Update from the Medical Devices Branch
Use of market authorisation evidence from comparable overseas
regulators / assessment bodies for medical devices
Irina Tsyganova
Director, Devices Applications and Verification
Medical Devices Branch
Therapeutic Goods Administration, Department of Health
ARCS Conference
22 August 2018

Overview
• Review of Medicines and Medical Devices Regulation recommendations and what
is changing
• Abridgement of TGA conformity assessment
– Examples of the use of overseas reports for requests for abridgement
• Applications for ARTG inclusion
– Preliminary assessments and conformity assessment documents
– Examples of the approved overseas regulator conformity assessment
documents
– Examples of decisions on selecting applications for audit

Review of Medicines and Medical Devices Regulation
Recommendations accepted by the Australian Government from the Expert Panel
Review of Medicines and Medical Devices Regulation (MMDR) include:
• Better utilisation of marketing approvals of medical devices where the device has
been
- conformity assessed by a body that has been designated to undertake conformity
assessments by a comparable overseas designating authority or
- approved by a comparable overseas national regulatory authority
• TGA retain responsibility for making decisions regarding market authorisation of
therapeutic goods in Australia
! The TGA will continue to assess applications for conformity assessment
certificates for some devices and for the inclusion of medical devices in
the Australian Register of Therapeutic Goods (ARTG)

Overseas documents that TGA will consider
• For the purposes of abridgement of TGA conformity assessments or as the documentation
required for ARTG inclusion applications, TGA will consider documents and/or
assessment reports issued by:
- Notified Bodies designated under European Union medical device regulatory frameworks
- United States Food and Drug Administration (FDA)
- Health Canada
- Japanese authorities
- Medical Device Single Audit Program (MDSAP) Auditing Organizations (AO)
• The documentation must be issued for the same medical device as you are applying for
in Australia with:
- the same design
- the same intended purpose and
- intended for the same clinical indications

Compliance with the essential principles
! Remember, you still must comply with the essential principles
• All devices supplied in Australia must comply with the Australian essential
principles of safety and performance, including the labelling requirements
• Schedule 1 of the Therapeutic Goods (Medical Device) Regulations 2002
- Compilation No 37, Compilation start date: 1 July 2018
(https://www.legislation.gov.au/Details/F2018C00490), and
- Unincorporated Amendments: Therapeutic Goods (Medical Devices) Amendment
(Implantable Medical Devices) Regulations 2017 (F2017L01692)
https://www.legislation.gov.au/Series/F2002B00237)

How overseas
market
authorisation can
be used
Providing
documents in
applications
for ARTG
inclusion
Applying for
abridgement
of TGA
conformity
assessment

Abridgement of TGA conformity assessment
• Documents should demonstrate that manufacturers’ quality management systems
(QMS) meet certain requirements (against the relevant conformity assessment
procedure), and that the devices comply with the relevant essential principles
- An overseas audit report or product evaluation report may contain information
that demonstrates that the requirements are met
- Reports should be relevant to the TGA’s conformity assessment and should
facilitate reduction of the TGA work that must be undertaken on a particular
application

Example A – use of overseas initial audit report for an application
for TGA conformity assessment certificate
• Schedule 3, Part 1 - Full Quality Assurance procedures certificate
– Requires QMS assessment and Design-examination certificates
– The manufacturer has an EU Medical Device
Directive (MDD) Full Quality Assurance (FQA)
audit report
– The FQA audit report is an initial audit report that covers
the same manufacturing sites and device categories as
in the application to the TGA
• Applicant may provide the FQA audit report to the TGA
with the supporting documentation for the application
• If the report is sufficiently detailed, we may be able to
reduce the assessment by undertaking a desktop
assessment of the QMS instead of an on-site audit

Example B - use of overseas re-audit report for an application for
TGA conformity assessment certificate
• Schedule 3, Part 1 - Full Quality Assurance procedures certificate
– Requires QMS assessment and Design-examination certificates
– The manufacturer has an EU Medical Device
Directive (MDD) Full Quality Assurance (FQA)
audit report
– The FQA audit report is a recertification audit
report (re-audit) that covers the same manufacturing
sites and device categories as in the application
to the TGA
• Applicant may provide the FQA audit report (re-audit)
to the TGA with other documentation for the application
• If the report is sufficiently detailed, we may be able to
reduce the assessment by undertaking a desktop
assessment of the QMS instead of an on-site audit

Example C - assessing substantial change to TGA Production
quality assurance certificate
• Manufacturer has a valid TGA conformity assessment
certificate issued under Schedule 3,
Part 4 - Production quality assurance certificate and
requires assessment of substantial change(s)
– The manufacturer has an MDSAP Audit Report for a
surveillance audit that includes assessment of the
change
– Applicant may provide the MDSAP audit report
to the TGA with other documentation for
the application
• If the report is sufficiently detailed and the change
has been assessed as satisfactory by the AO,
we may be able to abridge the assessment
of the change

Applications for ARTG inclusion
• Applications must pass preliminary assessment
‒ Must be made in accordance with a form and manner
approved for classification of a medical device
‒ Application fee must be paid
‒ Application must be accompanied by the kind of information
prescribed for the application of this classification by
legislative instrument and provided in an approved form
‒ For the devices that must have TGA conformity assessment
certificate – such certificate is in force
‒ The applicant has certified the section 41FD matters
Therapeutic Goods Act 1989, section 41FDB

Application form and manner approved
• Medical Device Applications and IVD Applications must be made electronically via TGA
Business Services client’s portal
• There are separate forms approved for different classifications
- Sponsors must select correct form depending on
the Class of their device
• Sponsors must fill in all relevant fields in the application form
• Manufacturer Evidence ID is one of the mandatory fields in the application form
Paragraph 41FDB(2)(a)

Conformity assessment procedures or comparable procedures
• The conformity assessment procedures or comparable procedures set out the requirements
relating to the application of manufacturers’ quality management systems for medical devices and
other requirements imposed on manufacturers, specifically in relation to the design and
production of medical devices
Conformity assessment documents
provided with ARTG inclusion application
(Evidence of product assessment)
Conformity assessment documents included as
Manufacturer Evidence (QMS Certification)

Conformity assessment evidence – status quo
• Sponsors must have sufficient information available (or have access to such
information) to substantiate the application by the manufacturer of appropriate
conformity assessment procedures to the device they seek pre-market
authorisation for:
- Conformity assessment certificates issued by the TGA
(Schedule 3, Therapeutic Goods (Medical Devices) Regulations 2002)
- EC Certificates issued by European Notified Bodies
(Council Directives 93/42/EEC, 90/385/EEC, 98/79/EC)
- Declarations of conformity for Class I/Class 1IVD and for systems and
procedure packs, and ISO 13485 for IVD medical devices

What has changed?
• Overseas regulator conformity assessment documents (on its own or in combination with other
documents) that demonstrate requirements comparable to the conformity assessment procedures
now also include:
- Certificates issued by Notified Bodies under EU Medical Device Regulation 2017/745 and
IVD Regulation 2017/746 (in addition to current EC Certificates)
- Premarket Approvals (PMA)/510(k) Clearances/De novo summaries issued by US FDA
- Certificates and licences issued under the Canadian Medical Device Regulations
- Pre-market approvals from Japan (issued by the Ministry of Health, Labour and Welfare
(MHLW), Pharmaceutical and Medical Devices Agency (PMDA) or Registered Certified Body
(RCB), whichever is relevant)
- Certificates issued under the MDSAP

Example A – Medical Device Application for Class Is
• Application for inclusion in the ARTG of Class I medical device
intended to be supplied sterile
– The manufacturer has EC Certificate issued by the European
Notified Body under
EU MDD 93/42/EEC
• Sponsor is required to provide
– Manufacturer Evidence
 EC Certificate issued under either Annex II.3 or Annex V
– Documentation that must be provided with
the application for inclusion of the medical
device in ARTG
 In this case, no information is required

Example B – Medical Device Application for Class IIb
• Application for ARTG inclusion of Class IIb medical device
– The manufacturer has MDSAP Certificate for the QMS and
product approvals from FDA and/or Health Canada
• Sponsor is required to provide
– Manufacturer Evidence
 MDSAP Certificate
! The MDSAP certificate must be issued to the manufacturer
stated on the labelling and instructions for use as the
manufacturer of the kind of device for which application is
submitted
– Documentation that must be provided with the application for
inclusion of the medical device in ARTG
 Health Canada: Medical device licence Class III or
 US FDA: De Novo or 510(k) or PMA

Example C – IVD Application for Class 3IVD
• Application for inclusion in the ARTG of Class 3 IVD
– The manufacturer has EC Certificate issued by the
European Notified Body under
IVDD 98/79/EC
• Sponsor is required to provide
– Manufacturer Evidence
 EC Certificate issued under either Annex IV.3
or Annex VII
– Documentation that must be provided with
the application for inclusion of the medical
device in ARTG
 In case of EC Certificate issued under Annex IV.3 no
information is required
 In case of EC Certificate issued under Annex VII a Type
Examination Certificate issued under Annex V is
required

‘Use of market authorisation evidence from comparable
overseas regulators / assessment bodies for medical devices’
• Guidance document available on the TGA website
• Please review
– Table 1 - Evidence that may be used for abridgement of
TGA conformity assessment
– Table 2 - Information that must accompany ARTG inclusion
applications
! The categories of documents included as the Manufacturer
Evidence and the Evidence of product review attached
with ARTG inclusion application must appear in the same
line in Table 2 to be accepted as the information approved
to accompany the application

Application audit assessments
• Applications for ARTG inclusion of certain medical devices must be selected for audit
- Regulation 5.3
• TGA also may select any ARTG inclusion application for audit where there are any
concerns about the device or information provided in the application
• The level of audit may depend on the category and/or Class of a medical device, and the
overseas regulator conformity assessment document provided in the application
• Sponsors can submit requests with their applications requiring abridgement of the audit
assessment (including requests to abridge the level of audit if appropriate)
– Sponsors are required to provide justification supporting their requests
– TGA’s delegate will decide whether such request is appropriate
– The guidance on requests for abridged assessment is available on the TGA website

Decision on level of audit for Class III/AIMD application
• ARTG inclusion application for Class III or AIMD for which the manufacturer has FDA PMA
• Class III/AIMD ARTG inclusion application that passes preliminary assessment (for which a TGA-
issued conformity assessment certificate is not in force) must be selected for application audit
• Level of application audit:
– Decision on the audit level is based on information provided in the application and/or information
or signals that the TGA has regarding the device (or similar devices)
• Level 2 audit if:
– device does not appear to be the same as the device specified in the PMA (including differences
in the UPI, design, intended purpose or clinical indications) or
– there are other signals that raise safety or performance concerns
• Level 1 audit if:
– If none of the criteria for Level 2 audits apply, the application will usually
undergo a Level 1 audit

Application for Class 3IVD for self-testing or POCT
• ARTG inclusion application for Class 3IVD for self-testing or for point of care testing (POCT) for
which the manufacturer has MDSAP Certificate and
FDA 510(k)
• ARTG inclusion application for self-testing or for POCT IVD that passes preliminary assessment
(for which a TGA-issued conformity assessment certificate is not in force) must be selected for
application audit
• Level of application audit - technical file review
– TGA request information that demonstrate compliance with the essential principles
TGA provide further examples on selecting applications for audit and expected level of audit
assessment in Q&A published on TGA website

Further information
Therapeutic Goods Act 1989
https://www.legislation.gov.au/Series/C2004A03952
– Chapter 4 – Medical Devices
Therapeutic Goods (Medical Devices) Regulations 2002
https://www.legislation.gov.au/Series/F2002B00237