. As described in the Health Canada adapted assembly and technical guide for IMDRF Table of Contents submissions, these subfolders are to be named to ensure the sequence remains as described in the IMDRF ToC (summary then full report).

Further, for each additional custom folder created, the final digit of the heading number should be incremented by 1.

For example, when a fatigue test and wear test are being included, the application would include an overview file in the parent subchapter folder and two subfolders:

• a custom folder named "3.5.01.01-Component A Fatigue Test, MT4203, 2012-03-20" containing two subfolders with the appropriate files:
  • 1-Summ
    • MT4203Summ.pdf
  • 2-Report
    • MT420report.pdf
• a custom folder named "3.5.01.02-Assembly B Wear Testing, MT4584, 2012-04-12" containing:
  • 1-Summ
    • MT4584Summ.pdf
  • 2-Report
    • MT4584Report.pdf

Classification

New and amendment applications: Conditionally required – Required for each study or test presented in this section

3.05.09.02.01.01 Summary

Folder name: 3.05.09.02.01.01–Summ

IMDRF common content

This is a summary of the specific study described in the custom heading above.

Health Canada guidance

For detailed information on summary content requirements and expectations, refer to the Definitions section of the Health Canada IMDRF Table of Contents for medical device applications guidance.

Classification

New and amendment applications: Conditionally required – A comprehensive summary is required for each study or test presented in this section. The test summary should be sufficiently detailed to stand alone in describing the evidence.

3.05.09.02.01.02 Full report

Folder name: 3.05.09.02.01.02-Report

IMDRF common content

The test report for the test described in the custom heading above.

Health Canada guidance

For information on full report content requirements and expectations, refer to the Definitions section of the Health Canada IMDRF Table of Contents for medical device applications guidance.

Classification

New and amendment applications: Optional

Folder name: 3.05.09.03-ResidualTox

IMDRF common content

Contain the information on the testing for sterilant residues, where the device is supplied sterile and sterilized using a method susceptible to residues. This should include:

1. A summary of the non-clinical evidence that falls within this category
2. A discussion of the non-clinical testing considered for the device and support for their selection or omission from the verification and validation studies conducted in this category (that is, what tests were considered and why they were or were not performed)
3. Discussion to support why the evidence presented is sufficient to support the application.

Or

4. A statement of why this category of non-clinical laboratory study is not

Note: The sponsor/applicant should explicitly address any existing regional regulatory guidance related to the non-clinical study results provided in this section regarding the subject device.

Health Canada guidance

For ethylene oxide residuals, levels should be within the acceptable levels (recommended by the most current version of ISO 10993-7) in consideration of the body or tissue contact duration of the device. If another sterilization method was used, a description of how residual toxicity concerns were addressed should be provided.

Applicants should also include an Overview.pdf file at the parent heading level of the relevant subchapter. This document should provide a concise summary (typically 1 to 2 pages) of both the IMDRF common content, and the IMDRF Health Canada content. In addition, the overview should include a brief rationale explaining how the submitted evidence supports the application.

Classification

New and amendment applications: Conditionally required – Not required when this type of evidence/testing is clearly not applicable to the device or submission. If scientific judgment is required to justify why no information is required, then the heading is considered required and the justification should be provided.

3.05.09.03.01 Study description, study identifier, date of initiation

Folder name: 3.05.09.03.01-StudyTitle,Identifier,Date(yyyy-mm-dd)

IMDRF common content

No content at this level

This heading should be custom and based on study details and created for each study under the parent heading. The sub headings below would be for this study alone.

Health Canada guidance

This folder should be customized to represent the details of the study. The contents of this folder should be limited to two subfolders: the summary and full report (when required), for the study presented. As described in the Health Canada adapted assembly and technical guide for IMDRF Table of Contents submissions, these subfolders are to be named to ensure the sequence remains as described in the IMDRF ToC (summary then full report).

Further, for each additional custom folder created, the final digit of the heading number should be incremented by 1.

