This document provides an overview of manufacturer evidence requirements for medical devices in Australia. It discusses what constitutes manufacturer evidence, the minimum conformity assessment procedures required based on device classification, and how to accurately submit new or varied manufacturer evidence applications via the TGA's electronic business services system. Common issues with manufacturer evidence submissions like incomplete certificates or multiple documents being attached are also outlined.

2. Session B2: Medical Devices
Accurate Manufacturer Evidence
Carol Hanrahan
Departmental Officer
Devices Application and Verification Section
Office of Devices Authorisation
Sponsor Training Day - 9 September 2014

3. Overview
• Manufacturer Evidence
• Minimum conformity assessment procedures
• Manufacturer Evidence via electronic Business Services
(eBS)
• New Manufacturer Evidence
• Variation to Manufacturer Evidence
• Common issues with submitting Manufacturer Evidence
Session B2: Medical Devices – Accurate Manufacturers Evidence

4. Manufacturer Evidence
Manufacturer Evidence (ME) constitutes a certificate that
demonstrates that appropriate conformity assessment
procedures have been applied by the manufacturer to a kind(s)
of medical device(s).
• Acceptance of ME by the TGA is the first step before applying
for a medical device to be included in the Australian Register of
Therapeutic Goods (ARTG).
• ME is submitted via electronic Business Services (eBS) to
obtain a Manufacturer Evidence identifier. The ME identifier is
a number used when submitting an application for inclusion of
a medical device in the ARTG.
Session B2: Medical Devices – Accurate Manufacturers Evidence

5. Manufacturer Evidence (cont.)
• Application for a medical device to be included in the
ARTG must be made in accordance with a form approved
by the Secretary.
• The Manufacturer Evidence identifier is to be entered on
the form in electronic Business Services (eBS):
Session B2: Medical Devices – Accurate Manufacturers Evidence

6. Evidence of conformity assessment procedures
The TGA accepts the following certificates as evidence of the
application of an appropriate conformity assessment procedure:
• Conformity Assessment Certificate issued by the TGA.
• MRA (Mutual Recognition Agreement) Certificates issued by an EU
Notified Body in accordance with Australian regulatory requirements
– Australia-EC MRA
– Australia-EFTA MRA
• EC certificate issued by an EU Notified Body in accordance with EU
regulatory requirements and Directives.
Australia has signed a Mutual Recognition Agreement
(MRA) with the European Community (EC)
Australia has signed a European Free Trade Agreement
(EFTA) with the Republic of Iceland, the Principality of
Liechtenstein and the Kingdom of Norway
Session B2: Medical Devices – Accurate Manufacturers Evidence

7. Minimum Conformity Assessment Procedures
• A medical device requires the application of appropriate
conformity assessment procedures relevant to its
classification
• Part 3, Division 3.2 of the Therapeutic Goods (Medical
Devices) Regulations 2002 (the Regulations) sets out the
minimum conformity assessment procedures that must be
applied to different classes of medical devices
• Schedule 3 of the Regulations sets out the conformity
assessment procedures
• Australian Vs European
Session B2: Medical Devices – Accurate Manufacturers Evidence

