Class 3, non-in vitro diagnostic devices (nIVD), new and ... · 4/12/2012 · Folder name:...

Class 3, non-in vitro diagnostic devices

(nIVD), new and amendment applications

On this page:

1 - Regional Administrative

o 1.01 - Cover Letter

o 1.03 - List of Terms/Acronyms

o 1.04 - Application Form/Administrative Information

o 1.06 - Quality Management System, Full Quality System or Other

Regulatory Certificates

o 1.09 - Pre-Submission Correspondence and Previous Regulator

Interactions

o 1.12 - Letters of Reference for Master Files

o 1.14 - Other Regional Administrative Information

2 - Submission Context

o 2.02 - General Summary of Submission

o 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

o 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

o 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

o 2.07 - Other Submission Context Information

3 - Non-Clinical Evidence

o 3.04 - Standards

3.04.01 - List of Standards

3.04.02 - Declaration and/or Certification of Conformity

o 3.05 - Non-clinical Studies

3.05.01 - Physical and Mechanical Characterization

3.05.02 - Chemical/Material Characterization

3.05.03 - Electrical Systems: Safety, Mechanical and

Environmental Protection, and Electromagnetic Compatibility

3.05.04 - Radiation Safety

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

3.05.05.09 - 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

3.05.07 - Non-Material-Mediated Pyrogenicity

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

3.05.08.01 - Certificates

3.05.09 - Sterilization Validation

3.05.09.01 - End-User Sterilization

3.05.09.02 - Manufacturer Sterilization

3.05.09.03 - Residual Toxicity

3.05.09.04 - Cleaning and Disinfection Validation

3.05.09.05 - Reprocessing of Single Use Devices

Validation Data

3.05.10 - Animal Testing

3.05.11 - Usability/Human Factors

o 3.06 - Non-clinical Bibliography

o 3.07 - Expiration Period and Package Validation

3.07.01 - Product Stability

3.07.02 - Package Validation

o 3.08 - Other non-clinical Evidence

4 - Clinical Evidence

o 4.02 - Overall Clinical Evidence Summary

4.02.00 - Overview

4.02.01 - Clinical Evaluation Report

4.02.02 - Device Specific Clinical Trials

4.02.03 - Clinical Literature Review and Other Reasonable Known

Information

o 4.05 - Other Clinical Evidence

5 - Labelling And Promotional Material

o 5.02 - Product/Package Labels

o 5.03 - Package Insert/Instructions for Use

o 5.04 - e-labelling

o 5.05 - Physician Labelling

o 5.06 - Patient Labelling

o 5.07 - Technical/Operators Manual

o 5.08 - Patient File Stickers/Cards and Implant Registration Cards

o 5.09 - Product Brochures

o 5.10 - Other Labelling and Promotional Material

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

a. 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.

b. If applicable and accepted by the regulator, it should include information

pertaining to any Master Files referenced by the submission.

c. 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).

d. If the submission is requesting approval of a change that is the result of CAPA

due to a recall, this should be stated.

e. 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).

f. 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


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

Classification


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.


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


Required

1.06 - Quality Management System, Full Quality System or Other

Regulatory Certificates

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


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


a. 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:

i. List prior submission or pre-submissions where regulator feedback was

provided

ii. Prior submissions should include identification of submission #

iii. 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.

iv. Issues identified by the regulator in prior submissions (i.e., clinical study

applications, withdrawn/deleted/denied marketing submission) for the

subject device

v. Issues identified and advice provided by the regulator in pre-submission

interactions between the regulator and the applicant/sponsor.

vi. Explain how and where the prior advice was addressed within the

submission

OR

b. 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


Conditionally required - When relevant to the application.


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


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


Conditionally required - When a Master File is referenced

1.14 - Other Regional Administrative Information

Folder name: 1.14-Other Regional Administrative Info


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


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



2.02 - General Summary of Submission

Folder name: 2.02-General Summary of Submission


a. 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).

b. Summary of submission, including

i. The type of submission (e.g. new, amendment, change of existing

application, renewal);

ii. if amendment/supplement, the reason of the amendment/supplement;

iii. 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);

iv. 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).


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


Required

2.04 - Device Description

Folder name: 2.04-Device Description



Classification


Required

2.04.01 - Comprehensive Device Description and Principle of Operation

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


a. A general description of the device, including:

i. A statement of the device name

ii. What the device does?

iii. Who uses it and for what? (high level statement)

iv. Where to use it? (places/environment where the device is intended to be

used)

v. 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).

vi. If applicable, labelled pictorial representation (diagrams, photos,

drawings).

vii. If system, how the components relate?

viii. If applicable, identify if the device incorporates software/firmware and its

role

b. Product specification, including:

i. Physical characteristics or relevance to the end user (dimensions, weight)

ii. Features and operating modes

iii. Input specifications (e.g. electrical power requirements, settings and

associated allowable ranges/limits)

iv. Output and performance characteristics (e.g. range and type of energy

delivered, resolution of images)

v. 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).

c. Engineering diagrams/prints/schematics of the device.

d. List of accessories intended to be used in combination with the devices.

e. 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).

f. Components or accessories that can be sold separately should be identified.

g. If approved by the regulator, provide the approval number and identification for

each component or accessory.

h. 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.

i. 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.

j. 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.

k. 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.


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


Required

2.04.02 - Description of Device Packaging

Folder name: 2.04.02-Description of Device Packaging


a. Information regarding the packaging of the devices, including, when applicable,

primary packaging, secondary and any other packaging associated;

b. Specific packaging of accessories marketed together with the medical devices

shall also be described;

c. 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.


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


Required


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


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


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


a. 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.

b. Description of why they were selected.

c. A key specification comparison, preferably in a table, between the references

(similar and/or previous generation) considered and the device.


a. 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).

b. 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


Required

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

Folder name: 2.05-Indications-Intended Use-Contraindications



Classification


Required

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

Folder name: 2.05.01-Intended Use and Indications


This section should include, as appropriate:

a. 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).

b. Intended Purpose: What is expected with the use of this medical device? Which

results are expected?

c. Intended user and skills/knowledge/training that the user should have to operate

or use the device.

d. Identify if the device is intended for single or multiple use

e. Indications for Use:

i. 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.

ii. If applicable, information about patient selection criteria.

iii. 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:

i. The statements of intended use and purpose and the intended user and indications

for use must be as presented in the labelling.

ii. If more than one device is included, the information should be provided for each

device

Classification


Required

2.05.02 - Intended Environment/Setting for use

Folder name: 2.05.02-Intended Environment-Setting


a. 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.

b. If applicable, environmental conditions that can affect the device's safety and/or

performance (e.g. temperature, humidity, power, pressure, movement).

Classification


Required

2.05.04 - Contraindications for Use

Folder name: 2.05.04-Contraindications


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


Required

2.06 - Global Market History

Folder name: 2.06-Global Market History



Classification


Required

2.06.01 - Global Market History

Folder name: 2.06.01-Global Market History


a. 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.

b. 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.

c. 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.

d. 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.

e. 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.

f. State the date of data capture for the market history data

g. If the subject device has been the subject of any previous compassionate use

and/or clinical trials this should be identified and, if applicable, relevant reference

numbers provided.


If there is any approval number, given to the device by the regulator authority of the

markets (country or jurisdictions) where the device is already marketed, this

identification must be informed.

a. 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


Required

2.06.02 - Global Incident Reports and Recalls

Folder name: 2.06.02-Global Incident Reports-Recalls


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

associated with this data.

a. 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.

b. 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.

c. A description of any analysis and/or corrective actions undertaken in response to

items listed above.

Note:

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

another; hence this heading is labelled as regionally focused (RF).


a. The jurisdiction(s) associated with the incident should be clearly indicated.

b. Incidents should include any Canadian incidents through SAP or other previous

Canadian applications, if known.

c. 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


Required

2.06.03 - Sales, Incident and Recall Rates

Folder name: 2.06.03-Sales Incident-Recall Rates


a. A summary of the number of units sold in each country/region and a statement of

the period associated with this data.

b. Provide the rates calculated for each country/region, for example:

i. Incident rate = # adverse events or incidents divided by # units sold x 100

ii. Recall rate = # recalls divided by # units sold x 100

c. 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.

d. 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:

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

another; hence this heading is labelled as regionally focused (RF).

ii. Sales in this context should be reported as the number of units sold.

iii. The summary of sales should be broken down by components when appropriate.

Classification


Required

2.07 - Other Submission Context Information

Folder name: 2.07-Other Submission Context Info


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





3 - Non-Clinical Evidence

Folder name: 3-NON-CLIN



3.04 - Standards

Folder name: 3.04-Standards



Classification


Conditionally required - If any sub-headings are required.

3.04.01 - List of Standards

Folder name: 3.04.01-List of Standards


a. List the standards that have been complied with in full or in part in the design and

manufacture of the device.

b. At a minimum should include the standard organization, standard number,

standard title, year/version, and if full or partial compliance.

c. If partial compliance, a list the sections of standard that

i. Are not applicable to the device, and/or

ii. have been adapted, and/or

iii. were deviated from for other reasons – discussion to accompany

Classification


Conditionally required - If demonstrating that device complies with standards


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


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


Conditionally required - If demonstrating that device complies with standards


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



Classification


Required



3.05.01 - Physical and Mechanical Characterization

Folder name: 3.05.01-Physical-Mechanical



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


Evidence that support the physical or mechanical properties of the subject device is to be

included in this section. This should include:

a. A summary of the non-clinical evidence that falls within this category

b. 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)

c. Discussion to support why the evidence presented is sufficient to support the

application.

OR

d. 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


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)


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


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

section.

Summary File Classification


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


Optional

3.05.02 - Chemical/Material Characterization

Folder name: 3.05.02-Chemical-Material



Classifications


3.05.02.00 - Overview



Tests that describe the chemical or structural composition of the device and its

components are to be included in this section. This should include:





performed)


application.

OR


to this case.



subject device.

Classification



















include:


containing:

1-MT4203Summ.pdf

2-MT4203Report.pdf


containing:

1-MT4584Summ.pdf

2-MT4584Report.pdf






section.








Optional

3.05.03 - Electrical Systems: Safety, Mechanical and Environmental

Protection, and Electromagnetic Compatibility

Folder name: 3.05.03-Electrical Systems



Classifications


3.05.03.00 - Overview



Evidence supporting electrical safety, mechanical and environmental protection, and

electromagnetic compatibility are to be included in this section. This should include:





performed)


application.

OR

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



subject device


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



















include:


containing:

1-MT4203Summ.pdf

2-MT4203Report.pdf


containing:

1-MT4584Summ.pdf

2-MT4584Report.pdf






section.








Optional

3.05.04 - Radiation Safety

Folder name: 3.05.04-Radiation Safety



Classifications


3.05.04.00 - Overview



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:





performed)


application.

OR


to this case.



subject device


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



















include:


containing:

1-MT4203Summ.pdf

2-MT4203Report.pdf


containing:

1-MT4584Summ.pdf

2-MT4584Report.pdf






section.








Optional

3.05.05 - Software/Firmware

Folder name: 3.05.05-Software-Firmware



Classification



not applicable to the device or submission.

3.05.05.01 - Software/Firmware Description

Folder name: 3.05.05.01-Description


a. Specify the name of the software

b. 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.

c. 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.

d. 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.


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


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


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

3.05.05.02 - Hazard Analysis

Folder name: 3.05.05.02-Hazard Analysis


The Hazard Analysis should take into account all device hazards associated with the

device's intended use, including both hardware and software hazards.

Note:

i. This document can be in the form of an extract of the software-related items from

comprehensive risk management documentation, described in ISO 14971.

ii. Hazard analysis, should address all foreseeable hazards, including those resulting

from intentional or inadvertent misuse of the device.

Classification




Conditionally required - When relevant to the amendment

3.05.05.03 - Software Requirement Specification

Folder name: 3.05.05.03-SRS


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





3.05.05.04 - Architecture Design Chart

Folder name: 3.05.05.04-Architecture


Detailed depiction of functional units and software modules. May include state diagrams

as well as flow charts.

Classification





3.05.05.05 - Software Design Specification

Folder name: 3.05.05.05-SDS


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





3.05.05.06 - Traceability Analysis

Folder name: 3.05.05.06-Traceability Analysis


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





3.05.05.07 - Software Development Environment Description

Folder name: 3.05.05.07-Softw Life Cycle Process Desc


A summary describing the software development life cycle and the processes that are in

place to manage the various life cycle activities.

Classification





3.05.05.08 - Software Verification and Validation

Folder name: 3.05.05.08-Software V-V



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


This heading should include:

a. An overview of all verification, validation and testing performed both in-house

and in a simulated or actual user environment prior to final release.

b. Discussion to support why the evidence presented is sufficient to support the

application.

OR

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

to this case.

Note:

i. Discussion should address all of the different hardware configurations and, where

applicable, operating systems identified in the labelling.

ii. 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






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)












include:


containing:

1-MT4203Summ.pdf

2-MT4203Report.pdf


containing:

1-MT4584Summ.pdf

2-MT4584Report.pdf






section.








Optional

3.05.05.09 - Revision Level History

Folder name: 3.05.05.09-Revision Level History


Revision history log, including release version number and date.

Classification


Conditionally required - When software is part of the device.



3.05.05.10 - Unresolved Anomalies (Bugs or Defects)

Folder name: 3.05.05.10-Unresolved Anomalies


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


Conditionally required - When software is part of the device.



3.05.05.11 - Cybersecurity

Folder name: 3.05.05.11-Cybersecurity


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

limited to:

a. Cybersecurity vulnerabilities and risks analysis

b. Cybersecurity controls measures

c. Traceability matrix linking cybersecurity controls to the cybersecurity

vulnerabilities and risks

Classification


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.



3.05.05.12 - Interoperability

Folder name: 3.05.05.12-Interoperability


If the device can communicate with other devices. Evidence to support the

interoperability should be provided.

Classification


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.



3.05.06 - Biocompatibility and Toxicology Evaluation

Folder name: 3.05.06-Biocomp-Toxicology



Classifications


3.05.06.00 - Overview



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. A list of all materials in direct or indirect contact with the patient or user.

b. State conducted tests, applied standards, test protocols, the analysis of data and

the summary of results

c. A discussion of the non-clinical testing considered for the device and support for



performed)

d. Discussion to support why the evidence presented is sufficient to support the

application.

OR

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

to this case.

Note:

i. The sponsor/applicant should explicitly address any existing regional regulatory


regarding the subject device

ii. Tests should be conducted on samples from the finished, sterilized (when supplied

sterile) device.


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



















include:


containing:

1-MT4203Summ.pdf

2-MT4203Report.pdf


containing:

1-MT4584Summ.pdf

2-MT4584Report.pdf






section.








Optional

3.05.07 - Non-Material-Mediated Pyrogenicity

Folder name: 3.05.07-Pyrogenicity



Classifications


3.05.07.00 - Overview



Studies to support pyrogenicity evaluation of final release are to be included in this

section. This should include:





performed)


application.

OR


to this case.



subject device


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



















include:


containing:

1-MT4203Summ.pdf

2-MT4203Report.pdf


containing:

1-MT4584Summ.pdf

2-MT4584Report.pdf






section.








Optional

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

Folder name: 3.05.08-Bio Material Safety



Classifications


3.05.08.00 - Overview



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. A description of biological material or derivate

b. State the harvesting, processing, preservation, testing and handling of tissues,

cells and substances

c. If applicable, discussion of infectious agents/transmissible agents known to infect

the source animal

d. 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.

e. 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.

f. The system for recordkeeping to allow traceability from sources to the finished

device should be fully described

g. Discussion to support why the evidence presented is sufficient to support the

application.

OR

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

to this case.



subject device


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






3.05.08.01 - Certificates

Folder name: 3.05.08.01-Certificates


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

abattoir inspection).

Classification


Conditionally required - When material of biological material is included in the

device that requires support with certificates associated with this material.


Conditionally required - When applicable to submission.














include:


containing:

1-MT4203Summ.pdf

2-MT4203Report.pdf


containing:

1-MT4584Summ.pdf

2-MT4584Report.pdf






section.








Optional

3.05.09 - Sterilization Validation

Folder name: 3.05.09-Sterility



Classification



3.05.09.01 - End-User Sterilization

Folder name: 3.05.09.01-End-User



Classifications


3.05.09.01.00 - Overview



Information and validation of end-user sterilization where it is necessary for the end-user

to sterilize the device. This should include:

a. A description of the sterilization process (method, parameters)

b. A summary of the non-clinical evidence that falls within this category




performed)

d. If applicable, state the rationale on the durability of the product against two or

more sterilization.

e. Discussion to support why the evidence presented is sufficient to support the

application.

OR

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

to this case.



subject device


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

information.

Classification



















include:


containing:

1-MT4203Summ.pdf

2-MT4203Report.pdf


containing:

1-MT4584Summ.pdf

2-MT4584Report.pdf






section.








Optional

3.05.09.02 - Manufacturer Sterilization

Folder name: 3.05.09.02-Manufacturer



Classifications


3.05.09.02.00 - Overview



Information and validation of manufacturer sterilization where the device is provided

sterile. This should include:

a. A description of the sterilization process (method, parameters) and Sterility

Assurance Level (SAL)

b. State if parametric release is used

c. A summary of the non-clinical evidence that falls within this category

d. 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.

e. A discussion of the non-clinical testing considered for the device and support for



performed)

f. Discussion to support why the evidence presented is sufficient to support the

application.

