Session C3 - IVDs: Post-market responsibilities (I) Presented by: Sally Jennings, RA QA Affairs & IBP Manager, Abbott Diagnostics Myriam Battistutta, Senior Consultant, Quality & Regulatory Affairs, Fusidium Irina Tsyganova, Director, Devices Application & Verification, Office of Devices Authorisation, TGA

2. Session C3 - IVDs
Post-market responsibilities (I)
ARTG Inclusion Maintenance
Euan Miller
Device Application and Verification Section
Office of Device Authorisation
Sponsor Information & Training Day – 9 September 2014

3. Section 9A of the Therapeutic Goods
Act 1989
• Australian Register of Therapeutic Goods (ARTG)
• Information in the ARTG in relation to a kind of medical
device should be complete and correct.
Session C3: IVDs - Post-market responsibilities (I)

4. Session C3: IVDs Post-market responsibilities (I)
Section 9D of the Act –
Variation of entries in ARTG
• Following request from the sponsor
- Subsection 9D(1) - if the entry contains information that
is incomplete or incorrect
- Subsection 9D(3C) - if variation would be to reduce the
class of persons for whom the kind of device is suitable, or
to add a warning, restriction or precaution
- Subsection 9D(3D) - if variation does not indicate any
reduction in the quality, safety or performance of the kind
of medical device for the purposes for which it is to be
used

5. Session C3: IVDs Post-market responsibilities (I)
Kind of device
• ARTG entry is for a kind of medical device
- section 41BE - Kind of medical device
• A medical device is taken to be of the same kind as another medical
device if devices have the same:
- sponsor
- manufacturer
- device nomenclature system code - refer Regulation 1.7
- medical device classification, and
- other characteristics as the Regulations prescribe - unique product
identifier (UPI) given to the device by its manufacturer to identify the
device and any variants (Class 4 IVD medical device, other than an
immunohaematology reagent IVD medical device) - refer Regulation 1.6

6. Evidence of application of appropriate conformity
assessment procedure to the kind of device
• ARTG Certificate provides the manufacturer’s name
and address, and reference to the Manufacturer
Evidence (ME)
• When this information is changed the sponsor needs
to request the TGA to vary this information on the
ARTG.
Session C3: IVDs Post-market responsibilities (I)

7. Information about the manufacturer
• Manufacturer of a medical device is the person who is
responsible for the design, production, packaging and
labelling of the kind of device before it is supplied under
the person’s name (section 41BG of the Act)
• If manufacturer by the meaning above is changed, the
current ARTG entry cannot be varied, and an
application for a new ARTG inclusion of a kind of device
should be submitted.
Session C3: IVDs Post-market responsibilities (I)

8. Variation Pathways
• Device Change Request – to change information
entered on the ARTG
• Variation - addition of new device(s) of the same
kind (standard condition of ARTG inclusion)
• Notification about transfer of the sponsorship.
Session C3: IVDs Post-market responsibilities (I)

9. Device Change Request
• Intended purpose / functional description
• Name of device (if specified on ARTG certificate)
• Manufacturer information (name, address, etc)
• Sponsor information (name, address, etc)
• Manufacturer evidence identifier.
Session C3: IVDs Post-market responsibilities (I)

10. ARTG Inclusion Standard Condition
• Devices that require an application audit under
Regulation 5.3 if subject to a separate application for entry in
the ARTG cannot be included under the same ARTG entry
until a request to vary the entry has been submitted and
approved by the TGA.
Session C3: IVDs Post-market responsibilities (I)

11. Information Required
• Based on the change required and/or the device(s) to be included under
the same ARTG entry
• May include:
- Instructions for use
- Validation of performance characteristics
- Clinical evidence
- Lay-user studies
- Manufacturer or sponsor specific information
- Information from the Notified Body or ISO 13485 certification body
Session C3: IVDs Post-market responsibilities (I)

12. Information about the sponsor
• Regulation 10F of the Therapeutic Goods
Regulations 1990
- provides circumstances when the person in
relation to whom a medical device is included in
the ARTG is changed
Session C3: IVDs Post-market responsibilities (I)

