Manufacturer Evidence and applications for

inclusion in the ARTG

Medical Devices

Susan Barker

Devices Application and Verification Section

Medical Devices Branch

Devices Sponsor Information Day

11 October 2017

Purpose

Facilitate better understanding of the regulatory requirements for medical devices

ARTG inclusion – explain the process and give some examples

2

Overview

• Key definitions and regulatory framework

• Manufacturer’s Evidence

• Information in an application

• Avoiding common problems in applications

3

What is a medical device?

• Used for human beings

• Intended purpose

– Diagnosis, prevention, monitoring, treatment or alleviation of disease or compensation for injury

or disability

– Investigation, replacement or modification of anatomy or physiological processes

– Control of conception

• Principal intended action

– Not by pharmacological, immunological or metabolic means

• Definition of IVD in the MD Regulations

• Products declared to be or not to be a medical device

– Therapeutic Goods (Articles that are Medical Devices) Specification and/or

Therapeutic Goods (Articles that are not Medical Devices) Orders

• Accessory to a medical device as described aboveTherapeutic Goods Act 1989, section 41BD 4

What is an IVD?

• A reagent, calibrator, control material, kit, specimen receptacle, instrument,

software, equipment or system

• Intended for the in vitro examination of human specimens for

– giving information about a physiological or pathological state

– giving information about a congenital abnormality

– determining safety and compatibility with a potential recipient

– monitoring therapeutic measures

Therapeutic Goods (Medical Devices) Regulations 2002, Dictionary5

ARTG inclusion

• Any medical device must be included in ARTG

• Except:

- Exempt devices (e.g. custom-made medical devices)

• Sponsor is responsible for ARTG inclusion

• Before you start

• TGA Business Services (TBS)

– Register and get your Client ID

6

Process for ARTG inclusion

Basics - process through TGA

7

Manufacturer evidence• Manufacturer must apply appropriate conformity assessment procedure to the device

(quality management system and control over the design of the device)

• Sponsor must lodge the manufacturer’s certification of the conformity assessment with the

TGA

- Except for Class I medical devices (no measuring function and/or not supplied sterile),

Class 1 IVD, and/or Export Only

• TGA conformity assessment certificate

• EC Certificate issued under MDD 93/42/EEC, AIMDD 90/385/EEC, IVD 98/79/EC

• MRA certificates issued by EU Notified Body (with certain exceptions)

• Declarations of conformity made under Clause 7.5 of Schedule 3 (systems or procedure

packs)

• ISO 13485 for IVDs only 8

Manufacturer Evidence

Submitted

Accepted

−What does it mean?

Go to the next step - lodging application

for ARTG inclusion

9

Application for ARTG inclusion

• Must be made for a kind of device and

• Must be made in accordance with a form and manner approved (via TBS) and

• Application fee must be paid and

• For the devices that must have TGA conformity assessment certificate – such certificate is in force and

• Must not contain information that is false or misleading in a material particular

Therapeutic Goods Act 1989, sections 41FC and 41EA, and Therapeutic Goods (Medical Devices) Regulations 2002, regulation 4.1

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What we look at

Kind of device

Intended Purpose

GMDN Code

Device Product Characteristics

Classification

Conformity Assessment Procedures

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Kind of device

• Sponsor

• Manufacturer

• Device nomenclature system code (GMDN)

• Classification

• Unique product identifier (UPI)(for Class III and active implantable medical devices (AIMD), and Class 4IVD, except immunohaematology reagent)

a medical device is taken to be of the same kind as

another medical device if they have the same:

Therapeutic Goods Act 1989, section 41BE and Therapeutic Goods (Medical

Devices) Regulations 2002, regulations 1.6 and 1.7 12

Intended purpose of a kind of device• Means the purpose for which the manufacturer of the device intends

it to be used, as stated in the information provided with the device

(labelling, instructions for use, advertising material and technical

documentation)

• Intended purpose stated in the application must be consistent with

the purpose for which the manufacturer intends the devices of the kind

to be used

Note: The manufacturer must have evidence that the device

performs as intended (refer essential principles)

13

Global Medical Device Nomenclature (GMDN)

- One of the characteristics that defines the kind of device

- Is to be consistent with the intended purpose of the device

- Must be the code that best describes the kind of device

- For medical devices (not-IVD) – relevant preferred term (except Class

I – relevant template term)

- For IVDs - collective terms (Level 1, 2 or 3) (except

Class 4IVD that is not immunohaematology reagent - relevant

preferred term)

Manufacturer’s responsibility14

Device Product Characteristics• Ensure ‘Device Product Characteristics’ section in the application is

correctly filled in

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Medical devices are classified having regard to the intended purpose of the device

Class I Class Is and

Class Im

Class IIa Class IIb Class III and

AIMD

The lowest level The highest level

Therapeutic Goods (Medical Devices) Regulations 2002, Part 3

Division 3.1 and Schedules 216

IVD medical devices are classified having regard to the

intended purpose of the device and its risk to public health and/or personal risk

• Class 1 IVD – no public health risk or low personal risk

• Class 2 IVD – low public health risk or moderate personal risk

• Class 3 IVD – moderate public health risk or high personal risk

• Class 4 IVD – high public health riskRIS

K

Therapeutic Goods (Medical Devices) Regulations 2002, Schedules 2A17

Conformity assessment procedure

• Minimum conformity assessment procedures for different Classes of devices

• Sufficient information to demonstrate application of the appropriate conformity assessment procedures to the kind of device

Part 3 Division 3.2 and Schedule 3, Therapeutic Goods (Medical Devices) Regulations 2002

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Conformity assessment procedures• Minimum conformity assessment procedures for different Classes of

devices

Class Is device

(e.g. Sterile surgical gown)

Class III device

supplied sterile

(e.g. Knee Femur)

Annex II.3 - Full Quality Assurance

Annex V – Production Quality

Plus

Declaration of conformity

(Part 6, Schedule 3)

Annex III - Type Examination

Plus:

Annex V - Production Quality Assurance

Annex II.3 - Full Quality Assurance

Plus

Annex II.4 - Examination of Design

OR

OR

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One page document• Describe the device and intended purpose if needed in more detail

• Cite the classification rules in accordance with

Schedule 2 or 2A of the Regulations and provide justification where

required

• Explain how the kind of device is covered under the scope of certificate

included in Manufacturer’s Evidence

• Make sure all the information is complete and correct

• Do not attach more than one page

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Information provided in the application• Do not attach information that is not relevant with the

application, for example:

– Declaration of conformity made under EU Medical Device Directive

– Audit and/or technical data reports

• Ensure intended purpose is clear and correct

• Ensure the device is classified correctly

• Ensure the Manufacturer’s Evidence stated in the application contains correct certificate

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Examples of common mistakes

Incorrect Device

Product Characteristics

GMDN code not most

relevant for the kind of

device

Incorrect Classification

Scope of EC certificate

does not correctly cover

the kind of device

Attaching documents not

relevant, which do not

meet requirements

22

Where do we go from here?

Matters certified under s.41FD Ensure all information provided is correct

Any application may be selected for audit

Some applications must be selected for audit

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SME Assist

• Guidance on TGA website

• Interactive online tool

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Further information

• Medical devices (http://www.tga.gov.au/medical-devices-ivds)

• SME Assist (https://www.tga.gov.au/sme-assist)

TGA website

• Therapeutic Goods Act 1989 Chapter 3, Part 4-5

• Therapeutic Goods (Medical Devices) Regulations 2002

Federal Register of Legislation

• devices@tga.gov.au ph.: 1800 141 144

Contact the TGA Medical Devices Branch

25

Thank you!

26

Juliana WilliamSr RA Associate

Baxter Healthcare

11/10/2017 Devices Sponsor Information Day 28

AgendaSuccessful and Efficient Submission

Preparation

Checks to do

Additional information

Non-mandatory audit submissions

This presentation will not cover details of:

• Systems and Procedure Packs

• Conformity Assessment

• Audit Assessment

• Class III/AIMD, UPI and Variants

• Clinical Evidence & Risk Assessment compliance

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Common DeficienciesManufacturer Evidence

(ME)

• Two or more

certificates are

provided

• EU declaration of

Conformity

• ISO 13485 certificate

• Incomplete certificate

(missing attachments)

• Incorrect annex route

• Incorrect directive

• Not in English!

Device Application (DA)

• GMDN code does no

match the ‘Intended

purpose’

• Wrong classification

• Device is not covered in

the EC Certificate scope

• Route of conformity (EC

Certificate Annex) is not

appropriate for the

proposed Class

• Wrong manufacturer

evidence!

Administrative

• Missing documents or

pages!

• TGA evaluator unable to

find information easily

• Poor hyperlinking and

bookmarking

• Spelling errors

• Poor English Translation

• Missing signatures!

• Application fees not

processed

11/10/2017 Devices Sponsor Information Day 30

Preparation Ensure a legal/quality/distribution agreement is/are in place which outline

clearly roles and responsibilities for post-market monitoring, vigilance and reporting obligations

Obtain Australian Declaration of Conformity from manufacturer Make sure you have the right template for class and conformity route. See

http://www.tga.gov.au/industry/devices-forms-declaration-conformity.htm

Ensure the codes listed are the code to be registered and marketed

Obtain Australian Essential Principles Checklist from manufacturer● Ensure compliance with all standards applied and compliance with the Australian EP. Section 8 of the ARGMD

explain the differences between EU ER and Australia EP.

Product Labelling and Instruction for Use

Risk Management Report and Clinical Evaluation Report

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Checks to Do

Check whether the device: Sterile? What is the sterilisation method

Measuring function?

Invasive?

Reusable or Single Use?

Active?

Single product or System or Procedure pack?

Contains a medicine?

Contains material or ingredients of microbial/ recombinant / GMO/ animal/ human origin? Country of origin?

Is the device classified correctly according to the TGA Classification Rules? (Schedule 2 of The Regulations)

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Checks to Do

The medical devices regulatory

framework has a classification system

for medical devices.

The detailed legislation is in:

• 41BD of the Therapeutic Goods Act

1989 (the Act)

• Regulation 3.2 of the Therapeutic

Goods (Medical Devices)

Regulations 2002 (the Regulations)

• Schedule 2 of the Regulations.

11/10/2017 Devices Sponsor Information Day 33

Checks to Do• Is the assigned GMDN code appropriate? (Section 10 of the Regulation)

Remember that manufacturer assign the GMDN code.

Check if the GMDN is on the TGA database. If the GMDN code is not in the TGA database, ask for it to be added in advance by email to ebs@tga.gov.au

There may be differences between the GMDN Agency code table database and the TGA code table database.

Based on the Device information, is the GMDN appropriate and reflects the intended purpose?

Must be a preferred term

Does the device perform according to its intended purpose? This should be a detailed description of the manufacturers intended purpose and should closely

align with the relevant GMDN description Remember: Intended purpose is different from Functional description (describes the

operation of the medical device, not its composition)

11/10/2017 Devices Sponsor Information Day 34

Checks to Do

● Is the device same kind of medical device (Section 41BE of The Act)?

A medical device is of the same ‘kind’ if it has the same: Intended purpose

Classification

GMDN code

Legal manufacturer

Sponsor

Does it have appropriate evidence of Conformity Assessment? ARGMD Section 5 Conformity Assessment Overview Need to check the appropriate level and route is held by the manufacturer

according to the classification

11/10/2017 Devices Sponsor Information Day 35

Checks to Do

11/10/2017 Devices Sponsor Information Day 36

Checks to Do

There are a number of

important details that a

sponsor should check to

ensure that the certificate

is valid for particular

devices.

Refer to Section 7 of the

ARGMD

11/10/2017 Devices Sponsor Information Day 37

Additional InformationIf there is additional information that could help the assessor, then it would be beneficial to attach a ONE PAGE ONLY document with the application illustrating:

A Picture/diagram of the device

A description of the device (not the intended purpose)

A description of the mechanism of action (how it works)

How the device is included in the scope of the CE Certificate

Evidence of the same kind of medical device (for multiple devices)

11/10/2017 Devices Sponsor Information Day 38

Non-mandatory audit Any Device Application is subject to non-mandatory audit.

Be prepared to submit any documents from Level 1 or 2 audit list, as well as anything else you may

need to show compliance with any of the Essential Principles or Conformity Assessment

Procedures.

Examples: Compliance with Essential Principles

Notified Body audit reports to verify the validity of the EC Certificate

Product labelling and IFU

Explanation and justification of Classification

Recent Clinical Evaluation Report

Recent Risk Management File

Compliance with particular standards (or justification why it is not complied with)

Remember you declare you can submit in 20 days!

11/10/2017 Devices Sponsor Information Day 39

Non-mandatory audit Provides all items requested by the TGA

Electronic and easy to navigate (entire document):

Clear table of content (hyperlinking and bookmarking work!)

Text readable

Page numbers throughout

Up-to-date Clinical Evidence Report (signed by a clinical expert!)

Up-to-date Risk Management File

Well prepared submission will:

Allow the delegate to easily navigate and find information quickly.

Reduce the number of questions raised by the delegate

Speed approval

The better quality the submission, the easier it is to read and evaluate

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Wrap Up Make sure you understand your product.

Do your preparation and verify information before submission! Time spent before submitting is well worth it and will increase your success rate

Engage your cross function team (R&D/Quality/Medical/Clinical..etc) well in advance of your submission plan. Discuss application requirements and TGA’s expectation.

Submit meaningful, helpful and well-set out information. Perform second check before sending application and electronic files Clearly explain the scope of your application in the cover letter

Provide comprehensive Table of Content

Ensure all hyperlinks and bookmarks are actually working

Ensure all documents and attachments are provided with the application!

Don’t submit extra documents that aren’t useful or haven’t been requested

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References

The Act

Therapeutic Goods Act 1989

The Regulations

Therapeutic Goods (Medical Device) Regulations 2002

ARGMD

Australian Regulatory Guidance for Medical Devices

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Questions?

11/10/2017 Devices Sponsor Information Day 43