An overview of the medical devices audit assessment process, including explanation about the difference between Level 1 and Level 2 audits and the information sponsors are generally required to provide.

1. Medical Devices
Audit Assessments
Mimi Chu-Gourlay
Devices Applications and Verification Section
Medical Devices Branch
Devices Sponsor Information Day 2017

2. 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 assessments
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3. 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

4. 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
Session 5 – Medical Devices – Audit assessments 3

5. 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.sments
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6. 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)
Session 5 – Medical Devices – Audit assessments 5

7. 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
Session 5 – Medical Devices – Audit assessments 6

8. 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:
Session 5 – Medical Devices – Audit assessments 7

9. Matters certified must be correct
medical 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 41FDSession 5 – Medical Devices – Audit assessments 8

10. 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
Session 5 – Medical Devices – Audit assessments 9

11. Kind of device, UPI, Variant
Class 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
Session 5 – Medical Devices – Audit assessments 10

12. 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
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13. 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
Session 5 – Medical Devices – Audit assessments
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14. 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
Session 5 – Medical Devices – Audit assessments
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15. 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
Session 5 – Medical Devices – Audit assessments
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16. 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
Session 5 – Medical Devices – Audit assessments
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17. 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
Session 5 – Medical Devices – Audit assessments
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18. 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.
Session 5 – Medical Devices – Audit assessments
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19. 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)
Session 5 – Medical Devices – Audit assessments
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20. 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
Session 5 – Medical Devices – Audit assessments
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21. 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
Session 5 – Medical Devices – Audit assessments
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22. 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
21
Session 5 – Medical Devices – Audit assessments

23. 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
• devices@tga.gov.au ph.: 1800 141 144
Contact the TGA Medical Devices Branch
Further information
Session 5 – Medical Devices – Audit assessments

25. © 2017 Brandwood Biomedical
Audit Assessments
Grant Bennett | October 9,
2017

26. © 2017 Brandwood Biomedical
AGENDA
Audit Assessments
Compulsory
or Non
Compulsory?
Key
Consideration
Summary

27. © 2017 Brandwood Biomedical
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.

28. © 2017 Brandwood Biomedical
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?

29. © 2017 Brandwood Biomedical
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.

30. © 2017 Brandwood Biomedical
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

31. © 2017 Brandwood Biomedical
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