Medical Devices Manufacturer Evidence and applications for inclusion in the ARTG

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

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Overview ••••

Key definitions and regulatory framework Manufacturer’s Evidence Information in an application Avoiding common problems in applications

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What is a medical device? ••

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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 above Therapeutic Goods Act 1989, section 41BD

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What is an IVD? •

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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, Dictionary 5

ARTG inclusion ••

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• •

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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 startTGA Business Services (TBS)

Register and get your Client ID 6

Process for ARTG inclusion Basics - process through TGA

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Manufacturer evidence •

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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

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Submitted Accepted

What does it mean?

Go to the next step - lodging application for ARTG inclusion

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Application for ARTG inclusion ••

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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 andMust 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 Procedures11

Kind of device

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

another medical device if they have the same:

• 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)

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 •

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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)

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Global Medical Device Nomenclature (GMDN) ----

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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 responsibility 14

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

The lowest level

Class Is and Class Im

Class IIa Class IIb Class III and AIMD

The highest level

Therapeutic Goods (Medical Devices) Regulations 2002, Part 3 Division 3.1 and Schedules 2 16

IVD medical devices are classified having regard to the intended purpose of the device and its risk to public health

and/or personal risk

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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 risk RIS

K

Therapeutic Goods (Medical Devices) Regulations 2002, Schedules 2A 17

Conformity assessment procedure

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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 ••

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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 •

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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

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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

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Guidance on TGA website Interactive online tool

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Further information TGA website • Medical devices (http://www.tga.gov.au/medical-devices-ivds)• SME Assist (https://www.tga.gov.au/sme-assist)

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Federal Register of Legislation

Therapeutic Goods Act 1989 Chapter 3, Part 4-5 Therapeutic Goods (Medical Devices) Regulations 2002

ntact the TGA Medical Devices Branch • devices@tga.gov.au ph.: 1800 141 144

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Contact the TGA Medical Devices Branch

TGA website

Thank you!

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Juliana William Sr RA Associate

Baxter Healthcare

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Agenda Successful 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 Deficiencies Manufacturer 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

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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 ClassificationRules? (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: •

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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.

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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)

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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

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Checks to Do

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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

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Additional Information If 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)

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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!

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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?

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