Class 3, non-in vitro diagnostic devices (nIVD), new and amendment applications

(PDF version, 720 KB, 77 pages)

1 - Regional Administrative

Folder name: 1-REG ADMIN

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

1.01 - Cover Letter

Folder name: 1.01-Cover Letter

IMDRF common content

The cover letter should state applicant or sponsor name and/or their authorized representative, the type of submission, the common name of the device (if applicable), device trade name or proprietary name (both of the base device and a new name if one is given to the new version/model of the device) and include the purpose of the application, including any changes being made to existing approvals.
If applicable and accepted by the regulator, it should include information pertaining to any Master Files referenced by the submission.
If applicable, acknowledgement that a device sample has been submitted or offered alternatives to allow the regulator to view or access the device (when the regulator requests a sample).
If the submission is requesting approval of a change that is the result of CAPA due to a recall, this should be stated.
If the submission is in response to a request for information from the regulator this should be stated and the date of that letter should be included as well as any reference number(s).
If the submission is unsolicited information (where accepted), this should be stated and any related reference number(s) provided.

Note: The cover letter should not contain any detailed scientific information.

Health Canada guidance

Any information submitted to Health Canada should be accompanied by a cover letter. The cover letter should include the purpose of the application and a brief description of the package being submitted. It may also include information pertaining to Proprietary Information Submission.

Classification

New and amendment applications:

Required

1.03 - List of Terms/Acronyms

Folder name: 1.03-List of Terms-Acronyms

IMDRF common content

Terms or acronyms used in the submission that require definition, should be defined here.

Classification

New and amendment applications:

Required

1.04 - Application Form/Administrative Information

Folder name: 1.04-Application Form-Administrative Info

IMDRF Health Canada content

A copy of the relevant Health Canada Application and Fee Forms for the application - refer to this page for the most up to date forms.

Health Canada guidance

For further information on how to complete the Health Canada Medical Device Licence form consult our Guidance Document - How to Complete the Application for a New Medical Device Licence.

Classification

New and amendment applications:

Required

1.06 - Quality Management System, Full Quality System or Other Regulatory Certificates

Folder name: 1.06-QMS Full QS or Other Regulatory Certs

IMDRF Health Canada content

This subsection includes a copy of the quality management system certificate certifying that the quality management system under which the device is designed and manufactured satisfies CAN/CSA ISO 13485, Medical devices - Quality management systems - Requirements for regulatory purposes. Health Canada will only accept quality system certificates that have been issued by special third party auditing organizations recognized by the Minister in accordance with Section 32.1 of the Medical Devices Regulations.

Classification

New licence applications:

Required

Amendment licence applications:

Not required

1.09 - Pre-Submission Correspondence and Previous Regulator Interactions

Folder name: 1.09-Pre-Submission Correspondence-Previous Regulator Interactions

IMDRF common content

During the product lifecycle, pre-submission correspondence, including teleconferences or meetings, may be held between the regulator and the applicant. Further, the specific subject device may have been subject to previous regulatory submissions to the regulator. The contents should be limited to the subject device as similar devices are addressed in other areas of the submission. If applicable, the following elements should be provided:
1. List prior submission or pre-submissions where regulator feedback was provided
2. Prior submissions should include identification of submission #
3. For any pre-submission activities that have not previously been assigned any tracking/reference number, include the information package that is submitted prior to pre-submission meetings, the meeting agenda, any presentation slides, final meeting minutes, responses to any action items arising from the meetings, and any email correspondence related to specific aspects of the application.
4. Issues identified by the regulator in prior submissions (i.e., clinical study applications, withdrawn/deleted/denied marketing submission) for the subject device
5. Issues identified and advice provided by the regulator in pre-submission interactions between the regulator and the applicant/sponsor.
6. Explain how and where the prior advice was addressed within the submission
OR
Affirmatively state there has been no prior submissions and/or pre-submission interactions for the specific device that is the subject of the current submission.

Note: The scope of this section is limited to the particular regulator to which the submission is being submitted (i.e. Health Canada does not need pre-submission information relating to interactions with ANVISA).

Classification

New licence applications:

Conditionally required - When relevant to the application.

Amendment licence applications:

Conditionally required - When relevant to the amendment.

1.12 - Letters of Reference for Master Files

Folder name: 1.12-Letters of Reference for Master Files

IMDRF common content

Letter from any Master File owner granting access to the information in the master file. The letter should specify the scope of access granted.

Classification

New and amendment applications:

Conditionally required - When a Master File is referenced

1.14 - Other Regional Administrative Information

Folder name: 1.14-Other Regional Administrative Info

IMDRF common content

Heading for other information that may be important to the submission but that does not fit in any of the other headings of this chapter.

Classification

New and amendment applications:

Conditionally required - When information is requested by the regulator (through guidance documents or other communication) but does not belong in any of the other headings of this Chapter

2 - Submission Context

Folder name: 2-CONTEXT

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

2.02 - General Summary of Submission

Folder name: 2.02-General Summary of Submission

IMDRF common content

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

IMDRF Health Canada content

If amendment or new submission based on currently licenced device(s), the Canadian Medical Device Licence Number(s) should be provided along with the description of the change requested.

Classification

New and amendment applications:

Required

2.04 - Device Description

Folder name: 2.04-Device Description

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

Classification

New and amendment applications:

Required

2.04.01 - Comprehensive Device Description and Principle of Operation

Folder name: 2.04.01-Comprehensive Device Desc-Principle of Op

IMDRF common content

A general description of the device, including:
1. A statement of the device name
2. What the device does?
3. Who uses it and for what? (high level statement)
4. Where to use it? (places/environment where the device is intended to be used)
5. How it works? Including theory surrounding feature/variants/operating modes that enable the device to be used for indications/intended use (principle of operation/mechanism of action).
6. If applicable, labelled pictorial representation (diagrams, photos, drawings).
7. If system, how the components relate?
8. If applicable, identify if the device incorporates software/firmware and its role
Product specification, including:
1. Physical characteristics or relevance to the end user (dimensions, weight)
2. Features and operating modes
3. Input specifications (e.g. electrical power requirements, settings and associated allowable ranges/limits)
4. Output and performance characteristics (e.g. range and type of energy delivered, resolution of images)
5. If applicable, an indication of the variants/models of the devices and a summary of the differences in specifications of the variants (comparison table and/or pictures/diagrams with supporting text).
Engineering diagrams/prints/schematics of the device.
List of accessories intended to be used in combination with the devices.
Indication of any other medical devices or general product intended to be used in combination with the medical device (e.g. infusion sets and infusion pumps, bipolar electrode and RF equipment).
Components or accessories that can be sold separately should be identified.
If approved by the regulator, provide the approval number and identification for each component or accessory.
If the device is to be sterilized, an indication of who is to perform the sterilization and by what method (e.g. EtO, gamma irradiation, dry heat) OR an affirmative statement that the device is non-sterile when used.
Note: The validation report is not expected be presented at this point, only the device sterility condition shall be indicated here. If appropriate, for the validation report, see Chapter 3 – Non-Clinical Studies.
Summary of the composition of the device including, at minimum, the material specification and/or chemical composition of the materials that have direct or indirect contact with the user and/or patient. When required, full details to support how these specifications are met are to be provided in CH3.5.02 – Chemical/Material Characterization.
Note: If applicable, chemicals may be identified using either the IUPAC (International Union of Pure and Applied Chemistry) or the CAS (Chemical Abstract Service) Registry number. Reference to applicable material standards may also be useful in this description.
If applicable, indication of biological material or derivate used in the medical device, including: origin (human, animal, recombinant or fermentation products or any other biological material), source (e.g. blood, bone, heart, any other tissue or cells), and the intended reason for its presence and, if applicable, its primary mode of action.
If the device contains an active pharmaceutical ingredient (API) or drug, an indication of the substance, should be provided. This should include its identity and source, and the intended reason for its presence and its primary mode of action.
Note: The sponsor/applicant should explicitly address any existing regional regulatory guidance related to the comprehensive device description and principles of operations provided in this section regarding the subject device.

Health Canada guidance

For devices containing an active pharmaceutical ingredient (API) or drug, refer to Health Canada policies about the classification of combination products can be found on the Health Canada website (e.g. Policy on Drug/Medical Device Combination Products - Decisions and Drug/Medical Device Combination Products).

Classification

New and amendment applications:

Required

2.04.02 - Description of Device Packaging

Folder name: 2.04.02-Description of Device Packaging

IMDRF common content

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

Health Canada guidance

Packaging of the device (or its components, if any) should be described including the materials employed. It should be clear what protective characteristics the packaging provides (e.g., maintains sterility, humidity, light sensitivity, transportation protection, etc.).

Classification

New licence applications:

Required

Amendment licence applications:

Conditionally required - Required if there have been changes in the packaging since the previous submission, or if the packaging is relevant to the submission (e.g. there has been a change in shelf-life or sterilization methods)

2.04.03 - History of Development

Folder name: 2.04.03-History of Development

IMDRF common content

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

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

Classification

New and amendment applications:

Required

2.04.04 - Reference and Comparison to Similar and/or Previous Generations of the Device

Folder name: 2.04.04-Ref-Comparison to Similar and-or Previous Gen

IMDRF common content

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

IMDRF Health Canada content

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

Classification

New and amendment applications:

Required

2.05 - Indications for Use and/or Intended Use and Contraindications

Folder name: 2.05-Indications-Intended Use-Contraindications

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

Classification

New and amendment applications:

Required

2.05.01 - Intended Use; Intended Purpose; Intended User; Indications for Use

Folder name: 2.05.01-Intended Use and Indications

IMDRF common content

This section should include, as appropriate:

Intended Use: The statement of intended use should specify the therapeutic or diagnostic function provided by the device and may describe the medical procedure in which the device is to be used (e.g. Diagnosis in vivo or in vitro, treatment monitoring rehabilitation, contraception, disinfection).
Intended Purpose: What is expected with the use of this medical device? Which results are expected?
Intended user and skills/knowledge/training that the user should have to operate or use the device.
Identify if the device is intended for single or multiple use
Indications for Use:
1. Disease or medical condition that the device will diagnose, treat, prevent, mitigate, or cure, parameters to be monitored and other considerations related to indication for use.
2. If applicable, information about patient selection criteria.
3. If applicable, information about intended patient population (e.g. adults, pediatrics or newborn) or a statement that no subpopulations exist for the disease or condition for which the device is intended.

Note:

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

Classification

New and amendment applications:

Required

2.05.02 - Intended Environment/Setting for use

Folder name: 2.05.02-Intended Environment-Setting

IMDRF common content

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

Classification

New and amendment applications:

Required

2.05.04 - Contraindications for Use

Folder name: 2.05.04-Contraindications

IMDRF common content

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

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

Classification

New and amendment applications:

Required

2.06 - Global Market History

Folder name: 2.06-Global Market History

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

Classification

New and amendment applications:

Required

2.06.01 - Global Market History

Folder name: 2.06.01-Global Market History

IMDRF common content

Up to date indication of the markets (all countries or jurisdictions) where the device is approved for marketing, including any marketing under compassionate use regulations.
Should include history of the marketing of the device by any other entity in as much detail as possible, acknowledging that detailed information may not be available in all cases.
If the subject device is different in any way (e.g. design, labelling, specifications) from those approved or marketed in other jurisdiction, the differences should be described.
The month and year of market approval in each country or jurisdiction where the device is marketed. If the device has been marketed for greater than 10 years, a statement of greater than 10 years can be made.
For each of the markets listed in (a) above, and statement of the commercial names used in those markets OR a clear statement that the commercial names are the same in all jurisdictions.
State the date of data capture for the market history data
If the subject device has been the subject of any previous compassionate use and/or clinical trials this should be identified and, if applicable, relevant reference numbers provided.

IMDRF Health Canada content

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

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

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

Classification

New and amendment applications:

Required

2.06.02 - Global Incident Reports and Recalls

Folder name: 2.06.02-Global Incident Reports-Recalls

IMDRF common content

List adverse events/incidents associated with the device and a statement of the period associated with this data.

If the number of adverse events is voluminous, provide a summary by event type that state the number of reported events for each event type.
List of the medical device recalls and/or advisory notice, and a discussion of the handling and solution given by the manufacturer in each case.
A description of any analysis and/or corrective actions undertaken in response to items listed above.

Note:

It is acknowledged that the definition of recall may vary from one jurisdiction to another; hence this heading is labelled as regionally focused (RF).

IMDRF Health Canada content

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

Classification

New and amendment applications:

Required

2.06.03 - Sales, Incident and Recall Rates

Folder name: 2.06.03-Sales Incident-Recall Rates

IMDRF common content

A summary of the number of units sold in each country/region and a statement of the period associated with this data.
Provide the rates calculated for each country/region, for example:
1. Incident rate = # adverse events or incidents divided by # units sold x 100
2. Recall rate = # recalls divided by # units sold x 100
Rates may be presented in other appropriate units such as per patient year of use or per use. In this case, methods for determining these rates should be presented and any assumptions supported.
Critical analyses of the rates calculated (e.g. Why are they acceptable? How do they break down in terms of incidents? Is there some outlier data that has driven the rates up? Are there any trends associated with any sub-groups of the devices that are subject of the submission (e.g. size, version)?).

Note:

It is acknowledged that the definition of recall may vary from one jurisdiction to another; hence this heading is labelled as regionally focused (RF).
Sales in this context should be reported as the number of units sold.
The summary of sales should be broken down by components when appropriate.

Classification

New and amendment applications:

Required

2.07 - Other Submission Context Information

Folder name: 2.07-Other Submission Context Info

IMDRF common content

To inform special/additional data that do not fit on previous headings.

Note: To ensure all elements of your submission are adequately reviewed, please be sure that any content placed here does not belong under any heading described above.

Classification

New and amendment applications:

Conditionally required - When information is requested by the regulator (through guidance documents or other communication) but does not belong in any of the other headings of this Chapter

3 - Non-Clinical Evidence

Folder name: 3-NON-CLIN

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

3.04 - Standards

Folder name: 3.04-Standards

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

Classification

New and amendment applications:

Conditionally required - If any sub-headings are required.

3.04.01 - List of Standards

Folder name: 3.04.01-List of Standards

IMDRF common content

List the standards that have been complied with in full or in part in the design and manufacture of the device.
At a minimum should include the standard organization, standard number, standard title, year/version, and if full or partial compliance.
If partial compliance, a list the sections of standard that
1. Are not applicable to the device, and/or
2. have been adapted, and/or
3. were deviated from for other reasons – discussion to accompany

Classification

New licence applications:

Conditionally required - If demonstrating that device complies with standards

Amendment licence applications:

Conditionally required - Required if there are standards that have been applied in relation to the amendment.

3.04.02 - Declaration and/or Certification of Conformity

Folder name: 3.04.02-Declaration and-or Certification of Conformity

IMDRF Health Canada content

The applicant is advised to prepare the Declaration of Conformity to recognized standards using Health Canada's Declaration of Conformity form. Refer to the Guidance Document: Recognition and Use of Standards under the Medical Devices Regulations and the current list of recognized standards for medical devices.

Classification

New licence applications:

Conditionally required - If demonstrating that device complies with standards

Amendment licence applications:

Conditionally required - Required if declaration of conformity is being made relating to standards relevant to the amendment.

3.05 - Non-clinical Studies

Folder name: 3.05-Studies

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

Classification

New licence applications:

Required

Amendment licence applications:

Conditionally required - If any sub-headings are required.

3.05.01 - Physical and Mechanical Characterization

Folder name: 3.05.01-Physical-Mechanical

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

Classifications

Refer to folder "3.05.01.00 - Overview" below for classification information.

3.05.01.00 - Overview

Folder name: 3.05.01.00-Overview

IMDRF common content

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

A summary of the non-clinical evidence that falls within this category
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 (i.e. what tests were considered and why they were or were not performed)
Discussion to support why the evidence presented is sufficient to support the application.
OR
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.

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 judgement 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-Study Title, Identifier, Date (see below)

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 files, specifically 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 files are to be named to ensure the sequence remains as described in the IMDRF ToC (i.e. Summary/Synopsis first followed by the Full Report second).

Further, as described in the Health Canada Adapted Assembly and Technical Guide for IMDRF Table of Contents Submissions 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:

A custom folder named "3.5.01.01-Component A Fatigue Test, MT4203, 2012-03-20" containing:

1-MT4203Summ.pdf
2-MT4203Report.pdf

and a custom folder named "3.5.01.02-Assembly B Wear Testing, MT4584, 2012-04-12" containing:

1-MT4584Summ.pdf
2-MT4584Report.pdf

Refer to the Main IMDRF ToC Implementation page for the definition of summary that describes summary content.

Custom Folder Classification

New and amendment applications:

Conditionally required - This is required for each study/test presented in this section.

Summary File Classification

New and amendment applications:

Conditionally required - A comprehensive summary is required for each study/test presented in this section. The test summary should be sufficiently detailed to stand alone in describing the evidence.

Report File Classification

New and amendment applications:

Optional

3.05.02 - Chemical/Material Characterization

Folder name: 3.05.02-Chemical-Material

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

Classifications

Refer to folder "3.05.02.00 - Overview" below for classification information.