For example, when a fatigue test and wear test are being included, the application would include an overview file in the parent subchapter folder and two subfolders:

• a custom folder named "3.5.01.01-Component A Fatigue Test, MT4203, 2012-03-20" containing two subfolders with the appropriate files:
  • 1-Summ
    • MT4203Summ.pdf
  • 2-Report
    • MT420report.pdf
• a custom folder named "3.5.01.02-Assembly B Wear Testing, MT4584, 2012-04-12" containing:
  • 1-Summ
    • MT4584Summ.pdf
  • 2-Report
    • MT4584Report.pdf

Classification

New and amendment applications: Conditionally required – Required for each study or test presented in this section

3.05.09.03.01.01 Summary

Folder name: 3.05.09.03.01.01–Summ

IMDRF common content

This is a summary of the specific study described in the custom heading above.

Health Canada guidance

For detailed information on summary content requirements and expectations, refer to the Definitions section of the Health Canada IMDRF Table of Contents for medical device applications guidance.

Classification

New and amendment applications: Conditionally required – A comprehensive summary is required for each study or test presented in this section. The test summary should be sufficiently detailed to stand alone in describing the evidence.

3.05.09.03.01.02 Full report

Folder name: 3.05.09.03.01.02-Report

The test report for the test described in the custom heading above.

Health Canada guidance

For information on full report content requirements and expectations, refer to the Definitions section of the Health Canada IMDRF Table of Contents for medical device applications guidance.

Classification

New and amendment applications: Optional

Folder name: 3.05.09.04-Clean-DisinfectVal

IMDRF common content

Contains information on the validation of cleaning and disinfection instructions for reusable devices. This should include:

1. A summary of the non-clinical evidence that falls within this category
2. A discussion of the non-clinical testing considered for the device and support for their selection or omission from the verification and validation studies conducted in this category (that is, what tests were considered and why they were or were not performed)
3. Discussion to support why the evidence presented is sufficient to support the application.

Or

4. A statement of why this category of non-clinical laboratory study is not applicable to this case

Note: The sponsor/applicant should explicitly address any existing regional regulatory guidance related to the non-clinical study results provided in this section regarding the subject device.

Health Canada guidance

Applicants should include an Overview.pdf file at the parent heading level of the relevant subchapter. This document should provide a concise summary (typically 1 to 2 pages) of both the IMDRF common content, and the IMDRF Health Canada content. In addition, the overview should include a brief rationale explaining how the submitted evidence supports the application.

Classification

New and amendment applications: Conditionally required – Not required when this type of evidence or testing is clearly not applicable to the device or submission. If scientific judgment is needed to justify why no information is required, then the heading is considered required and the justification should be provided.

3.05.09.04.01 Study description, study identifier, date of initiation

Folder name: 3.05.09.04.01-StudyTitle,Identifier,Date(yyyy-mm-dd)

IMDRF common content

No content at this level

This heading should be custom and based on study details and created for each study under the parent heading. The sub headings below would be for this study alone.

Health Canada guidance

This folder should be customized to represent the details of the study. The contents of this folder should be limited to two subfolders: the summary and full report (when required), for the study presented. As described in the Health Canada adapted assembly and technical guide for IMDRF Table of Contents submissions, these subfolders are to be named to ensure the sequence remains as described in the IMDRF ToC (summary then full report).

Further, for each additional custom folder created, the final digit of the heading number should be incremented by 1.

For example, when a fatigue test and wear test are being included, the application would include an overview file in the parent subchapter folder and two subfolders:

• a custom folder named "3.5.01.01-Component A Fatigue Test, MT4203, 2012-03-20" containing two subfolders with the appropriate files:
  • 1-Summ
    • MT4203Summ.pdf
  • 2-Report
    • MT420report.pdf
• a custom folder named "3.5.01.02-Assembly B Wear Testing, MT4584, 2012-04-12" containing:
  • 1-Summ
    • MT4584Summ.pdf
  • 2-Report
    • MT4584Report.pdf

Classification

New and amendment applications: Conditionally required – Required for each study or test presented in this section

3.05.09.04.01.01 Summary

Folder name: 3.05.09.04.01.01–Summ

IMDRF common content

This is a summary of the specific study described in the custom heading above.

