Here are the key points regarding fees for inclusion of IVDs in the ARTG: - There is an application fee per application, regardless of the number of devices included in the application. The current fee is $550. - There is an annual charge for inclusion of each kind of device in the ARTG. The current annual charge is $550 per kind of device. - For Viral Diagnostics' products: - There would be 1 application fee of $550 - There are 5 "kinds" of devices: - V-Flu A® and V-Flu B® (same kind) - V-Rhino® - V-RSV® - Sample purification kit

2. Session C1 – IVDs
Applications for inclusion of IVDs
in the ARTG
Submitting the Perfect Application
Euan Miller
Assistant Director, Application and Verification Section
Office of Devices Authorisation, TGA
Sponsor Information and Training Day - 9 September 2014

3. Legislation
• The Therapeutic Goods Act 1989 (the Act)
• The Therapeutic (Medical Devices) Regulations
2002 (the Regulations)
• The Therapeutic Goods (excluded purposes)
Specifications 2010
• The Therapeutic Goods Advertising Code 2007
Session C1 – Applications for inclusion of IVDs in the ARTG

4. IVD Medical Devices
• Definition for MD provided by s41BD of the Act
• Definition of IVD provided by the Regulations
(Dictionary)
Session C1 – Applications for inclusion of IVDs in the ARTG

5. What is an IVD?
• A reagent, calibrator, control material, kit, specimen
receptacle, instrument, software, equipment or system
• Intended for the in vitro examination of human specimens
for
- giving information about a physiological or pathological
state
- giving information about a congenital abnormality
- determining safety and compatibility with a potential
recipient
- monitoring therapeutic measures
[Therapeutic Goods (Medical Devices) Regulations 2002]
Session C1 – Applications for inclusion of IVDs in the ARTG

6. Types of IVD
• Intended to be used by:
- health professionals in the laboratory
- health professionals at the point of care
- lay-person (self-testing)
• Does not include Research Use Only (RUO) or Analyte
Specific Reagents (ASR)
• Intended purpose: from the manufacturer and NOT the
sponsor – instructions for use.
Session C1 – Applications for inclusion of IVDs in the ARTG

7. IVD Framework and Transitional
Arrangements
• Commenced 1 July 2010
• Supply prior to 1 July 2010 – transitional
• Supply post 1 July 2010 – not transitional
• Transitional arrangements for ARTG inclusion end:
- 31 August 2014 (TGA CA)
- 30 June 2015 (class 1-3)
- 30 June 2017 (in-house class 1-3)
Session C1 – Applications for inclusion of IVDs in the ARTG

8. Regulatory Framework
• Kind of device
- Sponsor/manufacturer
- Classification
- GMDN
- unique product identifier (UPI)
(Class 4 IVD)
• Conformity assessment procedures
• Essential principles
• ARTG (inclusion)
• Post-market monitoring
• Fees and charges
Session C1 – Applications for inclusion of IVDs in the ARTG

9. Application Process
• eBS Account (sponsor)
• Client registration (manufacturer)
• Manufacturer Evidence
• Application
• Audit (when and if required)
• Decision to include or not to include the device
Session C1 – Applications for inclusion of IVDs in the ARTG

10. ARTG Process
Session C1 – Applications for inclusion of IVDs in the ARTG

11. Manufacturer Evidence
• TGA Conformity Assessment Certificate (Class 4 IVD)
• IVDD 98/79/EC (European Council Notified Body)
• ISO 13485 from:
- A certified body that is also a Notified Body designated
under the IVDD 98/79/EC
- CMDCAS recognised registrar (Health Canada)
- IAF
FOR THE KIND OF DEVICE (Scope of the Certificate)
Session C1 – Applications for inclusion of IVDs in the ARTG

12. Requirements for Applications
• Intended purpose consistent
• Correct classification
• Appropriate GMDN term
• Appropriate Manufacturer Evidence
• Matters certified are correct
Session C1 – Applications for inclusion of IVDs in the ARTG