3.05.02.00 - Overview

Folder name: 3.05.02.00-Overview

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:

A summary of the non-clinical evidence that falls within this category
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 (i.e. what tests were considered and why they were or were not performed)
Discussion to support why the evidence presented is sufficient to support the application.
OR
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.

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 judgement 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-Study Title, Identifier, Date (see below)

Health Canada guidance

For example, when a fatigue test and wear test are being included, the application would include:

A custom folder named "3.5.01.01-Component A Fatigue Test, MT4203, 2012-03-20" containing:

1-MT4203Summ.pdf
2-MT4203Report.pdf

and a custom folder named "3.5.01.02-Assembly B Wear Testing, MT4584, 2012-04-12" containing:

1-MT4584Summ.pdf
2-MT4584Report.pdf

Refer to the Main IMDRF ToC Implementation page for the definition of summary that describes summary content.

Custom Folder Classification

New and amendment applications:

Conditionally required - This is required for each study/test presented in this section.

Summary File Classification

New and amendment applications:

Conditionally required - A comprehensive summary is required for each study/test presented in this section. The test summary should be sufficiently detailed to stand alone in describing the evidence.

Report File Classification

New and amendment applications:

Optional

3.05.03 - Electrical Systems: Safety, Mechanical and Environmental Protection, and Electromagnetic Compatibility

Folder name: 3.05.03-Electrical Systems

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

Classifications

Refer to folder "3.05.03.00 - Overview" below for classification information.

3.05.03.00 - Overview

Folder name: 3.05.03.00-Overview

IMDRF common content

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

A summary of the non-clinical evidence that falls within this category
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 (i.e. what tests were considered and why they were or were not performed)
Discussion to support why the evidence presented is sufficient to support the application.
OR
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 the Medical Devices Bureau does not mean that the licenced device has been assessed to meet all relevant regulations – only 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 necessary national or provincial regulations applicable to their product.

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 judgement is required 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-Study Title, Identifier, Date (see below)

Health Canada guidance

For example, when a fatigue test and wear test are being included, the application would include:

A custom folder named "3.5.01.01-Component A Fatigue Test, MT4203, 2012-03-20" containing:

1-MT4203Summ.pdf
2-MT4203Report.pdf

and a custom folder named "3.5.01.02-Assembly B Wear Testing, MT4584, 2012-04-12" containing:

1-MT4584Summ.pdf
2-MT4584Report.pdf

Refer to the Main IMDRF ToC Implementation page for the definition of summary that describes summary content.

Custom Folder Classification

New and amendment applications:

Conditionally required - This is required for each study/test presented in this section.

Summary File Classification

New and amendment applications:

Conditionally required - A comprehensive summary is required for each study/test presented in this section. The test summary should be sufficiently detailed to stand alone in describing the evidence.

Report File Classification

New and amendment applications:

Optional

3.05.04 - Radiation Safety

Folder name: 3.05.04-Radiation Safety

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

Classifications

Refer to folder "3.05.04.00 - Overview" below for classification information.

3.05.04.00 - Overview

Folder name: 3.05.04.00-Overview

IMDRF common content

Studies supporting radiation safety, where the device emits radiation or where the device is exposed to radiation are to be included in this section. This should include:

A summary of the non-clinical evidence that falls within this category
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 (i.e. what tests were considered and why they were or were not performed)
Discussion to support why the evidence presented is sufficient to support the application.
OR
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 onus is on manufacturers of radiation emitting medical devices to ensure that their devices meet all of the necessary national or provincial regulations applicable to their product.

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 judgement is required 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-Study Title, Identifier, Date (see below)

Health Canada guidance

For example, when a fatigue test and wear test are being included, the application would include:

A custom folder named "3.5.01.01-Component A Fatigue Test, MT4203, 2012-03-20" containing:

1-MT4203Summ.pdf
2-MT4203Report.pdf

and a custom folder named "3.5.01.02-Assembly B Wear Testing, MT4584, 2012-04-12" containing:

1-MT4584Summ.pdf
2-MT4584Report.pdf

Refer to the Main IMDRF ToC Implementation page for the definition of summary that describes summary content.

Custom Folder Classification

New and amendment applications:

Conditionally required - This is required for each study/test presented in this section.

Summary File Classification

New and amendment applications:

Conditionally required - A comprehensive summary is required for each study/test presented in this section. The test summary should be sufficiently detailed to stand alone in describing the evidence.

Report File Classification

New and amendment applications:

Optional

3.05.05 - Software/Firmware

Folder name: 3.05.05-Software-Firmware

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

Classification

New and amendment applications:

Conditionally required - Not required when this type of evidence/testing is clearly not applicable to the device or submission.

3.05.05.01 - Software/Firmware Description

Folder name: 3.05.05.01-Description

IMDRF common content

Specify the name of the software
Specify 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.
Provide a description of the software including the 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.
Provide a statement about software version naming rules, specify all fields and their meanings of software version, and determine the complete version of software and its identification version used for release.

IMDRF Health Canada content

The level of concern associated with the software stated and supported.

Health Canada guidance

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

If the software or a previous version of the software has been reviewed by Health Canada, this should be clearly stated and appropriate references provided (e.g. application and/or licence number).

Classification

New and amendment applications:

Conditionally required - This is required if the device includes software.

3.05.05.02 - Hazard Analysis

Folder name: 3.05.05.02-Hazard Analysis

IMDRF common content

The Hazard Analysis should take into account all device hazards associated with the device's intended use, including both hardware and software hazards.

Note:

This document can be in the form of an extract of the software-related items from comprehensive risk management documentation, described in ISO 14971.
Hazard analysis, should address all foreseeable hazards, including those resulting from intentional or inadvertent misuse of the device.

Classification

New licence applications:

Conditionally required - This is required if the device includes software.

Amendment licence applications:

Conditionally required - When relevant to the amendment

3.05.05.03 - Software Requirement Specification

Folder name: 3.05.05.03-SRS

IMDRF common content

The Software Requirements Specification (SRS) documents the requirements for the software. This typically includes functional, performance, interface, design, developmental, and other requirements for the software. In effect, this document describes what the Software Device is supposed to do. For example, hardware requirements, programming language requirement, interface requirements, performance and functional requirements.

Classification

New licence applications:

Conditionally required - This is required if the device includes software.

Amendment licence applications:

Conditionally required - When relevant to the amendment

3.05.05.04 - Architecture Design Chart

Folder name: 3.05.05.04-Architecture

IMDRF common content

Detailed depiction of functional units and software modules. May include state diagrams as well as flow charts.

Classification

New licence applications:

Conditionally required - This is required if the device includes software.

Amendment licence applications:

Conditionally required - When relevant to the amendment

3.05.05.05 - Software Design Specification

Folder name: 3.05.05.05-SDS

IMDRF common content

The Software Design Specification (SDS) describes the implementation of the requirements for the Software Device. The SDS describes how the requirements in the SRS are implemented.

Classification

New licence applications:

Conditionally required - This is required if the device includes software.

Amendment licence applications:

Conditionally required - When relevant to the amendment

3.05.05.06 - Traceability Analysis

Folder name: 3.05.05.06-Traceability Analysis

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.

Classification

New licence applications:

Conditionally required - This is required if the device includes software.

Amendment licence applications:

Conditionally required - When relevant to the amendment

3.05.05.07 - Software Development Environment Description

Folder name: 3.05.05.07-Softw Life Cycle Process Desc

IMDRF common content

A summary describing 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 - This is required if the device includes software.

Amendment licence applications:

Conditionally required - When relevant to the amendment

3.05.05.08 - Software Verification and Validation

Folder name: 3.05.05.08-Software V-V

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

Classifications

Refer to folder "3.05.05.08.00 - Overview" below for classification information.

3.05.05.08.00 - Overview

Folder name: 3.05.05.08.00-Overview

IMDRF common content

This heading should include:

An overview of all verification, validation and testing performed both in-house and in a simulated or actual user environment prior to final release.
Discussion to support why the evidence presented is sufficient to support the application.
OR
A statement of why this category of non-clinical laboratory study is not applicable to this case.

Note:

Discussion should address all of the different hardware configurations and, where applicable, operating systems identified in the labelling.
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

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 judgement is required 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-Study Title, Identifier, Date (see below)

Health Canada guidance

For example, when a fatigue test and wear test are being included, the application would include:

A custom folder named "3.5.01.01-Component A Fatigue Test, MT4203, 2012-03-20" containing:

1-MT4203Summ.pdf
2-MT4203Report.pdf

and a custom folder named "3.5.01.02-Assembly B Wear Testing, MT4584, 2012-04-12" containing:

1-MT4584Summ.pdf
2-MT4584Report.pdf

Refer to the Main IMDRF ToC Implementation page for the definition of summary that describes summary content.

Custom Folder Classification

New and amendment applications:

Conditionally required - This is required for each study/test presented in this section.

Summary File Classification

New and amendment applications:

Conditionally required - A comprehensive summary is required for each study/test presented in this section. The test summary should be sufficiently detailed to stand alone in describing the evidence.

Report File Classification

New and amendment applications:

Optional

3.05.05.09 - Revision Level History

Folder name: 3.05.05.09-Revision Level History

IMDRF common content

Revision history log, including release version number and date.

Classification

New licence applications:

Conditionally required - When software is part of the device.

Amendment licence applications:

Conditionally required - When relevant to the amendment

3.05.05.10 - Unresolved Anomalies (Bugs or Defects)

Folder name: 3.05.05.10-Unresolved Anomalies

IMDRF common content

All unresolved anomalies in the release version of the software should be summarized, along with a justification for acceptability (i.e. the problem, impact on safety and effectiveness, and any plans for correction of the problems).

Classification

New licence applications:

Conditionally required - When software is part of the device.

Amendment licence applications:

Conditionally required - When relevant to the amendment

3.05.05.11 - Cybersecurity

Folder name: 3.05.05.11-Cybersecurity

IMDRF common content

Evidence to support the cybersecurity should be provided here. For example, but not limited to:

Cybersecurity vulnerabilities and risks analysis
Cybersecurity controls measures
Traceability matrix linking cybersecurity controls to the cybersecurity vulnerabilities and risks

Classification

New licence applications:

Conditionally required - When the results of a risk assessment suggest that there are safety and effectiveness concerns relating to cybersecurity of the device, this is required.

Amendment licence applications:

Conditionally required - When relevant to the amendment

3.05.05.12 - Interoperability

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, this is required.

Amendment licence applications:

Conditionally required - When relevant to the amendment

3.05.06 - Biocompatibility and Toxicology Evaluation

Folder name: 3.05.06-Biocomp-Toxicology

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

Classifications

Refer to folder "3.05.06.00 - Overview" below for classification information.

3.05.06.00 - Overview

Folder name: 3.05.06.00-Overview

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:

A list of all materials in direct or indirect contact with the patient or user.
State conducted tests, applied standards, test protocols, the analysis of data and the summary of results
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 (i.e. what tests were considered and why they were or were not performed)
Discussion to support why the evidence presented is sufficient to support the application.
OR
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
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 which are potentially patient contacting is required. Tests should be conducted on samples from the final product after all manufacturing and processing has been completed (e.g., 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 a summary of the results and conclusions drawn. 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, a summary of the results as well as the conclusion must also be provided (e.g., cytotoxicity testing found mild toxicity (average score 1) for patient contacting material, therefore device is considered biocompatible for intended use).

MSDS are not sufficient to demonstrate biocompatibility.

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 judgement is required 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-Study Title, Identifier, Date (see below)

Health Canada guidance

For example, when a fatigue test and wear test are being included, the application would include:

A custom folder named "3.5.01.01-Component A Fatigue Test, MT4203, 2012-03-20" containing:

1-MT4203Summ.pdf
2-MT4203Report.pdf

and a custom folder named "3.5.01.02-Assembly B Wear Testing, MT4584, 2012-04-12" containing:

1-MT4584Summ.pdf
2-MT4584Report.pdf

Refer to the Main IMDRF ToC Implementation page for the definition of summary that describes summary content.

Custom Folder Classification

New and amendment applications:

Conditionally required - This is required for each study/test presented in this section.

Summary File Classification

New and amendment applications:

Conditionally required - A comprehensive summary is required for each study/test presented in this section. The test summary should be sufficiently detailed to stand alone in describing the evidence.

Report File Classification

New and amendment applications:

Optional

3.05.07 - Non-Material-Mediated Pyrogenicity

Folder name: 3.05.07-Pyrogenicity

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

Classifications

Refer to folder "3.05.07.00 - Overview" below for classification information.

3.05.07.00 - Overview

Folder name: 3.05.07.00-Overview

IMDRF common content

Studies to support pyrogenicity evaluation of final release are to be included in this section. This should include:

A summary of the non-clinical evidence that falls within this category
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 (i.e. what tests were considered and why they were or were not performed)
Discussion to support why the evidence presented is sufficient to support the application.
OR
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 (i.e., acute, subacute or subchronic), pyrogen test data and methods should also be summarized and should cover frequency of testing, number of units tested, methods of testing, any deviations from this testing, and test results.

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 judgement is required 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]

Folder name: 3.05.07.01-Study Title, Identifier, Date (see below)

Health Canada guidance

For example, when a fatigue test and wear test are being included, the application would include:

A custom folder named "3.5.01.01-Component A Fatigue Test, MT4203, 2012-03-20" containing:

1-MT4203Summ.pdf
2-MT4203Report.pdf

and a custom folder named "3.5.01.02-Assembly B Wear Testing, MT4584, 2012-04-12" containing:

1-MT4584Summ.pdf
2-MT4584Report.pdf

Refer to the Main IMDRF ToC Implementation page for the definition of summary that describes summary content.

Custom Folder Classification

New and amendment applications:

Conditionally required - This is required for each study/test presented in this section.

Summary File Classification

New and amendment applications:

Conditionally required - A comprehensive summary is required for each study/test presented in this section. The test summary should be sufficiently detailed to stand alone in describing the evidence.

Report File Classification

New and amendment applications:

Optional

3.05.08 - Safety of Materials of Biological Origin (human/animal)

Folder name: 3.05.08-Bio Material Safety

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

Classifications

Refer to folder "3.05.08.00 - Overview" below for classification information.

3.05.08.00 - Overview

Folder name: 3.05.08.00-Overview

IMDRF common content

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

A description of biological material or derivate
State the harvesting, processing, preservation, testing and handling of tissues, cells and substances
If applicable, discussion of infectious agents/transmissible agents known to infect the source animal
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.
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.
The system for recordkeeping to allow traceability from sources to the finished device should be fully described
Discussion to support why the evidence presented is sufficient to support the application.
OR
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

This section is applicable to all medical devices which are manufactured from or incorporate biological material from human, animal or microbial origin. If the only biological materials are heparin or tallow derivatives (e.g., glycerol) this in itself does not change the classification of the device to class IV.
Additional classification guidance can be sought through the Medical Devices Bureau.

The detailed information expected for each material depends on the type of biological material and the particular risks inherent in that particular material. Some guidance can be found below.

The following information should be provided, as applicable, relating to animal tissues that are incorporated into the device:

Tissue type;
Animal species;
Certification of country of origin/residence of animal;
Name and address of the supplier of any animal material;
Certificate of veterinary inspection;
Certificate of abattoir inspection;
Certification that the animal was fit for human consumption;
Details relating to collecting, handling, storing and transporting of the tissue;
Discussion of infectious agents/transmissible agents known to infect the source animal.

Evidence should be presented that demonstrates: i) a system is in place for animals and tissue traceability; and ii) quality control processes and procedures are in place to prevent contamination with potential infectious/transmissible agents, including Transmissible Spongiform Encephalopathies (TSEs).

Disinfection/decontamination procedures in the event of contamination should also be outlined along with appropriate validation.

Process validation results should be included to substantiate that manufacturing procedures are in place to minimize biological risks in particular, with regard to viruses and other transmissible agents. If claims are made concerning removal/inactivation of TSEs, the details of these studies must be provided. The ICH Q5A which has been adopted by the Therapeutic Products Directorate can be consulted for guidance on viral inactivation validation.

An assessment of other applicable hazards such as those associated with the local host response to the animal material (biocompatibility) including pyrogenic, immunological or toxicological responses should be provided.

Medical devices incorporating tissues of human origin pose a special risk for both patients and health care providers. Reported incidents of pathogen transmission via these types of medical devices have resulted in a heightened awareness of the need for rules governing material selection, harvesting, processing and use.

Medical devices which incorporate viable and non-viable human tissues which have undergone more than minimal manipulation will continue to be regulated under the Medical Devices Regulations as Class IV devices. It has been determined that any product that is minimally manipulated cannot be a medical device. A definition of minimally manipulated can be found in the Safety of Human Cells, Tissues and Organs for Transplantation Regulations (CTO Regulations).

Currently, cryopreserved heart valves and human harvested dura mater are medical devices which incorporate viable and non-viable human tissues which have undergone “minimal manipulation”. These products have been regulated as medical devices due to exceptional potential risks. It is the intention to move these to the CTO regulatory regime in the future.

The manufacturing information should include the donor screening and testing procedures (screening assays used must be licensed in Canada), procurement and processing processes, controls placed on the transportation of tissues and their derivatives, and the method of tracking employed. Infection control procedures must also be fully described and take into consideration the potential infectivity of the materials involved.

Recombinant and fermentation products may form part of a medical device. Usually these products on their own are classified as biologicals and regulated by BGTD. Cell lines used in the production of material for medical devices must be fully characterized and tested for the absence of undesirable viruses which may be infectious and/or pathogenic for humans.

It is recognized that some cell lines, especially those from rodents, used for the manufacture of products will contain endogenous retroviruses, retrovirus particles or retrovirus-like particles. In this case, the capacity of the manufacturing process to remove and/or inactivate these retroviruses from the product should be demonstrated. The ICH guideline on Biotechnology Products adopted by the Health Canada should be consulted for guidance on how this viral validation should be conducted.

A complete characterization of the expressed material(s) and carrier should be provided including such information as: 1) full physical/chemical/biochemical characterization of the peptides/proteins using analysis including mapping of the expressed peptide/protein and/or the carrier if applicable, SDS-PAGE, cation exchange, chromatography, 2D-gel electrophoresis and HPLC; 2) device activity bioassays in vivo and in vitro 3) studies of the pharmacokinetics, biodistribution and systemic effects of the expressed agent; and 4) complete sterilization and stability information.

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 judgement is required to justify why no information is required, then the heading is considered required and the justification should be provided.

3.05.08.01 - Certificates

Folder name: 3.05.08.01-Certificates

IMDRF common content

Certificates that support the safety of materials of biological origin (e.g. certificate of abattoir inspection).

Classification

New licence applications:

Conditionally required - When material of biological material is included in the device that requires support with certificates associated with this material.

Amendment licence applications:

Conditionally required - When applicable to submission.

3.05.08.02 - [Study description, study identifier, date of initiation]

Folder name: 3.05.08.02-Study Title, Identifier, Date (see below)

Health Canada guidance

For example, when a fatigue test and wear test are being included, the application would include:

A custom folder named "3.5.01.01-Component A Fatigue Test, MT4203, 2012-03-20" containing:

1-MT4203Summ.pdf
2-MT4203Report.pdf

and a custom folder named "3.5.01.02-Assembly B Wear Testing, MT4584, 2012-04-12" containing:

1-MT4584Summ.pdf
2-MT4584Report.pdf

Refer to the Main IMDRF ToC Implementation page for the definition of summary that describes summary content.

Custom Folder Classification

New and amendment applications:

Conditionally required - This is required for each study/test presented in this section.

Summary File Classification

New and amendment applications:

Conditionally required - A comprehensive summary is required for each study/test presented in this section. The test summary should be sufficiently detailed to stand alone in describing the evidence.

Report File Classification

New and amendment applications:

Optional

3.05.09 - Sterilization Validation

Folder name: 3.05.09-Sterility

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

Classification

New and amendment applications:

Conditionally required - If any sub-headings are required.

3.05.09.01 - End-User Sterilization

Folder name: 3.05.09.01-End-User

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

Classifications

Refer to folder "3.05.09.01.00 - Overview" below for classification information.

3.05.09.01.00 - Overview

Folder name: 3.05.09.01.00-Overview

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:

A description of the sterilization process (method, parameters)
A summary of the non-clinical evidence that falls within this category
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 (i.e. what tests were considered and why they were or were not performed)
If applicable, state the rationale on the durability of the product against two or more sterilization.
Discussion to support why the evidence presented is sufficient to support the application.
OR
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.

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 judgement 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-Study Title, Identifier, Date (see below)

Health Canada guidance

For example, when a fatigue test and wear test are being included, the application would include:

A custom folder named "3.5.01.01-Component A Fatigue Test, MT4203, 2012-03-20" containing:

1-MT4203Summ.pdf
2-MT4203Report.pdf

and a custom folder named "3.5.01.02-Assembly B Wear Testing, MT4584, 2012-04-12" containing:

1-MT4584Summ.pdf
2-MT4584Report.pdf

Refer to the Main IMDRF ToC Implementation page for the definition of summary that describes summary content.

Custom Folder Classification

New and amendment applications:

Conditionally required - This is required for each study/test presented in this section.

Summary File Classification

New and amendment applications:

Conditionally required - A comprehensive summary is required for each study/test presented in this section. The test summary should be sufficiently detailed to stand alone in describing the evidence.

Report File Classification

New and amendment applications:

Optional

3.05.09.02 - Manufacturer Sterilization

Folder name: 3.05.09.02-Manufacturer

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

Classifications

Refer to folder "3.05.09.02.00 - Overview" below for classification information.

3.05.09.02.00 - Overview

Folder name: 3.05.09.02.00-Overview

IMDRF common content

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

A description of the sterilization process (method, parameters) and Sterility Assurance Level (SAL)
State if parametric release is used
A summary of the non-clinical evidence that falls within this category
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.
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 (i.e. what tests were considered and why they were or were not performed)
Discussion to support why the evidence presented is sufficient to support the application.
OR
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 needs to be described and rationalized (e.g.,"most difficult to sterilize" location). If a group of devices are 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.

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 judgement 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-Study Title, Identifier, Date (see below)

Health Canada guidance

For example, when a fatigue test and wear test are being included, the application would include:

A custom folder named "3.5.01.01-Component A Fatigue Test, MT4203, 2012-03-20" containing:

1-MT4203Summ.pdf
2-MT4203Report.pdf

and a custom folder named "3.5.01.02-Assembly B Wear Testing, MT4584, 2012-04-12" containing:

1-MT4584Summ.pdf
2-MT4584Report.pdf

Refer to the Main IMDRF ToC Implementation page for the definition of summary that describes summary content.

Custom Folder Classification

New and amendment applications:

Conditionally required - This is required for each study/test presented in this section.

Summary File Classification

New and amendment applications:

Conditionally required - A comprehensive summary is required for each study/test presented in this section. The test summary should be sufficiently detailed to stand alone in describing the evidence.

Report File Classification

New and amendment applications:

Optional

3.05.09.03 - Residual Toxicity

Folder name: 3.05.09.03-Residual Tox

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

Classifications

Refer to folder "3.05.09.03.00 - Overview" below for classification information.

3.05.09.03.00 - Overview

Folder name: 3.05.09.03.00-Overview

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:

A summary of the non-clinical evidence that falls within this category
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 (i.e. what tests were considered and why they were or were not performed)
Discussion to support why the evidence presented is sufficient to support the application.
OR
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

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

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 judgement 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-Study Title, Identifier, Date (see below)

Health Canada guidance

For example, when a fatigue test and wear test are being included, the application would include:

A custom folder named "3.5.01.01-Component A Fatigue Test, MT4203, 2012-03-20" containing:

1-MT4203Summ.pdf
2-MT4203Report.pdf

and a custom folder named "3.5.01.02-Assembly B Wear Testing, MT4584, 2012-04-12" containing:

1-MT4584Summ.pdf
2-MT4584Report.pdf

Refer to the Main IMDRF ToC Implementation page for the definition of summary that describes summary content.

Custom Folder Classification

New and amendment applications:

Conditionally required - This is required for each study/test presented in this section.

Summary File Classification

New and amendment applications:

Conditionally required - A comprehensive summary is required for each study/test presented in this section. The test summary should be sufficiently detailed to stand alone in describing the evidence.

Report File Classification

New and amendment applications:

Optional

3.05.09.04 - Cleaning and Disinfection Validation

Folder name: 3.05.09.04-Clean-Disinfect Val

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

Classifications

Refer to folder "3.05.09.04.00 - Overview" below for classification information.

3.05.09.04.00 - Overview

Folder name: 3.05.09.04.00-Overview

IMDRF common content

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

A summary of the non-clinical evidence that falls within this category
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 (i.e. what tests were considered and why they were or were not performed)
Discussion to support why the evidence presented is sufficient to support the application.
OR
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.

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 judgement is required 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-Study Title, Identifier, Date (see below)

Health Canada guidance

For example, when a fatigue test and wear test are being included, the application would include:

A custom folder named "3.5.01.01-Component A Fatigue Test, MT4203, 2012-03-20" containing:

1-MT4203Summ.pdf
2-MT4203Report.pdf

and a custom folder named "3.5.01.02-Assembly B Wear Testing, MT4584, 2012-04-12" containing:

1-MT4584Summ.pdf
2-MT4584Report.pdf

Refer to the Main IMDRF ToC Implementation page for the definition of summary that describes summary content.

Custom Folder Classification

New and amendment applications:

Conditionally required - This is required for each study/test presented in this section.

Summary File Classification

New and amendment applications:

Conditionally required - A comprehensive summary is required for each study/test presented in this section. The test summary should be sufficiently detailed to stand alone in describing the evidence.

Report File Classification

New and amendment applications:

Optional

3.05.09.05 - Reprocessing of Single Use Devices Validation Data

Folder name: 3.05.09.05-Reprocessing of SUDs

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

Classifications

Refer to folder "3.05.09.05.00 - Overview" below for classification information.