13. Information about the sponsor (cont.)
• Regulation 10F provides that if:
(1) a sponsor (a person) dies, the legal personal representative
(2) a sponsor becomes bankrupt, the trustee in bankruptcy of the
estate of the bankrupt
(3) a sponsor (a body corporate) is wound up, the liquidator of the body
corporate
(4A) a sponsor transfers or assigns, in whole or in part, the business to
which the kind of device relates or the sponsor’s interest in the
device, the person to whom the business or interest is transferred
or assigned is taken to be the sponsor
(4) sponsor changes his/her/its name and the TGA is notified of a new
name, the TGA must enter the new name in the ARTG as the name
of the sponsor
Session C3: IVDs Post-market responsibilities (I)

14. Information about the sponsor (cont.)
• The sponsor must notify the TGA in writing within 3 months of the
event
• The sponsor must be able to provide sufficient evidence required to
establish the matter if requested by the TGA
• Regulation 10F does not place any other requirements on the TGA
Session C3: IVDs Post-market responsibilities (I)

15. Transfer of Sponsorship
• Requires a variation to the ARTG entry
• Requires the notification of the transfer of sponsorship
(through a different process pathway)
• Manufacturer Evidence to be submitted by accepting
sponsor
Session C3: IVDs Post-market responsibilities (I)

16. • Sponsors should consider if TGA should be notified
when manufacturers implement any changes in relation
to the kinds of devices included in the ARTG
Session C3: IVDs Post-market responsibilities (I)

18. Brought to you by:

20. Post-market responsibilities (I)
ARTG inclusion maintenance
Sally Jennings
RA QA Affairs and IBP Manager
Abbott Diagnostics

21. What information may be able to be
changed in an ARTG entry?
• Sponsor’s name and postal address
• Manufacturer’s name and address
• Manufacturer’s Evidence Identifier (except Class 1 IVDs)
• Device classification (e.g. Class 1,Class 2, Class 3, Class 4 IVD)
• GMDN code and term
• Manufacturer’s intended purpose
• Unique Product Identifier (UPI) (Class 4 IVD medical devices only)
• Functional description
• List of products covered by an ARTG entry for an IVD medical
device that are subject to mandatory application audit
• Unique ARTG number (assigned by TGA)
• ARTG start date (assigned by TGA)
• Conditions applying automatically under section 41FN of the Act
• Additional conditions imposed at the time of entry or after entry in
the ARTG under sections 41FO or 41FP of the Act respectively
(assigned by TGA)

22. Client Details
• Client details must be kept up to date as part of
maintaining ARTG entries
• Can be used to update Sponsor or Manufacturer details

23. Change of Sponsor Name and/or address
Acme Enterprises New Age Enterprises
Acme Enterprises Acme Enterprises
50 Second Rate Ave,
Melbourne
1 Top Dog Ave, Melbourne
• Acme needs to:
• Change Client Details
ARTG entries will be updated with new name and/or
address once Client Details changed

24. Changes to an ARTG entry
• https://www.ebs.tga.gov.au/
• ‘Forms’ to use:
- Notification about transfer of sponsor
- IVD Variation Application
- Device Change Request
- Variation to Manufacturer Evidence
“Which form do I use for my change?”

25. Fees
• Fee ($410*) is per ARTG entry
– Not changes to Manufacturers Evidence and Client Details
• ‘Transfer of Sponsor’ form
– all ARTG entries on one form
• ‘IVD Variation’ and ‘Device Change Request’ forms
– one form per ARTG entry
*2014/15 financial year

26. CHANGES TO OTHER
SPONSOR INFORMATION

27. Transfer of Sponsor Form
• Transfer of distribution rights (sponsor)
• Death, bankruptcy or winding up of
corporation
• Change of Business Entity, ie ABN change

28. Transfer of Sponsor
• Relinquishing Sponsor and
Accepting Sponsor must
complete forms
– Requires Cooperative transfer
– Accepting Sponsor accepts ALL
responsibility for the ARTG
entry/entries
• Must be able to provide
evidence supporting the
change
– certificate of death
– deed of agreement
– sales contract
http://www.tga.gov.au/about/forms-transfer-sponsor.htm#.U_V6y51--
Uk