13. Most Common Issues
1. Classification incorrect
2. Intended purpose
3. IVD Name and Category
4. Kind of device
5. Declaration of conformity
6. Systems
7. Procedure packs that include both MD (not IVD) and IVD
8. Attachments
Session C1 – Applications for inclusion of IVDs in the ARTG

14. IVD Framework
• Four tier classification system based on different levels of
risk for each class of IVD
• All IVDs to comply with a set of Essential Principles for
quality safety and performance
• Provision for post-market monitoring
• Transitional arrangements
Session C1 – Applications for inclusion of IVDs in the ARTG

15. Classification of IVDs
• Schedule 2A of the Regulations
• Eight rules (1.1 – 1.8) based on intended purpose and risk
associated with the device
• 4 Classes
• Manufacturer’s responsibility
• Guidance available (TGA web-site)
Session C1 – Applications for inclusion of IVDs in the ARTG

16. Rule 1.3 of Schedule 2A
• Rule 1.3 (2) – NNDSS
• Rule 1.3 (1)(g) human genetic testing
• Rule 1.3 (1)(f)
- (i) selective therapy and management
- (ii) for disease staging
- (iii) in the diagnosis of cancer
Note for paragraph (f): An IVD medical device would fall
into Class 2 IVD under Clause 1.7 if
(a) a therapy decision would usually be made only after further
investigation; or
(b) the device is used for monitoring
Session C1 – Applications for inclusion of IVDs in the ARTG

17. GMDN Terms
• Global Manufacturer Device Nomenclature (GMDN) term
• 3 levels of collective term (CT) and a single preferred term
• Classification dependent
• Manufacturer’s responsibility
• Guidance available (TGA internet site)
Session C1 – Applications for inclusion of IVDs in the ARTG

18. GMDN Example 1
• 30832 HIV1/HIV2 antigen IVD, kit,
immunochromatographic test (ICT) rapid
• Human immunodeficiency viruses (HIV) IVDs [CT284]
• Viral Infectious disease IVDs [CT355]
• Infectious disease IVDs [CT701]
Session C1 – Applications for inclusion of IVDs in the ARTG

19. GMDN Example 2
• 30225 Multiple urine analyte IVD, kit, colourimetric dipstick,
rapid
• Urine screening IVDs [CT1246]
• Clinical chemistry biological screening IVDs [CT1236]
• Clinical chemistry IVDs [CT287]
Session C1 – Applications for inclusion of IVDs in the ARTG

20. GMDN Example 3
• 30854 Glucose monitoring system IVD, home use/point-of-
care
• No relevant level 3 CT
• Clinical chemistry substrate IVDs [CT833]
• Clinical chemistry IVDs [CT287]
Session C1 – Applications for inclusion of IVDs in the ARTG

21. Intended Purpose
• Based on manufacturer’s intended purpose (information
provided with the device, including IFU)
• Appropriate for the kind of device (specific versus general)
• Should be consistent with GMDN term and description
• 500 characters only in the application
Session C1 – Applications for inclusion of IVDs in the ARTG

22. IVD Name and Category
• Device Product Characteristics (including self-testing,
POCT, etc)
• Name of device (labelling and packaging)
• ALL devices must be identified
Session C1 – Applications for inclusion of IVDs in the ARTG

23. Application for a kind of device
• s41BE of the Act
• One application for a kind of device
• Examples:
- System 1: BGMS (including strips) + test strips + controls
(same kind of device)
- System 2: BGMS (excluding strips) + test strips +
controls (NOT same kind of device)
*BGMS blood glucose monitoring system
Session C1 – Applications for inclusion of IVDs in the ARTG

24. Declarations of Conformity (DoC)
• When to be provided:
- Class 3 IVDs – with application
- Application audits
• DoC ONLY made in accordance with Australian regulations
• Templates available
• Part 5 of Schedule 3 of the Regulations
• Clauses 1.8, 4.7, 6.6 and 7.5
• Certificate number for accepted ME and DoC (aligned)
Session C1 – Applications for inclusion of IVDs in the ARTG

25. IVD Procedure Packs
• Section 41BF of the Act
- intended to be used as a unit
• Regulation 3.3 of the Regulations - Principles for applying
the classification rules
• Reg. 3.3 (9) - highest classification
• Reg. 3.3 (10) - if same classification then primary intended
purpose
Session C1 – Applications for inclusion of IVDs in the ARTG

26. Systems
• Systems Vs devices supplied individually
• Separate ARTG inclusions
(i.e. separate applications for ARTG inclusion)
(unless same kind of device)
- instrument Vs consumables
Session C1 – Applications for inclusion of IVDs in the ARTG

27. Attachments
• DoC – mandatory for Class 3 only - YES
• QMS certificates – already linked to the
application as manufacturer evidence - NO
• Health Canada licence(s) - YES
• IFU/Manuals/Brochures - NO
Session C1 – Applications for inclusion of IVDs in the ARTG

28. Selection of Application for Audit
• s41FH(1)(a) of the Act – must select
- Regulation 5.3(1)(j) of the Regulations
- 8 kinds of devices
• s41FH(1)(b) of the Act – may select
- Device Product Characteristics
- Other information provided in and with the
application
Session C1 – Applications for inclusion of IVDs in the ARTG

29. Accessing the TGA for Guidance and
for Regulatory Requirements
• www.tga.gov.au
Session C1 – Applications for inclusion of IVDs in the ARTG

30. Medical Devices and IVDs
Session C1 – Applications for inclusion of IVDs in the ARTG

31. Standards, Guidelines and Publications
Session C1 – Applications for inclusion of IVDs in the ARTG

33. eBS Applications and the
Application Process
Hiram Chipperfield
Regulatory Affairs Manager
Alere

34. Disclaimer
All opinions are my own and do not represent the views of my employer
or the TGA.

35. Viral Diagnostics, Inc., USA
(Fictitious case-study)
• Developed a novel viral diagnostic technology
• Recently FDA cleared
• Test Cassettes:
– V-Flu A®
– V-Flu B®
– V-Rhino® (Common cold)
– V-RSV®
• Sample purification kit - for use with V-RSV®
• V-Analyser® an instrument that analyses the test cassettes
– Printer
– Connectivity Pack

36. Australian Viral Diagnostics Team
CEO Marketing Guy Regulatory Colleague

37. Set up eBS Account

38. Manufacturer’s Evidence

40. Manufacturer’s Evidence

41. Manufacturer’s Evidence - Search for
Manufacturer

42. eBS@tga.gov.au
New manufacturer [SEC=UNCLASSIFIED

43. Manufacturer’s Evidence - Types of
Certification
Viral Diagnostics Inc. (United States of America) [12345]
1 Main St New York NY 10044 United States of America [123456]

44. Manufacturer’s Evidence - Types of
Certification
Certification issued under Conformity assessment procedure IVD Class
TGA Conformity Assessment
Certification (IVDs)*
Schedule 3 Part 1
(Full Quality Assurance)
Class 4
Class 3
Class 2
TGA Conformity Assessment
Certification (IVDs)*
Schedule 3 Part 4
(Production Quality Assurance)
Class 4
Class 3
Class 2
Directive 98/79/EC (IVDD)
Annex IV.3
(Full Quality Assurance)
Class 3
Class 2
Directive 98/79/EC (IVDD)
Annex VII
(Production Quality Assurance)
Class 3
Class 2
CMDCAS ISO 13485 Certification ISO 13485 Manufacturing and Design
Class 3
Class 2
CMDCAS ISO 13485 Certification ISO 13485 Manufacturing excluding Design Class 2
Other ISO 13485 Certification ISO 13485
Class 3
Class 2

45. Manufacturer’s Evidence - Certificate
Details

46. Manufacturer’s Evidence - Attach
Certificate

47. Manufacturer’s Evidence - Review and
Submit
eBS@tga.gov.au
Decision on Manufacturer Evidence ‘Viral
Diagnostics Inc' [SEC=UNCLASSIFIED]

48. Device Application

49. Device Application: V-Flu A®

50. Device Application - Same Kind of
Devices
In the case of Class 1, Class 2,
Class 3 IVDs, one IVD is
considered to be of the "same kind"
as another IVD, if both devices:
• have the same legal
manufacturer
• have the same sponsor
• are the same classification
• have the same GMDN code

51. Device Application - Same Kind of
Devices
Product IVD Class
V-Flu A® 2
V-Flu B® 2
V-Rhino® (Common cold) 2
V-RSV® 2
Sample purification kit -
for use with V-RSV® 2
V-Analyser® 2
Printer 2
Connectivity Pack 2
Class 2 IVD low public health risk
or moderate
personal risk

52. Device Application - Same Kind of
Devices
Product IVD Class
V-Flu A® 3
V-Flu B® 3
V-Rhino® (Common cold) 2
V-RSV® 2
Sample purification kit -
for use with V-RSV® 2
V-Analyser® 1
Printer N/A
Connectivity Pack 1

53. Device Application - GMDN
Product IVD Class GMDN
V-Flu A® 3
V-Flu B® 3
V-Rhino® (Common cold) 2
V-RSV® 2
Sample purification kit -
for use with V-RSV® 2
V-Analyser® 1
Connectivity Pack 1

54. Device Application - GMDN
Option 1
• Download “The use of
GMDN Codes for IVD
medical devices in
Australia”
• Control + F (find):
“influenza”
Option 2
• Search Function in eBS
– Class of device affects
search results
– Search “IVDs” for all
options

55. Device Application - GMDN
Option 1

56. Device Application - GMDN
Product IVD Class GMDN
V-Flu A® 3 CT732 Influenza virus IVDs
V-Flu B® 3 CT732 Influenza virus IVDs
V-Rhino® (Common
cold)
2 CT355 Viral infectious disease IVDs
V-RSV® 2 CT355 Viral infectious disease IVDs
Sample purification kit -
for use with V-RSV® 2 CT355 Viral infectious disease IVDs
V-Analyser® 1 CT943 Instrument/analyser IVDs
Connectivity Pack 1 CT943 Instrument/analyser IVDs

57. Device Application - Same Kind of
Devices
Product IVD Class GMDN
V-Flu A®
3 CT732 Influenza virus IVDs
V-Flu B®
V-Rhino® (Common cold)
2
CT355 Viral infectious disease
IVDs
V-RSV®
Sample purification kit -
for use with V-RSV®
V-Analyser®
1 CT943 Instrument/analyser IVDs
Connectivity Pack

58. Device Application - HTA Questions

59. Device Application - Intended Use

60. Device Application - Intended Use
Insert application form picture
Product Intended Use
V-Flu A®
V-Flu B®
V-Rhino® (Common cold)
V-RSV®
Sample purification kit -
for use with V-RSV®
V-Analyser®
Connectivity Pack

61. Device Application - Intended Use
IVDs intended to be used as an
aid in the rapid diagnosis of
influenza A or influenza B in the
laboratory or at the point of
care.
IVDs intended to aid in the
diagnosis of influenza viral
infections.

62. Device Application - Intended Use
Insert application form picture
Product Intended Use
V-Flu A®
IVDs intended to aid in the diagnosis of
influenza viral infections.V-Flu B®
V-Rhino® (Common cold)
IVDs intended to aid in the diagnosis of viral
infectious diseases.
V-RSV®
Sample purification kit -
for use with V-RSV®
V-Analyser®
Instruments intended to be used as in vitro
diagnostics.Connectivity Pack

63. Device Application - Product
Characteristic Questions

64. Device Application - Product
Characteristic Questions

65. Device Application - Product
Characteristic Questions

66. Device Application - Product
Characteristic Questions
What about V-RSV®?

67. Device Application - Manufacturer’s
Evidence and GMDN Code

68. Device Application - Summary

69. Device Application Declaration
How much will this cost?

70. Device Application - Business Rules
Business rule 1(a):
If more than one application
includes IVDs that are required to
undergo a mandatory TFR and
the contents of the STED are
applicable to IVD(s) from each
application, then the fees may be
reduced. The full prescribed fee
will apply to one application, and
reduced fees applied to any
subsequent application(s).
Effective applications for inclusion
in the ARTG must be received by
the TGA on the same day; the
IVDs must have the same
sponsor and manufacturer; and
be similar in nature.
Business rule 1(b):
If a single application includes
more than one IVD that is subject
to a mandatory TFR, then the
TGA will select one or more
products from the range of IVDs
covered by that application to
undergo detailed review. One
TFR fee will apply per application.

71. Device Application - Business Rules
Product
IVD
Class
Fee
V-Flu A®
3 ~$6,000
V-Flu B®
V-Rhino® (Common cold)
2 ~$2,000V-RSV®
Sample purification kit - for
use with V-RSV®
V-Analyser®
1 ~$2,000
Connectivity Pack

72. Device Application - Attachments

73. Device Application - Submission
Second person to
review application

74. Device Application - Submission
Save a copy of the
application

75. Device Application - Submission
• Application fee is payable after submission
• Application “not visible” to TGA until fee is paid
• TGA will review application and send Technical File Request and
Technical file review invoice (if required)

77. Session C1 – IVDs
Applications and the application
process
Peter Kaylock
Office of Devices Authorisation
Therapeutic Goods Administration
Sponsor Information and Training Day - 9 September 2014
Software as an IVD

78. Legislation covering software as an IVD
• Therapeutic Goods (Medical Devices) Regulations 2002
– Regulation 1.3 Definitions – the dictionary
– IVD medical device means:
 a reagent, calibrator, control material … software
 Intended by the manufacturer to be used in vitro for:
• Giving information about a physiological or pathological state …
Session C1 – Software as an IVD

79. Intended purpose
• The intended purpose of the software determines whether:
– It is an IVD
– Classification – Class 1, 2, 3 or 4 IVD
– Regulatory requirements
• Intended purpose found in one or more of labelling, IFU, advertising
material, technical documentation
Session C1 – Software as an IVD

80. Guidelines
• Software as in vitro diagnostic medical devices (IVDs)
published on TGA website
www.tga.gov.au/industry/ivd-software.htm
• Classification of IVD medical devices at
www.tga.gov.au/industry/ivd-classification.htm
Session C1 – Software as an IVD

81. Instrument software
• Software as in vitro diagnostic medical devices (IVDs) published
on TGA website www.tga.gov.au/industry/ivd-software.htm
• Classification of IVD medical devices at
www.tga.gov.au/industry/ivd-classification.htm
Session C1 – Software as an IVD

82. Diagnostic or therapeutic software
• Software intended to provide diagnostic or therapeutic information
– Standalone software for the interpretation of a series of results in order to
determine foetal risk of trisomy 21
– Standalone software for use in staging or predicting severity of disease using
an algorithm combining anthropometric measures and bio-markers
 Class 3 IVDs under rule 1.3
Session C1 – Software as an IVD

83. Software that is not an IVD
• Software intended for receiving, transferring, storing patient-related
information including results from IVDs:
– Laboratory Information Management Systems
– Middleware
– Conversion, compression and encryptions tools for transmitting
information between devices or systems
Session C1 – Software as an IVD

84. Can a LIMS be an IVD?
• LIMS which include functionality to generate new diagnostic or
therapeutic information that is not the result of another IVD(s) would
be a software IVD
• Classified by the manufacturer (commercial or in-house) according to
the intended purpose and classification rules
• TGA is reviewing guidelines on what constitutes ‘new’ diagnostic or
therapeutic information, e.g. converting units of measure
Session C1 – Software as an IVD

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