OR

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

to this case.



subject device


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



















include:


containing:

1-MT4203Summ.pdf

2-MT4203Report.pdf


containing:

1-MT4584Summ.pdf

2-MT4584Report.pdf






section.








Optional

3.05.09.03 - Residual Toxicity

Folder name: 3.05.09.03-Residual Tox



Classifications


3.05.09.03.00 - Overview



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:





performed)


application.

OR


to this case.



subject device.


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



















include:


containing:

1-MT4203Summ.pdf

2-MT4203Report.pdf


containing:

1-MT4584Summ.pdf

2-MT4584Report.pdf






section.








Optional

3.05.09.04 - Cleaning and Disinfection Validation

Folder name: 3.05.09.04-Clean-Disinfect Val



Classifications


3.05.09.04.00 - Overview



Contains information on the validation of cleaning and disinfection instructions for

reusable devices. This should include:





performed)


application.

OR


to this case.



subject device.

Classification



















include:


containing:

1-MT4203Summ.pdf

2-MT4203Report.pdf


containing:

1-MT4584Summ.pdf

2-MT4584Report.pdf






section.








Optional

3.05.09.05 - Reprocessing of Single Use Devices Validation Data

Folder name: 3.05.09.05-Reprocessing of SUDs



Classifications


3.05.09.05.00 - Overview



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.



subject device.

Classification


Conditionally required - Required when the purpose of the submission includes

seeking a licence for a reprocessed single use device














include:


containing:

1-MT4203Summ.pdf

2-MT4203Report.pdf


containing:

1-MT4584Summ.pdf

2-MT4584Report.pdf






section.








Optional

3.05.10 - Animal Testing

Folder name: 3.05.10-Animal Testing



Classifications


3.05.10.00 - Overview



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

should include:





performed)


application.

OR


to this case.



subject device.


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



















include:


containing:

1-MT4203Summ.pdf

2-MT4203Report.pdf


containing:

1-MT4584Summ.pdf

2-MT4584Report.pdf






section.








Optional

3.05.11 - Usability/Human Factors

Folder name: 3.05.11-Usability-Human Factors



Classifications


3.05.11.00 - Overview



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:


b. A statement of the test environment and relation to the intended use environment




performed)

d. 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.

e. Discussion to support why the evidence presented is sufficient to support the

application.

OR

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

to this case.

Note:

i. 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.

ii. The sponsor/applicant should explicitly address any existing regional regulatory


regarding the subject device.

Classification



















include:


containing:

1-MT4203Summ.pdf

2-MT4203Report.pdf


containing:

1-MT4584Summ.pdf

2-MT4584Report.pdf






section.








Optional

3.06 - Non-clinical Bibliography

Folder name: 3.06-Non-Clin Bibliography



a. A listing of published non-clinical studies involving this specific device (e.g.

cadaveric evaluations, biomechanical assessments)

b. A legible copies of key articles , including translation where applicable to meet

the regulators language requirements


application.

OR

d. A statement that no literature related to the device was found.


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








3.07 - Expiration Period and Package Validation

Folder name: 3.07-Expiration Period-Package Val



Classifications

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

3.07.00 - Overview

Folder name: 3.07.00-Overview



a. An indication of environmental conditions for correct storage of the device (e.g.

temperature, pressure, humidity, luminosity).

b. 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

c. A rationale that storage conditions could not affect device safety or effectiveness

Classification






3.07.01 - Product Stability

Folder name: 3.07.01-Product Stability



Classifications


3.07.01.00 - Overview



Contains details relating to product stability under specified storage conditions and in

final packaging or simulated conditions. This should include:





performed)


application.

OR


to this case.



subject device.


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



















include:


containing:

1-MT4203Summ.pdf

2-MT4203Report.pdf


containing:

1-MT4584Summ.pdf

2-MT4584Report.pdf






section.








Optional

3.07.02 - Package Validation

Folder name: 3.07.02-Package Val



Classifications


3.07.02.00 - Overview



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:





performed)


application.

OR


to this case.



subject device.


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



















include:


containing:

1-MT4203Summ.pdf

2-MT4203Report.pdf


containing:

1-MT4584Summ.pdf

2-MT4584Report.pdf






section.








Optional

3.08 - Other non-clinical Evidence

Folder name: 3.08-Other Non-Clin Evidence



Classifications


3.08.00 - Overview




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. A description of the purpose of the test, the risk/safety issue the test is addressing;

the test methods and results of the test



subject device.

Classification





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

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












include:


containing:

1-MT4203Summ.pdf

2-MT4203Report.pdf


containing:

1-MT4584Summ.pdf

2-MT4584Report.pdf






section.








Optional

4 - Clinical Evidence

Folder name: 4-CLINICAL



4.02 - Overall Clinical Evidence Summary

Folder name: 4.02-Overall Clinical Evidence Summary



Classifications


4.02.00 - Overview



a. 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.

b. 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.

c. 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)

d. Discussion to support why the evidence presented is sufficient to support the

application.

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


a. Provide the Investigational Testing Authorization reference number for any

clinical trials conducted under an Investigational Testing Authorization in

Canada.

b. If applicable, provide the clinicaltrials.gov reference number for any clinical

studies registered with clinicaltrials.gov.


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






4.02.01 - Clinical Evaluation Report

Folder name: 4.02.01-Clinical Evaluation Report


a. 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.

b. A complete curriculum vitae, or similar documentation, to justify the

manufacturer's choice of the clinical expert.

Classification


Optional

4.02.02 - Device Specific Clinical Trials

Folder name: 4.02.02-Device Specific



Classification



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




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

b. 2-3 page summary document that presents a summary of:

i. 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

ii. Summary of the results of the analysis

iii. Summary of conclusions related to the endpoints


guidance related to the components of the clinical trial synopsis.




section.

Synopsis File Classification


Conditionally required - A comprehensive synopsis is required for each

study/test presented in this section.



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


a. 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

b. A legible copy of key articles, including translation where applicable to meet the

regulators language requirements.

OR

c. A statement that no literature related to the device was found.


guidance related to the clinical study and data provided in this section regarding the

subject device

Classification


Conditionally required - When applicable to submission.

4.05 - Other Clinical Evidence

Folder name: 4.05-Other Clinical Evidence



Classifications


4.05.00 - Overview




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



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

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












include:


containing:

1-MT4203Summ.pdf

2-MT4203Report.pdf


containing:

1-MT4584Summ.pdf

2-MT4584Report.pdf






section.








Optional

5 - Labelling And Promotional Material

Folder name: 5-LABELLING



5.02 - Product/Package Labels

Folder name: 5.02-Product-Package Labels


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

shipping.


guidance related to labelling the subject device


a. All labelling must be provided in English or French, both official languages are to

be available upon request.

b. Labelling for near-patient devices must also be provided in French and English.


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


Required

5.03 - Package Insert/Instructions for Use

Folder name: 5.03-Package Insert-Instructions for Use


Package Insert/Instructions for Use included in the package, when required or provide

support for why this element is not applicable.


guidance related to labelling the subject device


a. All labelling must be provided in English or French, both official languages are to

be available upon request.

b. Labelling for near-patient devices must also be provided in French and English

c. The current version of the instruction for use must be stated.

Classification


Required

5.04 - e-labelling

Folder name: 5.04-e-labelling


a. 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).

b. Provide details of risk management in relation to e-labelling. If this is part of the

overall risk management, refer to it here.

c. A description of the procedure and operations on providing IFU's when requested.

d. Provide written information for user Information on webpage where IFU and

further information can be found in relevant languages.

e. Description on how the requirements detailed for the website have been met.

Classification


Optional

5.05 - Physician Labelling

Folder name: 5.05-Physician Labelling


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

manual.

Classification


Conditionally required - If applicable for the device.

5.06 - Patient Labelling

Folder name: 5.06-Patient Labelling


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



5.07 - Technical/Operators Manual

Folder name: 5.07-Technical-Operator Manual


Labelling directed the technical users and operators of medical devices focusing on the

proper use and maintenance of the device.

Classification



5.08 - Patient File Stickers/Cards and Implant Registration Cards

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


a. Stickers/cards intended to be place in the patient's chart identifying the implant

(e.g. serial #, lot#, make, model).

b. If applicable, implant registration cards.

c. The sponsor/applicant should explicitly address any existing regional regulatory

guidance related to labelling the subject device.


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



5.09 - Product Brochures

Folder name: 5.09-Product Brochures


a. Draft product brochures available at the time of application.

b. The sponsor/applicant should explicitly address any existing regional regulatory

guidance related to labelling the subject device.

Classification



5.10 - Other Labelling and Promotional Material

Folder name: 5.10-Other Labelling-Promotional Material



fit in any of the other headings of this chapter.

Classification




other headings of this Chapter.

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