Health Canada guidance

For detailed information on summary content requirements and expectations, refer to the Definitions section of the Health Canada IMDRF Table of Contents for medical device applications guidance.

Classification

New and amendment applications: Conditionally required – A comprehensive summary is required for each study or test presented in this section. The test summary should be sufficiently detailed to stand alone in describing the evidence.

3.05.09.04.01.02 Full report

Folder name: 3.05.09.04.01.02-Report

The test report for the test described in the custom heading above.

Health Canada guidance

For information on full report content requirements and expectations, refer to the Definitions section of the Health Canada IMDRF Table of Contents for medical device applications guidance.

Classification

New and amendment applications: Optional

Folder name: 3.05.09.05-ReprocessingofSUDs

IMDRF common content

The required validation data including cleaning and sterilization data, and functional performance data demonstrating that each single use device (SUD) will continue to meet specifications after the maximum number of times the device is reprocessed as intended by the person submitting the premarket notification.

Note: The sponsor/applicant should explicitly address any existing regional regulatory guidance related to the non-clinical study results provided in this section regarding the subject device.

Health Canada guidance

Applicants should include an Overview.pdf file at the parent heading level of the relevant subchapter. This document should provide a concise summary (typically 1–2 pages) of both the IMDRF common content, and the IMDRF Health Canada content. In addition, the overview should include a brief rationale explaining how the submitted evidence supports the application.

Classification

New and amendment applications: Conditionally required – When the purpose of the submission includes seeking a licence for a reprocessed single-use device

3.05.09.05.01 Study description, study identifier, date of initiation

Folder name: 3.05.09.05.01-StudyTitle,Identifier,Date(yyyy-mm-dd)

IMDRF common content

No content at this level

This heading should be custom and based on study details and created for each study under the parent heading. The sub headings below would be for this study alone.

Health Canada guidance

This folder should be customized to represent the details of the study. The contents of this folder should be limited to two subfolders: the summary and full report (when required), for the study presented. As described in the Health Canada adapted assembly and technical guide for IMDRF Table of Contents submissions, these subfolders are to be named to ensure the sequence remains as described in the IMDRF ToC (summary then full report).

Further, for each additional custom folder created, the final digit of the heading number should be incremented by 1.

For example, when a fatigue test and wear test are being included, the application would include an overview file in the parent subchapter folder and two subfolders:

• a custom folder named "3.5.01.01-Component A Fatigue Test, MT4203, 2012-03-20" containing two subfolders with the appropriate files:
  • 1-Summ
    • MT4203Summ.pdf
  • 2-Report
    • MT420report.pdf
• a custom folder named "3.5.01.02-Assembly B Wear Testing, MT4584, 2012-04-12" containing:
  • 1-Summ
    • MT4584Summ.pdf
  • 2-Report
    • MT4584Report.pdf

Classification

New and amendment applications: Conditionally required – Required for each study or test presented in this section

3.05.09.05.01.01 Summary

Folder name: 3.05.09.05.01.01–Summ

IMDRF common content

This is a summary of the specific study described in the custom heading above.

Health Canada guidance

For detailed information on summary content requirements and expectations, refer to the Definitions section of the Health Canada IMDRF Table of Contents for medical device applications guidance.

Classification

New and amendment applications: Conditionally required – A comprehensive summary is required for each study or test presented in this section. The test summary should be sufficiently detailed to stand alone in describing the evidence.

3.05.09.05.01.02 Full report

Folder name: 3.05.09.05.01.02-Report

IMDRF common content

The test report for the test described in the custom heading above.

Health Canada guidance

For information on full report content requirements and expectations, refer to the Definitions section of the Health Canada IMDRF Table of Contents for medical device applications guidance.

Classification

New and amendment applications: Optional

Folder name: 3.05.10-AnimalTesting

IMDRF common content

Contains information about any animal studies conducted to support the submission. This should include:

1. A summary of the non-clinical evidence that falls within this category
2. A discussion of the non-clinical testing considered for the device and support for their selection or omission from the verification and validation studies conducted in this category (that is, what tests were considered and why they were or were not performed)
3. Discussion to support why the evidence presented is sufficient to support the application.

Or

4. A statement of why this category of non-clinical laboratory study is not applicable to this case.

Note: The sponsor/applicant should explicitly address any existing regional regulatory guidance related to the non-clinical study results provided in this section regarding the subject device.

Health Canada guidance

Animal studies should be undertaken using good laboratory practices. The study conclusion should consider the device's interaction with animal fluids and tissues and the safety and functional effectiveness of the device in the experimental animal model. The rationale (and limitations) of selecting the particular animal model should be discussed.

This section should not include animal studies supporting biocompatibility.

Applicants should also include an Overview.pdf file at the parent heading level of the relevant subchapter. This document should provide a concise summary (typically 1–2 pages) of both the IMDRF common content, and the IMDRF Health Canada content. In addition, the overview should include a brief rationale explaining how the submitted evidence supports the application.

Classification

New and amendment applications: Conditionally required – Not required when this type of evidence or testing is clearly not applicable to the device or submission. If scientific judgment is needed to justify why no information is required, then the heading is considered required and the justification should be provided.

3.05.10.01 Study description, study identifier, date of initiation, date of completion

Folder name: 3.05.10.01-StudyTitle,Identifier,Date(yyyy-mm-dd)

IMDRF common content

No content at this level

This heading should be custom and based on study details and created for each study under the parent heading. The sub headings below would be for this study alone.

Health Canada guidance

This folder should be customized to represent the details of the study. The contents of this folder should be limited to two subfolders: the summary and full report (when required), for the study presented. As described in the Health Canada adapted assembly and technical guide for IMDRF Table of Contents submissions, these subfolders are to be named to ensure the sequence remains as described in the IMDRF ToC (summary then full report).

Further, for each additional custom folder created, the final digit of the heading number should be incremented by 1.

For example, when a fatigue test and wear test are being included, the application would include an overview file in the parent subchapter folder and two subfolders:

• a custom folder named "3.5.01.01-Component A Fatigue Test, MT4203, 2012-03-20" containing two subfolders with the appropriate files:
  • 1-Summ
    • MT4203Summ.pdf
  • 2-Report
    • MT420report.pdf
• a custom folder named "3.5.01.02-Assembly B Wear Testing, MT4584, 2012-04-12" containing:
  • 1-Summ
    • MT4584Summ.pdf
  • 2-Report
    • MT4584Report.pdf

Classification

New and amendment applications: Conditionally required – Required for each study or test presented in this section

3.05.10.01.01 Summary

Folder name: 3.05.10.01.01–Summ

IMDRF common content

This is a summary of the specific study described in the custom heading above.

Health Canada guidance

For detailed information on summary content requirements and expectations, refer to the Definitions section of the Health Canada IMDRF Table of Contents for medical device applications guidance.

Classification

New and amendment applications: Conditionally required – A comprehensive summary is required for each study or test presented in this section. The test summary should be sufficiently detailed to stand alone in describing the evidence.

3.05.10.01.02 Full report

Folder name: 3.05.10.01.02-Report

IMDRF common content

The test report for the test is described in the custom heading above.

Health Canada guidance

For information on full report content requirements and expectations, refer to the Definitions section of the Health Canada IMDRF Table of Contents for medical device applications guidance.

Classification

New and amendment applications: Optional

Folder name: 3.05.11-Usability-HumanFactors

IMDRF common content

Studies specifically assessing the instructions and/or device design in terms of impact of human behaviour, abilities, limitations, and other characteristics on the ability of the device to perform as intended should be included here. This should include:

1. A summary of the non-clinical evidence that falls within this category
2. A statement of the test environment and relation to the intended use environment
3. A discussion of the non-clinical testing considered for the device and support for their selection or omission from the verification and validation studies conducted in this category (that is, what tests were considered and why they were or were not performed)
4. If a clinical study has been conducted that includes human factors/usability endpoints, reference to the studies and endpoints should be made, but full results do not need to be repeated
5. Discussion to support why the evidence presented is sufficient to support the application.

Or

6. A statement of why this category of non-clinical laboratory study is not applicable to this case

Notes:

1. If a clinical study has been conducted that includes usability/human factors endpoints, reference to the studies and endpoints should be made, but full results do not need to be repeated and should be included in Chapter 4: Clinical evidence.
2. The sponsor/applicant should explicitly address any existing regional regulatory guidance related to the non-clinical study results provided in this section regarding the subject device.

Health Canada guidance

Applicants should include an Overview.pdf file at the parent heading level of the relevant subchapter. This document should provide a concise summary (typically 1 to 2 pages) of both the IMDRF common content, and the IMDRF Health Canada content. In addition, the overview should include a brief rationale explaining how the submitted evidence supports the application.

Classification

New and amendment applications: Conditionally required – Not required when this type of evidence or testing is clearly not applicable to the device or submission. If scientific judgment is needed to justify why no information is required, then the heading is considered required and the justification should be provided.

3.05.11.01 Study description, study identifier, date of initiation

Folder name: 3.05.11.01-StudyTitle,Identifier,Date(yyyy-mm-dd)

IMDRF common content

No content at this level

This heading should be custom and based on study details and created for each study under the parent heading. The sub headings below would be for this study alone.

Health Canada guidance

This folder should be customized to represent the details of the study. The contents of this folder should be limited to two subfolders: the summary and full report (when required), for the study presented. As described in the Health Canada adapted assembly and technical guide for IMDRF Table of Contents submissions, these subfolders are to be named to ensure the sequence remains as described in the IMDRF ToC (summary then full report).

Further, for each additional custom folder created, the final digit of the heading number should be incremented by 1.

For example, when a fatigue test and wear test are being included, the application would include an overview file in the parent subchapter folder and two subfolders:

• a custom folder named "3.5.01.01-Component A Fatigue Test, MT4203, 2012-03-20" containing two subfolders with the appropriate files:
  • 1-Summ
    • MT4203Summ.pdf
  • 2-Report
    • MT420report.pdf
• a custom folder named "3.5.01.02-Assembly B Wear Testing, MT4584, 2012-04-12" containing:
  • 1-Summ
    • MT4584Summ.pdf
  • 2-Report
    • MT4584Report.pdf

Classification

New and amendment applications: Conditionally required – Required for each study or test presented in this section

3.05.11.01.01 Summary

Folder name: 3.05.11.01.01–Summ

IMDRF common content

This is a summary of the specific study described in the custom heading above.

Health Canada guidance

For detailed information on summary content requirements and expectations, refer to the Definitions section of the Health Canada IMDRF Table of Contents for medical device applications guidance.

Classification

New and amendment applications: Conditionally required – A comprehensive summary is required for each study or test presented in this section. The test summary should be sufficiently detailed to stand alone in describing the evidence.

3.05.11.01.02 Full report

Folder name: 3.05.11.01.02-Report

IMDRF common content

The test report for the test described in the custom heading above.

Health Canada guidance

For information on full report content requirements and expectations, refer to the Definitions section of the Health Canada IMDRF Table of Contents for medical device applications guidance.

Classification

New and amendment applications: Optional

Folder name: 3.07.01-ProductStability

IMDRF common content

Contains details relating to product stability under specified storage conditions and in final packaging or simulated conditions. This should include:

1. A statement of the shelf-life (for each component if there are differences between components) and the proposed storage condition for the device
2. A summary of the non-clinical evidence, covering shelf-life period when stored at the proposed storage condition, that falls within this category
3. A discussion of the non-clinical testing considered for the device and support for their selection or omission from the verification and validation studies conducted in this category (that is, what tests were considered and why they were or were not performed)
4. Discussion to support why the evidence presented is sufficient to support the application
5. Evidence to support stability of the medicinal substance contained in the device at the proposed storage condition
6. Evidence of in-use stability supporting the stability during actual routine use of the device (real or simulated)

Or

7. A statement of why this category of non-clinical laboratory study is not applicable to this case

Note: The sponsor/applicant should explicitly address any existing regional regulatory guidance related to the non-clinical study results provided in this section regarding the subject device.

Health Canada guidance

If the product is subject to a shelf-life, shelf-life testing should be provided and the claimed shelf-life clearly stated. The method used (for example, accelerated versus real time) should be provided along with the storage conditions used and the state of the product when tested (for example, sterilized, production version, prototype, transportation, simulation). Devices containing materials of unknown stability should have real-time data.

Applicants should also include an Overview.pdf file at the parent heading level of the relevant subchapter. This document should provide a concise summary (typically 1 to 2 pages) of both the IMDRF common content, and the IMDRF Health Canada content. In addition, the overview should include a brief rationale explaining how the submitted evidence supports the application.

Classification

New and amendment applications: Conditionally required: Not required when this type of evidence or testing is clearly not applicable to the device or submission. If scientific judgment is needed to justify why no information is required, then the heading is considered required, and the justification should be provided.

3.07.01.01 Study description, study identifier, date of initiation

Folder name: 3.07.01.01-StudyTitle,Identifier,Date(yyyy-mm-dd)

IMDRF common content

No content at this level

This heading should be custom and based on study details and created for each study under the parent heading. The sub headings below would be for this study alone.

Health Canada guidance

This folder should be customized to represent the details of the study. The contents of this folder should be limited to two subfolders: the summary and full report (when required), for the study presented. As described in the Health Canada adapted assembly and technical guide for IMDRF Table of Contents submissions, these subfolders are to be named to ensure the sequence remains as described in the IMDRF ToC (summary then full report).

Further, for each additional custom folder created, the final digit of the heading number should be incremented by 1.

For example, when a fatigue test and wear test are being included, the application would include an overview file in the parent subchapter folder and two subfolders:

• a custom folder named "3.5.01.01-Component A Fatigue Test, MT4203, 2012-03-20" containing two subfolders with the appropriate files:
  • 1-Summ
    • MT4203Summ.pdf
  • 2-Report
    • MT420report.pdf
• a custom folder named "3.5.01.02-Assembly B Wear Testing, MT4584, 2012-04-12" containing:
  • 1-Summ
    • MT4584Summ.pdf
  • 2-Report
    • MT4584Report.pdf

Classification

New and amendment applications: Conditionally required – Required for each study or test presented in this section

3.07.01.01.01 Summary

Folder name: 3.07.01.01.01–Summ

IMDRF common content

This is a summary of the specific study described in the custom heading above.

Health Canada guidance

For detailed information on summary content requirements and expectations, refer to the Definitions section of the Health Canada IMDRF Table of Contents for medical device applications guidance.

Classification

New and amendment applications: Conditionally required – A comprehensive summary is required for each study or test presented in this section. The test summary should be sufficiently detailed to stand alone in describing the evidence.

3.07.01.01.02 Full report

Folder name: 3.07.01.01.02-Report

IMDRF common content

The test report for the test described in the custom heading above.

Health Canada guidance

For information on full report content requirements and expectations, refer to the Definitions section of the Health Canada IMDRF Table of Contents for medical device applications guidance.