3.05.09.05.00 - Overview

Folder name: 3.05.09.05.00-Overview

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.

Classification

New and amendment applications:

Conditionally required - 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-Study Title, Identifier, Date (see below)

Health Canada guidance

For example, when a fatigue test and wear test are being included, the application would include:

A custom folder named "3.5.01.01-Component A Fatigue Test, MT4203, 2012-03-20" containing:

1-MT4203Summ.pdf
2-MT4203Report.pdf

and a custom folder named "3.5.01.02-Assembly B Wear Testing, MT4584, 2012-04-12" containing:

1-MT4584Summ.pdf
2-MT4584Report.pdf

Refer to the Main IMDRF ToC Implementation page for the definition of summary that describes summary content.

Custom Folder Classification

New and amendment applications:

Conditionally required - This is required for each study/test presented in this section.

Summary File Classification

New and amendment applications:

Conditionally required - A comprehensive summary is required for each study/test presented in this section. The test summary should be sufficiently detailed to stand alone in describing the evidence.

Report File Classification

New and amendment applications:

Optional

3.05.10 - Animal Testing

Folder name: 3.05.10-Animal Testing

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

Classifications

Refer to folder "3.05.10.00 - Overview" below for classification information.

3.05.10.00 - Overview

Folder name: 3.05.10.00-Overview

IMDRF common content

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

A summary of the non-clinical evidence that falls within this category
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 (i.e. what tests were considered and why they were or were not performed)
Discussion to support why the evidence presented is sufficient to support the application.
OR
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(s). The rationale (and limitations) of selecting the particular animal model should be discussed.

This section should not include animal studies supporting biocompatibility.

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 judgement is required 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]

Folder name: 3.05.10.01-Study Title, Identifier, Date (see below)

Health Canada guidance

For example, when a fatigue test and wear test are being included, the application would include:

A custom folder named "3.5.01.01-Component A Fatigue Test, MT4203, 2012-03-20" containing:

1-MT4203Summ.pdf
2-MT4203Report.pdf

and a custom folder named "3.5.01.02-Assembly B Wear Testing, MT4584, 2012-04-12" containing:

1-MT4584Summ.pdf
2-MT4584Report.pdf

Refer to the Main IMDRF ToC Implementation page for the definition of summary that describes summary content.

Custom Folder Classification

New and amendment applications:

Conditionally required - This is required for each study/test presented in this section.

Summary File Classification

New and amendment applications:

Conditionally required - A comprehensive summary is required for each study/test presented in this section. The test summary should be sufficiently detailed to stand alone in describing the evidence.

Report File Classification

New and amendment applications:

Optional

3.05.11 - Usability/Human Factors

Folder name: 3.05.11-Usability-Human Factors

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

Classifications

Refer to folder "3.05.11.00 - Overview" below for classification information.

3.05.11.00 - Overview

Folder name: 3.05.11.00-Overview

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:

A summary of the non-clinical evidence that falls within this category
A statement of the test environment and relation to the intended use environment
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 (i.e. what tests were considered and why they were or were not performed)
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.
Discussion to support why the evidence presented is sufficient to support the application.
OR
A statement of why this category of non-clinical laboratory study is not applicable to this case.

Note:

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.
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.

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 judgement is required 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-Study Title, Identifier, Date (see below)

Health Canada guidance

For example, when a fatigue test and wear test are being included, the application would include:

A custom folder named "3.5.01.01-Component A Fatigue Test, MT4203, 2012-03-20" containing:

1-MT4203Summ.pdf
2-MT4203Report.pdf

and a custom folder named "3.5.01.02-Assembly B Wear Testing, MT4584, 2012-04-12" containing:

1-MT4584Summ.pdf
2-MT4584Report.pdf

Refer to the Main IMDRF ToC Implementation page for the definition of summary that describes summary content.

Custom Folder Classification

New and amendment applications:

Conditionally required - This is required for each study/test presented in this section.

Summary File Classification

New and amendment applications:

Conditionally required - A comprehensive summary is required for each study/test presented in this section. The test summary should be sufficiently detailed to stand alone in describing the evidence.

Report File Classification

New and amendment applications:

Optional

3.06 - Non-clinical Bibliography

Folder name: 3.06-Non-Clin Bibliography

IMDRF common content

This heading should include:

A listing of published non-clinical studies involving this specific device (e.g. cadaveric evaluations, biomechanical assessments)
A legible copies of key articles , including translation where applicable to meet the regulators language requirements
Discussion to support why the evidence presented is sufficient to support the application.
OR
A statement that no literature related to the device was found.

Health Canada guidance

To facilitate the review process, the manufacturer should provide a bibliography (i.e. list of references) of all relevant published literature dealing with the use, safety and effectiveness and the indications for use of the subject device in question. If information within the article is being provided as key evidence of safety or effectiveness, a summary of the relevant sections should be provided including data upon which the conclusions are drawn. Copies of the articles should also be provided. Care should be taken to ensure that the references are timely and relevant to the current application. A bibliography may not be necessary if the device or its technology is well known with a long history of use.

Classification

New licence applications:

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

Amendment licence applications:

Conditionally required - When relevant to the amendment

3.07 - Expiration Period and Package Validation

Folder name: 3.07-Expiration Period-Package Val

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

Classifications

Refer to folder "3.07.00 - Overview" below for classification information.

3.07.00 - Overview

Folder name: 3.07.00-Overview

IMDRF common content

This heading should include:

An indication of environmental conditions for correct storage of the device (e.g. temperature, pressure, humidity, luminosity).
A statement of the expiration period considering the materials and sterilization (when applicable), indicated as a period of time or any other means of appropriate quantification.
OR
A rationale that storage conditions could not affect device safety or effectiveness

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 judgement is required to justify why no information is required, then the heading is considered required and the justification should be provided.

3.07.01 - Product Stability

Folder name: 3.07.01-Product Stability

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

Classifications

Refer to folder "3.07.01.00 - Overview" below for classification information.

3.07.01.00 - Overview

Folder name: 3.07.01.00-Overview

IMDRF common content

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

A summary of the non-clinical evidence that falls within this category
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 (i.e. what tests were considered and why they were or were not performed)
Discussion to support why the evidence presented is sufficient to support the application.
OR
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 (e.g. accelerated versus real time) should be provided along with the storage conditions used and the state of the product when tested (e.g. sterilized, production version, prototype, transportation, simulation, etc.). Devices containing materials of unknown stability should have real-time data.

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 judgement is required 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-Study Title, Identifier, Date (see below)

Health Canada guidance

For example, when a fatigue test and wear test are being included, the application would include:

A custom folder named "3.5.01.01-Component A Fatigue Test, MT4203, 2012-03-20" containing:

1-MT4203Summ.pdf
2-MT4203Report.pdf

and a custom folder named "3.5.01.02-Assembly B Wear Testing, MT4584, 2012-04-12" containing:

1-MT4584Summ.pdf
2-MT4584Report.pdf

Refer to the Main IMDRF ToC Implementation page for the definition of summary that describes summary content.

Custom Folder Classification

New and amendment applications:

Conditionally required - This is required for each study/test presented in this section.

Summary File Classification

New and amendment applications:

Conditionally required - A comprehensive summary is required for each study/test presented in this section. The test summary should be sufficiently detailed to stand alone in describing the evidence.

Report File Classification

New and amendment applications:

Optional

3.07.02 - Package Validation

Folder name: 3.07.02-Package Val

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

Classifications

Refer to folder "3.07.02.00 - Overview" below for classification information.

3.07.02.00 - Overview

Folder name: 3.07.02.00-Overview

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:

A summary of the non-clinical evidence that falls within this category
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 (i.e. what tests were considered and why they were or were not performed)
Discussion to support why the evidence presented is sufficient to support the application.
OR
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 (e.g., considerations related to sterility, humidity, light sensitivity, pressure or oxidative reaction under irradiation), evidence should be provided 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 (i.e., for claimed shelf life). In the case of sterility, ensure that the test methods address both seal integrity and sterility (e.g., bubble test, dye penetration test, etc.).

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 judgement is required 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-Study Title, Identifier, Date (see below)

Health Canada guidance

For example, when a fatigue test and wear test are being included, the application would include:

A custom folder named "3.5.01.01-Component A Fatigue Test, MT4203, 2012-03-20" containing:

1-MT4203Summ.pdf
2-MT4203Report.pdf

and a custom folder named "3.5.01.02-Assembly B Wear Testing, MT4584, 2012-04-12" containing:

1-MT4584Summ.pdf
2-MT4584Report.pdf

Refer to the Main IMDRF ToC Implementation page for the definition of summary that describes summary content.

Custom Folder Classification

New and amendment applications:

Conditionally required - This is required for each study/test presented in this section.

Summary File Classification

New and amendment applications:

Conditionally required - A comprehensive summary is required for each study/test presented in this section. The test summary should be sufficiently detailed to stand alone in describing the evidence.

Report File Classification

New and amendment applications:

Optional

3.08 - Other non-clinical Evidence

Folder name: 3.08-Other Non-Clin Evidence

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

Classifications

Refer to folder "3.08.00 - Overview" below for classification information.

3.08.00 - Overview

Folder name: 3.08.00-Overview

IMDRF common content

Heading for other information that may be important to the submission but that does not fit in any of the other headings of this chapter. This section is specifically intended for tests performed to ensure the safety and/or effectiveness of the device that are not delineated in the rest of the Chapter 3. This should include

A description of the purpose of the test, the risk/safety issue the test is addressing; the test methods and results of the test

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.

Classification

New and amendment applications:

Conditionally required - When information is requested by the regulator (through guidance documents or other communication) but does not belong in any of the other headings of this Chapter

3.08.01 - [Study description, study identifier, date of initiation]

Folder name: 3.08.01-Study Title, Identifier, Date (see below)

Health Canada guidance

For example, when a fatigue test and wear test are being included, the application would include:

A custom folder named "3.5.01.01-Component A Fatigue Test, MT4203, 2012-03-20" containing:

1-MT4203Summ.pdf
2-MT4203Report.pdf

and a custom folder named "3.5.01.02-Assembly B Wear Testing, MT4584, 2012-04-12" containing:

1-MT4584Summ.pdf
2-MT4584Report.pdf

Refer to the Main IMDRF ToC Implementation page for the definition of summary that describes summary content.

Custom Folder Classification

New and amendment applications:

Conditionally required - This is required for each study/test presented in this section.

Summary File Classification

New and amendment applications:

Conditionally required - A comprehensive summary is required for each study/test presented in this section. The test summary should be sufficiently detailed to stand alone in describing the evidence.

Report File Classification

New and amendment applications:

Optional

4 - Clinical Evidence

Folder name: 4-CLINICAL

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

4.02 - Overall Clinical Evidence Summary

Folder name: 4.02-Overall Clinical Evidence Summary

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

Classifications

Refer to folder "4.02.00 - Overview" below for classification information.

4.02.00 - Overview

Folder name: 4.02.00-Overview

IMDRF common content

This should be a brief (1-2 page) summary of the available clinical evidence being presented in support of the submission. The document should list the evidence presented, its characteristics (RCT, case study, literature review) and provide a discussion of how this is considered sufficient to support request for marketing for the requested indications. A tabular listing of clinical studies may be included in this section.
If any of the study devices differ from the devices to be marketed, including competitors devices, a description of these differences and their impact on the validity of the evidence in terms of support for the application.
A discussion of the clinical evidence considered for the device and support for their selection (i.e. what type of evidence was considered and why they were or were not used)
Discussion to support why the evidence presented is sufficient to support the application.

Note: Human factors testing that include patients should be included here.

IMDRF Health Canada content

Provide the Investigational Testing Authorization reference number for any clinical trials conducted under an Investigational Testing Authorization in Canada.
If applicable, provide the clinicaltrials.gov reference number for any clinical studies registered with clinicaltrials.gov.

Health Canada guidance

An evaluation of clinical evidence is necessary to help establish the clinical safety and effectiveness of a medical device for each claimed indication for use. A clinical evaluation considers available, relevant clinical data from published sources, or device-related investigations. It may be necessary to generate additional clinical data to address specific issues for certain medical devices.

If a clinical history has been well established with a given device technology, evidence may be provided in the form of a literature review of relevant publications in the peer-reviewed scientific literature. Reference to devices other than the subject device in support of safety or effectiveness requires a thorough comparison to the subject device design, features and performance capabilities to demonstrate relevance. This may be provided in a table format. Leveraged publications should be referenced but copies only need to be provided if pivotal in supporting safety or effectiveness.

Clinical evidence in the form of device-specific clinical investigations conducted in Canada or other countries should be summarized. Summaries should cover the objectives, methodology and results presented in context, clearly and meaningfully. The conclusions on the outcome of the clinical investigations should be preceded by a discussion in context with the published literature. Both statistical and clinical significance should be considered and critically analyzed.

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 judgement is required to justify why no information is required, then the heading is considered required and the justification should be provided.

4.02.01 - Clinical Evaluation Report

Folder name: 4.02.01-Clinical Evaluation Report

IMDRF common content

A clinical evaluation report reviewed and signed by an expert in the relevant field that contains an objective critical evaluation of all of the clinical data submitted in relation to the device.
A complete curriculum vitae, or similar documentation, to justify the manufacturer's choice of the clinical expert.

Classification

New and amendment applications:

Optional

4.02.02 - Device Specific Clinical Trials

Folder name: 4.02.02-Device Specific

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

Classification

New and amendment applications:

Conditionally required - If any sub-headings are required.

4.02.02.01 - [Trial description, protocol #, date of initiation]

Folder name: 4.02.02.01-Study Title, Identifier, Date (see below)

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 files, specifically the synopsis of the study and full report for the study presented. As described in the Health Canada Adapted Assembly and Technical Guide for IMDRF Table of Contents Submissions these files are to be named to ensure the sequence remains as described in the IMDRF ToC (i.e. Summary/Synopsis first followed by the Full Report second).

For example, when a pilot study and a controlled pivotal study are being presented, the application would include:

A custom folder named "4.02.02.01- EU Pilot Study, CT4203, 2010-10-10" containing:

1-CT4203Synopsis.pdf
2-CT4203Report.pdf

and a custom folder named "3.5.01.02-NA RCT Study, CT4584, 2011-01-23" containing:

1-CT4584Synopsis.pdf
2-CT4584Report.pdf

Per IMDRF content guidance, the synopsis should contain:

A summary of the specific study described in the custom heading above.
2-3 page summary document that presents a summary of:
1. The key characteristics of the study (e.g. title of study, investigators, sites, study period (date of enrollment/date of last completed), objectives, methods, # patients, inclusion/exclusion criteria) and
2. Summary of the results of the analysis
3. Summary of conclusions related to the endpoints

Note: The sponsor/applicant should explicitly address any existing regional regulatory guidance related to the components of the clinical trial synopsis.

Custom Folder Classification

New and amendment applications:

Conditionally required - This is required for each study/test presented in this section.

Synopsis File Classification

New and amendment applications:

Conditionally required - A comprehensive synopsis is required for each study/test presented in this section.

Report File Classification

New and amendment applications:

Conditionally required - A comprehensive full report is required for each study/test presented in this section.

4.02.03 - Clinical Literature Review and Other Reasonable Known Information

Folder name: 4.02.03-Lit Review-Other Known Info

IMDRF common content

Clinical literature review that critically reviews available information that is published, available, or reasonably known to the applicant/sponsor that describes safety and/or effectiveness of the device
A legible copy of key articles, including translation where applicable to meet the regulators language requirements.
OR
A statement that no literature related to the device was found.

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

Classification

New and amendment applications:

Conditionally required - When applicable to submission.

4.05 - Other Clinical Evidence

Folder name: 4.05-Other Clinical Evidence

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

Classifications

Refer to folder "4.05.00 - Overview" below for classification information.

4.05.00 - Overview

Folder name: 4.05.00-Overview

IMDRF common content

Heading for other information that may be important to the submission but that does not fit in any of the other headings of this chapter. This section is specifically intended for studies performed to ensure the safety and/or effectiveness of the device that are not delineated in the rest of the Chapter 4.

Classification

New and amendment applications:

Conditionally required - If any sub-headings are required.

4.05.01 - [Study description, study identifier, date of initiation]

Folder name: 4.05.01-Study Title, Identifier, Date (see below)

Health Canada guidance

For example, when a fatigue test and wear test are being included, the application would include:

A custom folder named "3.5.01.01-Component A Fatigue Test, MT4203, 2012-03-20" containing:

1-MT4203Summ.pdf
2-MT4203Report.pdf

and a custom folder named "3.5.01.02-Assembly B Wear Testing, MT4584, 2012-04-12" containing:

1-MT4584Summ.pdf
2-MT4584Report.pdf

Refer to the Main IMDRF ToC Implementation page for the definition of summary that describes summary content.

Custom Folder Classification

New and amendment applications:

Conditionally required - This is required for each study/test presented in this section.

Summary File Classification

New and amendment applications:

Conditionally required - A comprehensive summary is required for each study/test presented in this section. The test summary should be sufficiently detailed to stand alone in describing the evidence.

Report File Classification

New and amendment applications:

Optional

5 - Labelling And Promotional Material

Folder name: 5-LABELLING

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

5.02 - Product/Package Labels

Folder name: 5.02-Product-Package Labels

IMDRF common content

Samples of the primary and secondary packaging labels but exclusive of labels for shipping.