29. Transfer of Sponsor cont
• Accepting Sponsor must
resubmit Manufacturers
Evidence
• List all ARTG entries and
pay a fee to transfer
– $410 per ARTG entry
• Sponsors have 3 months
to notify TGA of transfer

30. Transfer of Sponsor cont

31. CHANGES TO MANUFACTURER
INFORMATION

32. New Manufacturer Certification
Fuji Inc.
75 Shijo Road, Kyoto
• New certificate with same scope
– Full Conformity Assessment Certification (Annex IV, Part 1) for
the same ‘kinds of devices’
• Same name and address
• Same Quality Management System!!!
Variation to Manufacturers Evidence

33. Change of Manufacturer Name and/or
address
Fuji Inc. Kyoto Inc.
Fuji Inc.
Fuji Inc.
1 Gojo Road, Kyoto 75 Shijo Road, Kyoto
Same Quality Management System!!!!
Variation to Manufacturers Evidence
Device Change Request

34. Variation to
Manufacturers Evidence
• https://www.ebs.tga.gov.au/
• Select Medical Device Evidence
Select Evidence to be
changed

35. Variation to Manufacturers Evidence
• Select ‘Create Variation’
• A Draft of the M/E is
created in the ‘Drafts’
section of eBS
Fuji Inc EU AoC
Acme Enterprises
John Brown
Fuji Incorporated
75 Shijo Road, Kyoto
This certification is to support an application for an in vitro diagnostic medical
device (IVD)
Directive 98/79/EC (IVDD)
Annex IV.3
Underwriters Laboratories
123456
30/09/2010
30/09/2014
None
Full Quality Assurance Certificate.
Note: For Class 3 IVDs an Australian Declaration of Conformity must be
submitted with the Device Application.
EC Certificate - AOC Expiry 30/09/2010
Id(s). ARTG Entry Name(s).
987654 – Acme Enterprises – Prostate Specific Antigen IVDs
123456 – Acme Enterprises – Hepatitis B IVDs
DV-2014-MC-10051-3

36. • Request ‘New Manufacturer’ if name
and/or address unknown to TGA
Variation to Manufacturers Evidence
DV-2014-MC-10051-3

37. • Attach supporting information
for the change
– New certificate
– Declaration letter from company
affirming change is only in name
and/or address or other evidence
where required
Variation to Manufacturers Evidence

38. Device Change Request form
• Caution:
– One ARTG entry per
Request
– Print before submission
– Once submitted request
is no longer visible
– Printout will only show
what can be seen on
screen in the
‘Description’ box
Variation to Manufacturer name:
Manufacturer name change from Fuji Inc. to Kyoto Inc.
Manufacturers Evidence: DV-2014-MC-10051-3 updated with new
certificate to support change.

39. Manufacturer Acquisition
• Case Study 1
– Paris Ltd is bought by Acme Ltd
– Paris Ltd changes both name and address
– Paris Ltd keeps it’s own unchanged quality system
– European IVDD Certificate maintains same scope
– An updated certificate is issued by the notified body to Acme
Paris Ltd at the new address
Variation to Manufacturers Evidence
Device Change Request
Paris Ltd
Acme Ltd
Buys Acme Paris Ltd
1 Champs-Elyses
10 Louvre Ave

40. Manufacturer Acquisition
Great Wall
Enterprises
Grand Canyon Inc
Buys Grand Canyon China
• Case Study 2
– Great Wall Enterprises is bought by Grand Canyon Inc
– Great Wall becomes Grand Canyon China
– Grand Canyon China is now covered by Grand Canyon
Inc Quality Management System
– Grand Canyon Inc is listed as the Legal Manufacturer
New ‘Kind of Device’ – new ARTG entry