Classification

New and amendment applications: Optional

Folder name: 3.07.02-PackageVal

IMDRF common content

Contains details relating to package integrity over the claimed shelf-life and in the packaging and distribution environment (transport and packaging validation) and when applicable, following exposure to the sterilization process. This should include:

1. A summary of the non-clinical evidence, covering shelf-life period, that falls within this category
2. A discussion of the non-clinical testing considered for the device and support for their selection or omission from the verification and validation studies conducted in this category (that is, what tests were considered and why they were or were not performed)
3. Discussion to support why the evidence presented is sufficient to support the application

Or

4. A statement of why this category of non-clinical laboratory study is not applicable to this case

Note: The sponsor/applicant should explicitly address any existing regional regulatory guidance related to the non-clinical study results provided in this section regarding the subject device.

Health Canada guidance

If the device requires special packaging (for example, considerations related to sterility, humidity, light sensitivity, pressure or oxidative reaction under irradiation), you should provide evidence that this has been addressed.

Likewise, evidence should be provided to demonstrate that the integrity of the device and the internal environment are maintained by the device packaging during handling, transport and storage (for the claimed shelf life).

In the case of sterility, ensure that the test methods address both seal integrity and sterility (for example, bubble test, dye penetration test, etc.).

Applicants should also include an Overview.pdf file at the parent heading level of the relevant subchapter. This document should provide a concise summary (typically 1 to 2 pages) of both the IMDRF common content, and the IMDRF Health Canada content. In addition, the overview should include a brief rationale explaining how the submitted evidence supports the application.

Classification

New and amendment applications: Conditionally required – Not required when this type of evidence or testing is clearly not applicable to the device or submission. If scientific judgment is needed to justify why no information is required, then the heading is considered required and the justification should be provided.

3.07.02.01 Study description, study identifier, date of initiation

Folder name: 3.07.02.01-StudyTitle,Identifier,Date(yyyy-mm-dd)

IMDRF common content

No content at this level

This heading should be custom and based on study details and created for each study under the parent heading. The sub headings below would be for this study alone.

Health Canada guidance

This folder should be customized to represent the details of the study. The contents of this folder should be limited to two subfolders: the summary and full report (when required), for the study presented. As described in the Health Canada adapted assembly and technical guide for IMDRF Table of Contents submissions, these subfolders are to be named to ensure the sequence remains as described in the IMDRF ToC (summary then full report).

Further, for each additional custom folder created, the final digit of the heading number should be incremented by 1.

For example, when a fatigue test and wear test are being included, the application would include an overview file in the parent subchapter folder and two subfolders:

• a custom folder named "3.5.01.01-Component A Fatigue Test, MT4203, 2012-03-20" containing two subfolders with the appropriate files:
  • 1-Summ
    • MT4203Summ.pdf
  • 2-Report
    • MT420report.pdf
• a custom folder named "3.5.01.02-Assembly B Wear Testing, MT4584, 2012-04-12" containing:
  • 1-Summ
    • MT4584Summ.pdf
  • 2-Report
    • MT4584Report.pdf

Classification

New and amendment applications: Conditionally required – Required for each study or test presented in this section

3.07.02.01.01 Summary

Folder name: 3.07.02.01.01–Summ

IMDRF common content

This is a summary of the specific study described in the custom heading above.

Health Canada guidance

For detailed information on summary content requirements and expectations, refer to the Definitions section of the Health Canada IMDRF Table of Contents for medical device applications guidance.

Classification

New and amendment applications: Conditionally required – A comprehensive summary is required for each study or test presented in this section. The test summary should be sufficiently detailed to stand alone in describing the evidence.

3.07.02.01.02 Full report

Folder name: 3.07.02.01.02-Report

IMDRF common content

The test report for the test described in the custom heading above.

Health Canada guidance

For information on full report content requirements and expectations, refer to the Definitions section of the Health Canada IMDRF Table of Contents for medical device applications guidance.

Classification

New and amendment applications: Optional