Note: The sponsor/applicant should explicitly address any existing regional regulatory guidance related to labelling the subject device

IMDRF Health Canada content

All labelling must be provided in English or French, both official languages are to be available upon request.
Labelling for near-patient devices must also be provided in French and English.

Health Canada guidance

Labels will be reviewed against the requirements of sections 21, 22 and 23 of the Regulations. While draft labelling may be provided initially in the licence application, final labelling will be required before a licence is issued.

The statements of indications for use and/or intended use must be clearly stated in the device labelling, and will be the official claims against which authorization will be assessed. All expressed or implied claims made elsewhere in the labelling [that is (i.e.), instructions of use, advertising, or promotional material] must be consistent with the official statement.

Labelling materials should include, as appropriate, recommended disposal techniques, the nature of combustion products, the risk of explosion, etc.

Devices sold in non-sterile condition, but intended to be used sterilized, must specify the recommended sterilization process in the labelling.

If the labelling material covers components or devices not currently licensed in Canada this should be indicated in the labelling.

Health Canada has some device-specific labelling guidance documents. These documents should be consulted for additional guidance with regard to device labelling.

Classification

New and amendment applications:

Required

5.03 - Package Insert/Instructions for Use

Folder name: 5.03-Package Insert-Instructions for Use

IMDRF common content

Package Insert/Instructions for Use included in the package, when required or provide support for why this element is not applicable.

Note: The sponsor/applicant should explicitly address any existing regional regulatory guidance related to labelling the subject device

IMDRF Health Canada content

All labelling must be provided in English or French, both official languages are to be available upon request.
Labelling for near-patient devices must also be provided in French and English
The current version of the instruction for use must be stated.

Classification

New and amendment applications:

Required

5.04 - e-labelling

Folder name: 5.04-e-labelling

IMDRF common content

For eligible medical devices and stand-alone software, the applicant needs to identify which form of e-labelling is being used in case of e-labelling (e.g. electronic storage system or built-in system, website).
Provide details of risk management in relation to e-labelling. If this is part of the overall risk management, refer to it here.
A description of the procedure and operations on providing IFU's when requested.
Provide written information for user Information on webpage where IFU and further information can be found in relevant languages.
Description on how the requirements detailed for the website have been met.

Classification

New and amendment applications:

Optional

5.05 - Physician Labelling

Folder name: 5.05-Physician Labelling

IMDRF common content

Labelling directed at the physician other than the package insert, such as the surgical manual.

Classification

New and amendment applications:

Conditionally required - If applicable for the device.

5.06 - Patient Labelling

Folder name: 5.06-Patient Labelling

IMDRF common content

Labelling directed at the patient other than the package insert, such as informational material written to be comprehended by the patient or lay caregiver.

Classification

New and amendment applications:

Conditionally required - If applicable for the device.

5.07 - Technical/Operators Manual

Folder name: 5.07-Technical-Operator Manual

IMDRF common content

Labelling directed the technical users and operators of medical devices focusing on the proper use and maintenance of the device.

Classification

New and amendment applications:

Conditionally required - If applicable for the device.

5.08 - Patient File Stickers/Cards and Implant Registration Cards

Folder name: 5.08-Patient File Stickers-Cards-Implant Registration Cards

IMDRF Health Canada content

Stickers/cards intended to be place in the patient's chart identifying the implant (e.g. serial #, lot#, make, model).
If applicable, implant registration cards.
The sponsor/applicant should explicitly address any existing regional regulatory guidance related to labelling the subject device.

Health Canada guidance

This section applies to implants as defined in Schedule 2 of the Regulations:

heart valve;
annuloplasty ring;
active implantable device systems;
all models of implantable pacemakers and leads;
all models of implantable defibrillators and leads;
artificial heart;
implantable ventricular support system; and
implantable drug infusion system.

If the subject device requires an implant registration system, the manufacturer must comply with Sections 66-68 of the Regulations. In the submission, the manufacturer is to provide samples of the implant registration cards which meet the requirements outlined in Section 66 of the Regulations.

Classification

New and amendment applications:

Conditionally required - If applicable for the device.

5.09 - Product Brochures

Folder name: 5.09-Product Brochures

IMDRF Health Canada content

Draft product brochures available at the time of application.
The sponsor/applicant should explicitly address any existing regional regulatory guidance related to labelling the subject device.

Classification

New and amendment applications:

Conditionally required - If applicable for the device.

5.10 - Other Labelling and Promotional Material

Folder name: 5.10-Other Labelling-Promotional Material

IMDRF common content

Heading for other information that may be important to the submission but that does not fit in any of the other headings of this chapter.

Classification

New and amendment applications:

Conditionally required - When information is requested by the regulator (through guidance documents or other communication) but does not belong in any of the other headings of this Chapter.

Page details

Date modified:: 2019-06-18

Class 3, non-in vitro diagnostic devices (nIVD), new and amendment applications

On this page:

1 - Regional Administrative

1.01 - Cover Letter

1.03 - List of Terms/Acronyms

1.04 - Application Form/Administrative Information

1.06 - Quality Management System, Full Quality System or Other Regulatory Certificates

1.09 - Pre-Submission Correspondence and Previous Regulator Interactions

1.12 - Letters of Reference for Master Files

1.14 - Other Regional Administrative Information

2 - Submission Context

2.02 - General Summary of Submission

2.04 - Device Description

2.04.01 - Comprehensive Device Description and Principle of Operation

2.04.02 - Description of Device Packaging

2.04.03 - History of Development

2.04.04 - Reference and Comparison to Similar and/or Previous Generations of the Device

2.05 - Indications for Use and/or Intended Use and Contraindications

2.05.01 - Intended Use; Intended Purpose; Intended User; Indications for Use

2.05.02 - Intended Environment/Setting for use

2.05.04 - Contraindications for Use

2.06 - Global Market History

2.06.01 - Global Market History

2.06.02 - Global Incident Reports and Recalls

2.06.03 - Sales, Incident and Recall Rates

2.07 - Other Submission Context Information

3 - Non-Clinical Evidence

3.04 - Standards

3.04.01 - List of Standards

3.04.02 - Declaration and/or Certification of Conformity

3.05 - Non-clinical Studies

3.05.01 - Physical and Mechanical Characterization

3.05.01.00 - Overview

3.05.01.01 - [Study description, study identifier, date of initiation]

3.05.02 - Chemical/Material Characterization

3.05.02.00 - Overview

3.05.02.01 - [Study description, study identifier, date of initiation]

3.05.03 - Electrical Systems: Safety, Mechanical and Environmental Protection, and Electromagnetic Compatibility

3.05.03.00 - Overview

3.05.03.01 - [Study description, study identifier, date of initiation]

3.05.04 - Radiation Safety

3.05.04.00 - Overview

3.05.04.01 - [Study description, study identifier, date of initiation]

3.05.05 - Software/Firmware

3.05.05.01 - Software/Firmware Description

3.05.05.02 - Hazard Analysis

3.05.05.03 - Software Requirement Specification

3.05.05.04 - Architecture Design Chart

3.05.05.05 - Software Design Specification

3.05.05.06 - Traceability Analysis

3.05.05.07 - Software Development Environment Description

3.05.05.08 - Software Verification and Validation

3.05.05.08.00 - Overview

3.05.05.08.01 - [Study description, study identifier, date of initiation]

3.05.05.09 - Revision Level History

3.05.05.10 - Unresolved Anomalies (Bugs or Defects)

3.05.05.11 - Cybersecurity

3.05.05.12 - Interoperability

3.05.06 - Biocompatibility and Toxicology Evaluation

3.05.06.00 - Overview

3.05.06.01 - [Study description, study identifier, date of initiation]

3.05.07 - Non-Material-Mediated Pyrogenicity

3.05.07.00 - Overview

3.05.07.01 - [Study description, study identifier, date of initiation]

3.05.08 - Safety of Materials of Biological Origin (human/animal)

3.05.08.00 - Overview

3.05.08.01 - Certificates

3.05.08.02 - [Study description, study identifier, date of initiation]

3.05.09 - Sterilization Validation

3.05.09.01 - End-User Sterilization

3.05.09.01.00 - Overview

3.05.09.01.01 - [Study description, study identifier, date of initiation]

3.05.09.02 - Manufacturer Sterilization

3.05.09.02.00 - Overview

3.05.09.02.01 - [Study description, study identifier, date of initiation]

3.05.09.03 - Residual Toxicity

3.05.09.03.00 - Overview

3.05.09.03.01 - [Study description, study identifier, date of initiation]

3.05.09.04 - Cleaning and Disinfection Validation

3.05.09.04.00 - Overview