41. Case Study 3
Australian Manufacturer/Sponsor
• Acme Enterprises is an Australian manufacturer and a sponsor
• Acme needs to:
• Notify TGA of Substantial change to Conformity Assessment
Certification, and
• Change Client Details, and
• Update Manufacturers Evidence, and
• Variation to ARTG Entry – Device Change Request Form
Acme Enterprises New Age Enterprises
50 Second Rate Ave,
Melbourne
1 Top Dog Ave, Melbourne

42. OTHER INFORMATION

43. Other information
• Intended purpose, functional description or Unique
Product Identifier (UPI) (Class 4 IVD only)
• Example 1:
• Acme Company has a current ARTG entry for an
influenza IVD ‘kind of device’:
– Product category: Medical Device Included – IVD Class 3
– GMDN: CT732
– GMDN Term: Influenza virus IVDs
– Intended Purpose states – ‘for the detection of Influenza virus in
whole blood samples’
• New product for detection of Influenza B in serum
samples
– Need to change intended purpose to include serum samples
Device Change Request Form

44. Device Change Request form
• Caution:
– One ARTG entry per
Request
– Print before submission
– Once submitted request
is no longer visible
– Printout will only show
what can be seen on
screen in the
‘Description’ box

45. • Example 2
• Acme Company has a current ARTG entry for a
Hepatitis B IVD ‘kind of device’:
– Product category: Medical Device Included – IVD Class 4
– GMDN: 48303
– GMDN Term: Hepatitis B virus core immunoglobulin M (IgM)
antibody IVD, kit, enzyme immunoassay
• Intended Purpose states:
– ‘An enzymatic immunoassay for the determination of
antibodies to Hepatitis B core in clinical specimens’
Other Information

46. • Example 2 cont
• Acme wants to change intended purpose to include a
cadaveric claim
• New intended purpose:
– ‘An enzymatic immunoassay for the determination of antibodies to
Hepatitis B core in clinical specimens, including specimens
collected post-mortem (non-beating heart)’
• Acme will need to notify TGA of ‘Substantial Change to
TGA Conformity Assessment Certificate’ first
– Change to Intended Purpose of a Class 4 assay
• When the updated Conformity Assessment Certificate is
issued………
Device Change Request Form
Other Information

47. Device Change Request form
• Note:
– Just reference relevant
Design Examination
certificate

48. Standard Conditions
• Standard Condition of entry onto ARTG
– Written on all IVD ARTG certificates
• ‘Goods which would require an application audit under Regulation 5.3 if subject to a
separate application for entry in the Register cannot be included under this ARTG entry
until a request to vary the entry has been submitted and approved by the TGA.’
– Products required to undergo mandatory Application Audit are listed under
Regulation 5.3 (1)(j)
• Does not apply to ‘kinds of devices covered by TGA Conformity Assessment Certificate
– These products are listed on the ARTG certificate
• Except those covered by 5.3 (1)(j)(viii)
– To supply any additional product (goods) covered by Regulation 5.3 (1)(j) under
an existing ARTG entry TGA must be notified first
• Example
• ARTG entry for CC Influenza IVDs used for POC testing
• Lists ‘Acme POC Influenza A and B test’
• Company XYZ wants to launch an additional product ‘Acme Influenza test for POC
Instrument ABC’
IVD Variation Form

49. IVD Variation Form
Example for training day
Company XYZ
John Smith
John.smith@xyz.com

50. IVD Variation Form
Class 3
Company XYZ
Influenza virus IVDs (CT732)
Example for training day
Company XYZ
John Smith
John.smith@xyz.com

51. IVD Variation Form
Acme POC Influenza A and B test
Acme POC Influenza A and B test

52. IVD Variation Form
Company XYZ
Example for training day
Class 3
Influenza virus IVDs
Company XYZ
234 Express way, Busytown
Influenza virus IVDs (CT732)
IVDs intended to aid in the diagnosis of influenza A and B viral infections
Company XYZ
test for training Day
Class 3
Influenza virus IVDs (CT732)
• Attach Labelling and IFU as
supporting information