8. Classification & Conformity Assessment Procedures Required (1)
* devices other than devices to be used for a special purpose (medical device used for a special purpose means a medical device to which regulation 3.10 applies; Part 7 of
Schedule 3 provides procedures that must be applied to medical devices used for a special purpose)
** CAC – conformity assessment certificate (conformity assessment certificate means a certificate issued under section 41EE of the Act, this means certificate issued by the TGA) or
Certificate issued under MRA in accordance with the relevant Part of Schedule 3 of the Therapeutic Goods (Medical Devices) Regulations 2002
Medical
device (non-
IVD) – Class*
Schedule 3 of the Therapeutic Goods (Medical Devices)
Regulations 2002
EC Certificate issued under MDD 93/42/EEC
(Declaration must be made in accordance with
Schedule 3 of the Therapeutic Goods (Medical
Devices) Regulations 2002)
Provided under
TG (MD)
Regulations
Class I
Declaration of Conformity - Part 6 N/A Regulation
3.9(1)
Class Is
Declaration of Conformity - Part 6 plus:
 CAC** Production Quality Assurance - Part 4
 Annex II.3 OR
 Annex V (‘sterility aspects’ or equivalent
wording)
Regulation
3.9(2)
Class Im
Declaration of Conformity - Part 6 plus CAC issued
under either:
 Verification - Part 3 or
 Production Quality Assurance - Part 4 or
 Product Quality Assurance - Part 5
 Annex II.3 or
 Annex IV ( specific batches are included on
the certificate) or
 Annex V or
 Annex VI (‘metrology aspects’ or equivalent
wording)
Regulation
3.9(3)
Class IIa
CAC Full Quality Assurance - Part 1 (excluding clause 1.6
Design Examination) or
Declaration of Conformity - Part 6 plus CAC issued
under either:
 Verification - Part 3 (for non-sterile devices) or
 Production Quality Assurance - Part 4 or
 Product Quality Assurance – Part 5 (for non-sterile
devices)
 Annex II.3 or
 Annex IV (for non-sterile devices where
specific batches are included on the
certificate) or
 Annex V or
 Annex VI (for non-sterile devices)
Regulation 3.8
Session B2: Medical Devices – Accurate Manufacturers Evidence

9. Classification & Conformity Assessment Procedures Required (2)
Medical device
(non-IVD) –
Class*
Schedule 3 of the Therapeutic Goods (Medical Devices)
Regulations 2002
EC Certificate issued under MDD 93/42/EEC
(Declaration must be made in accordance with
Schedule 3 of the Therapeutic Goods (Medical
Devices) Regulations 2002)
Provided under
TG (MD)
Regulations
Class IIb
CAC Full Quality Assurance - Part 1 (excluding clause 1.6
Design Examination) or
CAC Type Examination - Part 2 plus CAC issued under
either:
 Verification - Part 3 (for non-sterile devices) or
 Production Quality Assurance - Part 4 or
 Product Quality Assurance – Part 5 (for non-sterile
devices)
 Annex II.3 or
 Annex III plus either:
 Annex IV (for non-sterile devices where
specific batches are included on the
certificate) or
 Annex V or
 Annex VI (for non-sterile devices)
Regulation 3.7
Class III
CAC Full Quality Assurance - Part 1 (including clause 1.6
Design Examination) or
CAC Type Examination - Part 2 plus CAC issued under
either:
 Verification - Part 3 (for non-sterile devices) or
 Production Quality Assurance - Part 4
 Annex II.3+II.4 or
 Annex III plus either:
 Annex IV (for non-sterile devices where
specific batches are included on the
certificate); or
 Annex V
Regulation 3.6
AIMD
90/385/EEC (AIMDD)
Session B2: Medical Devices – Accurate Manufacturers Evidence

10. Manufacturer Evidence via eBS
• ME Applications:
1. New Manufacturer Evidence
identifier; or
2. Variation to existing
Manufacturer Evidence
identifier.
Session B2: Medical Devices – Accurate Manufacturers Evidence

11. New Manufacturer Evidence Identifier
1. Issued by a recognised Notified Body
(name & Notified Body number)
2. Manufacturer’s name and address
3. Certificate number
4. Annex route & relevant Directive
5. Scope of certificate is listed
6. Issue date / Re-issue date / Expiry date
7. Signature
Assessment of EC Certificate:
Session B2: Medical Devices – Accurate Manufacturers Evidence

12. Attachment/Annex to
EC Certificate checklist:
1. Notified Body (name & Notified
Body number) is the same as EC
Certificate
2. Attachment/Annex lists the
relevant EC Certificate number it
relates to
3. Re-certification date
4. Scope of certificate is listed
5. Signature
Session B2: Medical Devices – Accurate Manufacturers Evidence

13. Variation to Manufacturer Evidence Identifier
• Applications to vary Manufacturer Evidence are
submitted via the TGA’s eBS website
• Variation to Manufacturer Evidence is required when
there have been changes to certificates, including:
- Certificate has expired and re-issued
- Certificate number has changed
- Scope of the certificate has changed
- Conformity assessment procedure changed including
manufacturer’s details
- Manufacturer has changed Notified Body
Session B2: Medical Devices – Accurate Manufacturers Evidence

14. Acceptance of Manufacturer Evidence
• The Sponsor will receive notification in eBS when their
Manufacturer Evidence (new and variation) application is
accepted
• One Manufacturer Evidence can contain one certificate,
the scope of which covers multiple kinds of devices
• Sponsors do not need to include the same certificate under
different Manufacturer Evidence identifier numbers for an
application for ARTG inclusion for all kinds of devices
specified under the scope of that certificate
• The Manufacturer Evidence Identifier is used when
submitting an application for inclusion of a medical device
in the ARTG.
Session B2: Medical Devices – Accurate Manufacturers Evidence

15. Common issues with submitting Manufacturer Evidence
• Two or more Certificates attached to Manufacturer Evidence
– Manufacturer Evidence generally only contains one certificate
• Declaration of Conformity (DoC) made under European
Regulations attached together with Certificate or provided
instead of Certificate
– The TGA is unable to accept Manufacturer Evidence as the DoC must
be made in accordance with the Regulations (not European Directive)
• Incomplete Certificate (e.g. page numbers on certificate
indicate more pages than have been provided)
– These addendum/annex/pages form an integral part of the certificate
as they may provide further information contained in the certificate
Session B2: Medical Devices – Accurate Manufacturers Evidence

16. Common issues (cont.)
• Change of Manufacturer’s name and/or site address
– No Supporting evidence from the notified body that issued the
amended certificate has been attached to the application along with
the updated certificate to determine if the certificate is issued to the
same manufacturer.
• Multiple documentation attached
• Certificates that are not accepted as evidence of
appropriate conformity assessment procedures
– ISO certificates, FDA , EN
– Declaration of Conformity and Design Examination Certificates
should not be provided as Manufacturer Evidence (except
Declaration made in accordance with Clause 7.5 of Schedule 3 of
the Regulations)
Session B2: Medical Devices – Accurate Manufacturers Evidence

17. Common issues (cont.)
• The Certificate provided is not in English
– All documents must be provided in English; proper translation done by
an accredited translator is acceptable
• Information in the application does not reflect the Certificate
– The following details are the most common errors that result in
submission being rejected:
 Incorrect annex route
 Incorrect directive
 Incorrect notified body number selected on application
 Sponsor states ‘scope has not changed’ but it has been found
that the scope of Certificate has changed
• The Certificate has been altered including highlighting, white-
out or adding additional products
– The Certificate needs to be in its original state and all details need to
be shown on the certificate. A watermark is acceptable.
Session B2: Medical Devices – Accurate Manufacturers Evidence

19. Brought to you by:

20. Accurate Manufacturers
Evidence
Milica Talic
Regulatory Affairs Director
Cook Medical Australia
&
Sharyn Roberts
Regulatory Affairs Supervisor
Medtronic Australasia

21. When is Manufacturers Evidence required and when is
it not required?
Manufacturers Evidence is required for Medical Device
Applications for:
• Class 1 Sterile
• Class I Measuring
• Class IIa
• Class IIb
• Class III
• AIMD
Manufacturers Evidence is not required for:
• Class I
• Export Only

22. Examples of Types of Certificates and
associated Manufacturers Evidence
• TGA CA Certificate:
Note: All pages of the supporting documentation must be submitted with the Manufacturers Evidence
eBS Application

23. Examples of Types of Certificates and
associated Manufacturers Evidence
• TGA CA Certificate (cont.):

24. Examples of Types of Certificates and
associated Manufacturers Evidence
Schedule 3 Part 7 Clause 7.5 – System or Procedure Packs

25. Examples of Types of Certificates and
associated Manufacturers Evidence
Schedule 3 Part 7 Clause 7.5 (Cont.)

26. Submitting an Accurate New Manufacturers
Evidence in eBS
Sponsor Reference is
not seen by TGA
This information is
auto filled from log-in
information
The TGA may ask for documentation from the notified body when it is not
clear that the scope of the certificate supports the device under review.

27. Submitting an Accurate New Manufacturers
Evidence in eBS
• To complete your application you must attach an electronic copy of the
supporting document (EC Certificate, TGA Certificate or Declaration of
Conformity)
• Validate your application by clicking the button.
• If there is missing data in the form the validation message will alert you
• If your validation is successful, you may your application

28. Submitting a Variation to Manufacturers
Evidence in eBS
• On the TGA eBS websit after you have logged in go to Medical Device
Evidence
• Find the Evidence that needs to be varied. This can be done by searching
on the Identifier, Expiry Date, User Evidence Name, Availability, NB# or
Sponsor Name.
• Open the Evidence and Create a Variation by clicking
• Confirmation will be given

29. Submitting a Variation to Manufacturers
Evidence in eBS
• Go to your section and locate the variation application.
You will be given the options that may have changed
• If selecting yes you will then be ask
• Select the tick boxes that apply to the change and complete the required
information:

30. Submitting a Variation to Manufacturers
Evidence in eBS
• Attach you supporting documents to the application by clicking the
button
• Complete the required information in the pop-up box and attach your document
• and your application

31. Medical device amendments to
EU-Australia MRA
• The Amended MRA came into force on 1
January 2013
• To allow device manufacturers and
certified bodies time to incorporate the
changes the following transitional
arrangements have been agreed to

32. Medical device amendments to
EU-Australia MRA
• Conformity assessment certificates issued under the current MRA
for medical devices - that will become excluded from the scope of
the MRA by the Amending Agreement - will continue to be valid after
the Amending Agreement comes into force until the certificate expiry
date or 5 years from the date that the Amending Agreement comes
into effect, whichever is earlier.
• Conformity Assessment Bodies that are designated under the
current MRA to issue certificates for medical devices - that will
become excluded from the scope of the MRA by the Amending
Agreement - will be considered to be designated under the
Amending Agreement for the purpose of maintaining such
certificates until the certificate expiry date or 5 years from the date
that the Amending Agreement comes into effect, whichever is earlier.
• Any new conformity assessment certificates issued under the MRA
once the Amending Agreement comes into effect must be issued
according to the provisions of the new Amended Agreement.

33. Some guidance on specific types
of changes
Manufacturer Name Change
TGA FCA Quality Certificate
• Changes require a change request application to update the TGA
Full Quality Assurance Certificate with the new manufacturer
change. Once the changes have been approved the updated
certificate would then be submitted to support the variation to
manufactures evidence.
EC Quality Certificate
• The Sponsor would be required to update the existing evidence by
submitting a variation application, the TGA needs evidence e.g.
audit report to show that this is a change to the name only and the
quality system remains unchanged.

34. Some guidance on specific types
of changes
Manufacturing Address Change
TGA FCA Quality Certificate
• Changes require a change request application to update the TGA Full
Quality Assurance Certificate with the new manufacturer change. Once the
changes have been approved the updated certificate would then be
submitted to support the variation to manufactures evidence.
EC Quality Certificate
• The Sponsor would be required to update the existing evidence by
submitting a variation application, the The sponsor must show the TGA that
there has been no change to the quality system e.g. the factory moves and
the old site is closed or the certificate changes to the companies head office
but the manufacturing site remains unchanged and there are no changes to
the quality system then this is allowed. If it is a new manufacturing site
under a different quality system a new manufacturers evidence would be
required.

35. Some guidance on specific types
of changes
• Devices move from one CE Certificate to
another or the scope of the certificate
changes and no longer covers some
ARTG entries.
This would be considered to be a change in
the ARTG and would need to be submitted
as a device change request.

36. Keeping your Evidence up to date
• You can Export your Manufacturers Evidence information from the
eBS site to a spreadsheet format in either HTML, Excel or XML
formats.
• Each Manufactures Evidence will list the related active ARTG Entry
Information that the evidence supports
• If a manufacturers evidence is no longer required because there are
no active ARTG entries associated you may open the evidence and
the entry.

37. Questions

38. Brought to you by: