TGA presentation: medical devices audit assessments

Medical DevicesAudit Assessments

Mimi Chu-Gourlay

Devices Applications and Verification Section

Medical Devices Branch

Devices Sponsor Information Day 2017

Purpose

Facilitate better understanding of the regulatory requirements for inclusion of

medical devices in the ARTG

Explain process for audits

Session 5 – Medical Devices – Audit assessments1

Overview• Compulsory and non-compulsory audits

• Audit assessment fees

• Lapsing applications

• Differences of Level 1 and Level 2 audits

• Information to be provided during an audit

• Unsuccessful applications

• Successful applications

• Further resources

Session 5 – Medical Devices – Audit assessments 2

Audits – To audit or not to audit?Compulsory audits

s.41FH(1)(a) – TGA must select

application for audit

MD Regulation 5.3

Does not apply if TGA issued

conformity assessment certificate

Non-compulsory audits

s.41FH(1)(b) – TGA may select

application for audit

Issues with the application or

concerns with the device


Medical devices

Applications for which must be selected for audit

Regulation 5.3(1) (a) – (j):

a. barrier (other than a condom) intended for contraception or prevention of transmission of

disease during sexual intercourse

b. implantable contraceptive device

d. device intended to disinfect another medical device

e. Class AIMD medical device

g. implantable intra-ocular lens

h. intra-ocular visco-elastic fluid

i. Class III medical device

j. some IVD medical devices (e.g. for self-testing and point of care, Class 3 IVD that is

intended for detecting presence of, or exposure to, a sexually transmitted agent, etc)

Session 5 – Medical Devices – Audit asses.sments4

What will happen?

Sponsor has:

• 20 working days to provide information

• 28 calendar days to pay the audit fee (where applicable)

• The sponsor can apply for reduction of the audit assessment fees if audit assessment can be abridged (when submitting the application)

• The application will lapse if information and/or audit assessment fee is not received.

TGA will give a written selection notice within 20 working days after your

application is received and paid:• Informing about the audit

• Requiring information relevant to the audit

• Advising of an audit fee (where applicable)


Level 1 and Level 2 - What is the difference?

Level 1 Audit

• Clarification of classification

• Conformity assessment procedures – certification and declaration of conformity

• Essential Principle 13 – information provided with the device

Level 2 Audit

• Information required for Level 1 audit PLUS one or more of the following:

• Clinical evidence

• Risk management report

• Efficacy and performance data for medical devices that are intended for disinfecting another medical devices

• Audit reports from Notified Bodies


Audit – What information is assessed?

The application

− The application is made for a kind of device and in accordance

with the form and manner approved

− For devices that must have TGA conformity assessment

certificate – such certificate is in force

− Information is not false or misleading

Matters certified by the sponsor under s.41FD are correct

Therapeutic Goods Act 1989, section 41FI Auditing of applications

TGA may consider all or some aspects of the following:


Matters certified must be correctmedical device

intended purpose

correctly classified

essential principles and availability of information to substantiate compliance

application of conformity assessment procedure and availability of information

requirements (if any) relating to advertising

prohibited imports

excluded purposes (for IVD only)

information in or with the application is complete and correct

Therapeutic Goods Act 1989, section 41FD Session 5 – Medical Devices – Audit assessments 8

What information is required to clarify the kind

of device, intended purpose and classification?

• Paragraph 41FD(a) – is the device a medical device

• Paragraph 41FD(b) – devices of that kind are intended for a specific purpose, as ascertained under subsection 41BD(2)

• Paragraph 41FD(c) – the kind of device is correctly classified according to the medical device classifications

Information provided with

the device:• Labels / packaging

• Instructions for use

• Surgical technique / manuals

• Technical documentation

Kind of device

Intended purpose

Classification• Classification rules – Schedule 2

and Schedule 2A (IVDs) of the

Regulations


Kind of device, UPI, VariantClass 4 IVD*, Class AIMD, Class III:

Same kind of medical device:

Same

Sponsor

Same

Manufacturer

Same

GMDN Code

Same

Classification

Same

Characteristics

‘a characteristic is the unique product identifier given to the device

by its manufacturer to identify the device and any variants’Section 41 BE (1)(e) of the Act & Regulation 1.6 of the Regulations

‘Variant means a medical device, the design of which has been varied, to accommodate

different patient anatomical requirements (for example, relating to the shape, size, length,

diameter or gauge of the device) or any other variation approved by the Secretary for this

definition, if the variation does not change the intended purpose of the device.Dictionary of the Regulations


Principles for applying the classification rules• All classification rules

applicable to the device must

be considered

− If more than one rule

applies, the device has

the highest level of

classification

− Examples - surgically

invasive medical devices,

transient use

Surgically invasive

medical device

intended for transient

use –

Class IIa (Rule 3.2(2))

Device incorporating

medicine –

Class III (Rule 5.1)

Surgically invasive

medical device intended

for transient use, used in

the heart or central

circulatory system –

Class III (Rule 3.2(3))

Surgically invasive

medical device intended

for transient use to

administer medicine in a

potentially hazardous

way –

Class IIb (Rule 3.2(5)(d))Session 5 – Medical Devices – Audit assessments

11

IVD classification examples• Class 1 IVDs

- Microbiological culture media; instruments/analysers• Class 2 IVDs

- Pregnancy self-tests • Class 3 IVDs

- sexually transmitted diseases; genetic tests

(inc. F.I.S.H)• Class 4 IVDs

- screen blood donors for HIV & HCV; ABO

Therapeutic Goods (Medical Devices) Regulations 2002, Division 3.1 and Schedules 2 and 2A


Conformity assessment procedure what may be required?

• Conformity assessment certification appropriate for the class of device

• Declaration of conformity

• Reports (Final, Audit, Surveillance reports)

• Documentation from the manufacturer (tests’ results, technical summary in

relation to the design of the device, etc)

• Paragraph 41FD(f) – an appropriate conformity assessment procedure has been applied to devices of that kind

• Paragraph 41FD(g) - that the applicant has sufficient information to substantiate the application of conformity

assessment procedures and/or has procedures in place, including a written agreement with the manufacturer, to

ensure such information can be obtained from the manufacturer within the period specified in the regulations


Essential principles

EP 1: Use of a medical device not to compromise health and safety

EP 3: Medical device to be suitable for intended purpose

EP 6: Benefits to outweigh any undesirable effects

EP 10: Measuring function accurate and measurements expressed in Australian legal units of measurement (Note: Not relevant to IVDs)

EP 13: Information to be provided with medical devices

EP 14: Clinical evidence – appropriate for the use and classification

EP 15: Principles applying to IVD medical devices only

• Paragraph 41FD(d) - devices of that kind comply with the essential principles

• Paragraph 41FD(e) - that the applicant has sufficient information to substantiate compliance with essential principles and/or has procedures

in place, including written agreement with the manufacturer, to ensure such information can be obtained from the manufacturer within the

period specified in the regulations


Essential principle 13 Information provided with medical device

EP 13.1 General

EP 13.2 Location – unless impracticable or inappropriate – must be provided on the device itself

EP 13.3 Particular requirements

EP 13.4 Instructions for use


Essential Principle 15 IVD medical devices only

EP 15.1 The analytical and clinical characteristics support intended use

EP 15.2 Accuracy, precision, sensitivity, specificity, stability, control of interference and measurement of uncertainty as appropriate

EP 15.3 Traceability of calibrators and controls must be assured

EP 15.4 Verification the IVD has performed as intended at the time of use

EP 15.5 Particular requirements for self-testing

EP 15.6 Instructions for self-testing must be easy to understand and apply

EP 15.7 The reduction of risk for self-testing


Other matters certified

• Do the advertising materials comply?

• Does the device contain prohibited substances?

• Is information in and with the application complete

and correct?

• Paragraph 41FD(h) – devices of that kind comply with every requirement (if any) relating to advertising applicable under part 5-1 or under the regulations

• Paragraph 41FD(i) – devices of that kind do not contain substances that are prohibited imports for the purposes of the Customs Act 1901

• Paragraph 41FD(ia) - devices of that kind are not to be used exclusively for one or more of the purposes specified under section 41BEA;

• Paragraph 41FD(j) – the information included in or with the application is complete and correct.


What will happen after TGA assess all

the information provided?

Recommendation on whether to

include the kind of device in ARTG

OR Require further information (s.41JA)


Audit assessment is complete

Audit assessment complete

Decision to include

device in ARTG

May include decision to impose additional conditions

Decision not to include device in ARTG

Provide reasons for the decision


Unsuccessful applications

TGA will notify the sponsor and provide the reasons for the decision

Sponsor should ensure that any

issues/deficiencies in the

information provided to the TGA

have been addressed before an

application to re-apply to include

the device in the ARTG is made

Request for reconsideration of an

initial decision under section 60 of

the Act can be made within 90 days

of the decision


Successful applications

Ensure all information in the application and

provided to the TGA is correct

Ensure sufficient information available to substantiate the

application of conformity assessment procedures and compliance with the essential

principles

ARTG

inclusion

21Session 5 – Medical Devices – Audit assessments

22

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

• Clinical evidence guidelines: Medical devices (https://www.tga.gov.au/publication/clinical-evidence-guidelines-medical-devices)

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

• News, consultations, guidance, subscribe to updates

• Australian Regulatory Guidelines for Medical Devices (currently under review)

TGA website

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

• Therapeutic Goods (Medical Devices) Regulations 2002 Essential principles; Classification rules; Conformity assessment procedures

Federal Register of Legislation

• [email protected] ph.: 1800 141 144

Contact the TGA Medical Devices Branch

Further information

Session 5 – Medical Devices – Audit assessments

http://www.comlaw.gov.au/Series/C2004A03952

http://www.comlaw.gov.au/Series/F2002B00237/Compilations

© 2017 Brandwood Biomedical

Audit Assessments

Grant Bennett | October 9,

2017


AGENDA

Audit Assessments

Compulsory or Non

Compulsory?

Key Consideration

Summary


Compulsory or Non-Compulsory?

• Understand the differences.

• Be sure to know which applies you.

• Understand the fees associated.

• Consider your launch strategy as a way of reducing fees.

• Review your documentation “before” submitting your application.

• Work closely with the Manufacturer before submission.

• Understand your differences ie EU v AU.

• Work to your time lines.


Key Considerations

• European vs Australian Classifications

- Does the manufacturer understand there is a difference?

- Australian DoC. DON’T SUBMIT AN EU DOC!

• Does the intended purpose support the classification?

• Ensure all claims are supported by the documents available for the device eg Claims documented in CER and collaterals?

• Is the GMDN appropriate for the device?


Key Considerations cont.

• Is the UPI supported by the documentation available?• the UPI reflected on the Design Exam and Declaration of

Conformity?

• Is it reflective of the variants of the devices?

• Make sure the Functional Description, Intended Purpose and UPI are in line

• Is the IFU supported with the appropriate evidence if required?

• Consider your groupings ie reduce the number of applications required.


Key Considerations cont.

• Ensure the Clinical Evidence Report meets Australian requirements (see afternoon session).

• Ensure your Manufacturer is aware of the differences in Australia.

• Locally produced Advertising Materials and are the claims in line?

• Sponsorship Labeling


SUMMARY

Understand your

application

Device Class and how this affects your application

process

Keep connected throughout the

process…..

but not too much!

Take time before submission

Connect with the Manufacturer early

Reach out to local experts

Health & Medicine

TGA presentation: medical devices audit assessments