53. IVD Variation Form
Company XYZ
Example for training day
Class 3
Influenza virus IVDs
Company XYZ
234 Express way, Busytown
Influenza virus IVDs (CT732)
IVDs intended to aid in the diagnosis of influenza A and B viral infections
No
Company XYZ
test for training Day
Class 3
Influenza virus IVDs (CT732)
• Attach list of additional products
• Attach Labelling and IFU as
supporting information

54. CASE STUDIES

55. Brought to you by:

57. Post-market responsibilities (I)
ARTG inclusion maintenance
Myriam Battistutta
Snr Consultant Quality & Regulatory
Fusidium

58. Agenda
• Case Study 1 – interesting variation
• Case Study 2 – change to a ‘system’
• Managing Approved Manufacturer’s
Evidence

59. Case Study 1

60. Case Study 1
• Company XYZ has a current ARTG entry
for an influenza (POC) diagnostic.
• Visual read, lateral flow IVD
– Product category: Medical Device Included –
IVD Class 3
– GMDN: CT732
– GMDN Term: Influenza virus IVDs
– Intended purpose: IVDs intended to aid in the
diagnosis of influenza A and B viral infections

61. Case Study 1
Company wants to supply an additional
POC influenza virus POC IVD from the
same manufacturer.
• Assay cartridge read on dedicated instrument
Is a variation request required?

62. Case Study 1
Same Sponsor? Yes
Same Manufacturer? Yes
Same Class? Yes
Same GMDN? Yes
Falls within scope of current ME? Yes
POC or self-testing IVD? Yes*
*Specific products are listed on the ARTG
Certificate therefore will need to apply for
variation to add the new product.

63. Case Study 1
However…….
Because the new IVD POC assay:
1. Requires the dedicated instrument to generate a result, and
2. The sponsor does not have a current ARTG entry for IVD
instrument (Class1) for this manufacturer, then…
A new inclusion application needs to be submitted for the
instrument.

64. Case Study 1
Because instrument is used for POC test –
mandatory TF review requested.
Fee: $6,330.00 for application audit (TF review).
May want to consider a request for reduction in
fee based on certain aspects of the POC test
already having been reviewed under existing
entry – best to consult with TGA.

65. Case Study 2

66. Case Study 2
Company ABC is both Sponsor and Manufacturer of
an ARTG Entry for a ‘system’. The ‘system’ contains:
• POC instrument (IVD MD Class 1) from manufacturer D
• POC lateral flow test strips (IVD MD Class 2) – from manufacturer D
• Lancets – MD Class IIa from manufacturer E
• Collection capillary tubes – IVD MD Class 1 from manufacturer F
Classification of system is IVD Medical Device Class 2

67. Case Study 2
Company ABC has used the Clause 7.5 special
conformity assessment procedures to support this
system ARTG entry & therefore has used their
Australian Declaration of Conformity as
Manufacturer’s Evidence.
This DOC lists contents of System, but not specific
manufacturer information of each component.

68. Case Study 2
Manufacturer E can no longer supply their
lancets and a new manufacturer (F) now
supplies lancets for the system.
What does the Sponsor need to do when this
change occurs?

69. Case Study 2
For changes to contents of Systems or
Procedure Packs the manufacturer must first
ask the following questions:
• Has the overall classification changed?
• Has the GMDN changed?
No to both in this case study.
(Note: if yes to either/both: need to submit new ARTG Entry application.
E.g. If Class 3 IVD lateral flow cartridge added to system -> overall classification changes)

70. Case Study 2
• Company ABC does not need to submit any
request for change or variation request to
TGA.
• However, other action is necessary
• Company ABC must obtain the appropriate CA
evidence from the new lancet supplier to enable
Company ABC’s existing ME (Australian DoC) to
remain true & correct.
• Must occur before changing to new lancet supplier.

71. Manufacturer’s Evidence
Managing shelf-life…

72. Click on ‘Medical Device Evidence’
under ‘Your TGA Information’ to
access list of accepted ME & expiry
dates of each.
• No notification from TGA of impending expiry.
• You need your own system for alerts.
• Allow some lead time before expiry to get the
updated certificates from the manufacturer.
• If evidence expires it won’t be available for use in
support of another application.

73. Brought to you by: