For the purpose of this survey, an in vitro diagnostic device (IVD)
refers to any instrument, equipment or apparatus, reagent (alone or in
combination) or control/calibrator, which is intended to be used in
vitro for the examination of a specimen derived from the human body.
Types of IVDs in the market
6.
Please ensure your responses to this survey reflect only the
operations of the business to whom this survey is addressed.
General Information / Demographics
2
3
4
5
6
7
8
With respect to IVDs, please indicate which activities apply to your
business? (You may tick more than one box)
1
2
3
Local manufacturing
Distributing of locally manufactured products
Importing and distributing of your own company’s products
(i.e. proprietary products)
4
Importing and distributing of another company’s products
(i.e. third party products)
5
3.
Exporting
Does your business have an overseas parent or overseas
subsidiary/s?
Yes
No
1
4.
2
3
4
5
3
10 or less
11-20
21-50
51-100
More than 100
For the last financial year, what was the range of your business’s
total annual turnover?
1
2
3
4
5
6
7
5b
2
How many employees does your business have in Australia?
1
5a
Don’t know
Less than $250,000
$250,000 - $1,000,000
$1,000,001 - $5,000,000
$5,000 001 - $10,000,000
$10,000,001- $25,000,000
$25,000,001- $50,000,000
More than $50,000,000
7a
5d
Locally manufactured:
B.
Imported IVDs:
B.
Bacteriology/microbiology
C.
Histopathology
D.
Biochemistry
E.
Cytopathology
F.
Serology
G.
Immunology
H.
Molecular genetics
I.
Biochemical genetics
J.
Transfusion medicine
K.
Endocrinology
L.
Other
Low volume refers to products that are only marginally profitable
for your business, due to a small number of tests sold or very low
margins per unit sold.
Does your business offer for supply, IVDs that you would consider
to be low volume?
What approximate percentage of your turnover related to the sale
of IVDs was from a) locally manufactured IVDs, b) imported IVDs
A.
Haematology
For example, if you were required to list all IVDs that you offer for
supply in Australia with the TGA, you might consider withdrawing
low volume IVDs from the market because the costs of listing may
mean these IVDs are no longer profitable.
What approximate percentage of this turnover was from the sale of
IVDs?
%
5c
A.
Imported third
party
QLD
NT
WA
SA
1
Imported
proprietary
TAS
VIC
ACT
NSW
2.
For example, if all of the IVDs you offer for supply in
Australia were required to be listed with the Therapeutic
Goods Administration (TGA), how many products would you
need to list in each of the following categories?
In which state or territory is your business located?
Locally
Manufactured
1.
How many IVDs (please refer to the definition at the top of this survey)
do you currently offer for supply in Australia in each of the
following categories, including those that are a) locally
manufactured and b) imported, for both proprietary and third
party products? (NB: Proprietary refers to products you import from
your own company and third party refers to products you import from
another company)
Yes
%
1
No
(Go to Q8)
2
Don’t know
(Go to Q8)
3
%
100%
7b
How many IVDs that you manufacture or distribute (as identified
in Question 6) would you consider to be low volume?
7c
For those products you consider to be low volume, what is the
average number of tests sold per month?
What approximate percentage of your turnover related to the sale
of IVDs, was from IVDs you export from Australia?
%
8.
What percentage of your total sales from IVDs, do home use
IVDs contribute?
14.
%
For the last financial year, what approximate percentage of your
exports of IVDs manufactured in Australia (by value of sales) were
destined for each of the following markets?
Impact of regulatory proposal
9.
Go to Question 16 if you do not export IVDs manufactured in
Australia.
Go to Question 10 if you do not manufacture IVDs in Australia.
Of the total number of IVDs that you manufacture in Australia (as
identified in Question 6) how many of these IVDs are a) registered, b)
listed or c) not registered or listed with the TGA?
A.
United States
%
B.
Canada
%
C.
European Union (see NB in Q12 above)
%
D.
Other (Please specify below)
%
No. of IVDs
Total 100%
A. Registered in Australia:
B. Listed in Australia:
C. Not registered or listed in Australia:
10.
Go to Question 11 if you do not import proprietary IVDs.
Of the total number of IVDs that you import from your own
company (as identified in Question 6), how many of these
IVDs are a) registered, b) listed or c) not registered or listed
with the TGA in Australia?
No. of IVDs
A. Registered in Australia:
B. Listed in Australia:
C. Not registered or listed in Australia:
11.
Go to Question 12 if you do not import third party IVDs.
Of the total number of IVDs that you import from another
company (as identified in Question 6) how many of these IVDs are
a) registered, b) listed or c) not registered or listed with the
TGA in Australia?
No. of IVDs
A. Registered in Australia:
B. Listed in Australia:
C. Not registered or listed in Australia:
12.
Go to Question 14 if you do not import IVDs.
Please identify the source countries of the IVDs that your
business imports. (Please tick all boxes that apply)
1
2
3
4
5
A.
B.
C.
D.
E.
United States
Canada
European Union (see NB below)
Asia
Other
NB: European Union refers to: Austria, Belgium, Denmark, Finland, France,
Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands, Portugal,
Spain, Sweden, & United Kingdom.
13.
In the last financial year, what approximate percentage of your
total sales from IVDs did imported IVDs, which are registered or
listed with regulatory bodies in the US, European Union or
Canada contribute?
(When thinking about the Europe Union please include all IVDs that will need
to be registered or listed from December 2003)
%
15.
What approximate percentage of the locally manufactured
IVDs that you export are a) registered and b) listed with the
TGA in Australia?
A. Registered in Australia:
B. Listed in Australia:
%
%
In the proposed new regulatory framework, the responsibility for
IVD risk classification will lie with manufacturers, who will
classify their products using a set of rules. The TGA will then
confirm or revise the risk class upon receipt of the application.
The TGA has proposed that there be four risk classes (see
below), and that a given IVD’s risk classification will determine
the requirements to be met prior to its supply on the Australian
market, with requirements increasing as risk level increases.
Class I represents the lowest risk class, while Class IV
represents the highest risk class.
16. Go to Question 17 if you do not manufacture IVDs.
Looking at the total number of IVDs that you manufacture in
Australia (as reported in Question 6), please estimate what
approximate percentage of these IVDs fall into each of the
following proposed risk classes:
Class IV - High public health risk
E.g. IVDs used to screen blood or tissue donations etc.
for the presence of serious disease causing or lifethreatening pathogens.
Class III – High personal risk / Moderate public
health risk
E.g. IVDs used in the diagnosis of rubella infection in
pregnancy, IVDs for the detection of some cancer
markers.
Class II – Low public health risk / Moderate personal
risk
E.g. IVDs for pregnancy testing, thyroid stimulating
hormone, etc.
Class I – No public health risk / Low personal risk
E.g. Media used to identify or infer the identity of a
micro-organism, IVD instrumentation.
Total
%
%
%
%
100 %
17.
Go to Question 18 if you are a manufacturer only
20.
Looking at the total number of IVDs that you distribute in
Australia (but do not manufacture), please estimate what
approximate percentage of these IVDs fall into each of the
following proposed risk classes:
Class IV - High public health risk
E.g. IVDs used to screen blood or tissue donations etc.
for the presence of serious disease causing or lifethreatening pathogens.
Class III – High personal risk / Moderate public
health risk
E.g. IVDs used in the diagnosis of rubella infection in
pregnancy, IVDs for the detection of some cancer
markers.
Class II – Low public health risk / Moderate personal
risk
E.g. IVDs for pregnancy testing, thyroid stimulating
hormone, etc.
Class I – No public health risk / Low personal risk
E.g. Media used to identify or infer the identity of a
micro-organism, IVD instrumentation.
Total
18.
Go to Question 21 if you are a manufacturer only
For those IVDs you distribute but do not manufacture, if
required, could you obtain and provide evidence of
compliance with quality system requirements from the
manufacturer? (For example, ISO 13485/13488, EN 46001/46002
etc)
NB: Quality system requirements are standards relating to the design,
manufacture, packaging, labelling, storage, installation and servicing of
finished products.
%
1
Don’t know
2
No
%
3
4
%
5
%
100 %
Go to Question 19 if you do not manufacture IVDs in Australia.
6
21.
For those IVDs that you manufacture, if there was a requirement
for performance and safety data to be reviewed prior to supply,
could you provide this data for those IVDs likely to fall into the
proposed Class III or Class IV risk categories (i.e. high personal or
high public risk)?
Go to Question 22 if you do not manufacture IVDs in
Australia
For those IVDs you manufacture, if required, could you
demonstrate compliance with formal quality system
requirements? (For example, ISO 13485/13488, EN 46001/46002 etc)
NB: Quality system requirements are standards relating to the design,
manufacture, packaging, labelling, storage, installation and servicing of
finished products.
Performance and safety data refers to sufficient valid scientific evidence that
provides reasonable assurance that the device is safe and effective for its
intended uses(s).
Don’t know
1
1
Don’t know
No
2
2
No
I could obtain performance and safety data for less than
25% of these IVDs
3
3
4
4
5
6
19.
I could provide evidence of compliance for less than
25% of IVDs distributed
I could provide evidence of compliance for 25%-50%
of IVDs distributed
I could provide evidence of compliance for 51%-75%
of IVDs distributed
I could provide evidence of compliance for more than
75% of IVDs distributed
I could obtain performance and safety data for 25%-50% of
these IVDs
5
6
I could obtain performance and safety data for 51%-75% of
these IVDs
I could obtain performance and safety data for more than
75% of these IVDs
22.
For those IVDs that you distribute (but do not manufacture), if there
was a requirement for performance and safety data to be reviewed
prior to supply, could you obtain this data from the manufacturer,
for those IVDs likely to fall into the proposed Class III or Class IV
risk categories (i.e. high personal or high public risk)?
2
3
4
5
6
No
I could obtain performance and safety data for less than
25% of these IVDs
I could obtain performance and safety data for 25%-50% of
these IVDs
I could obtain performance and safety data for 51%-75% of
these IVDs
I could obtain performance and safety data for more than
75% of these IVDs
Go to Question 23 if you are a manufacturer only
If required, what approximate percentage of the
manufacturers you purchase IVDs from, could you direct to
modify their IVD product labelling or generate Australian
specific labelling?
Go to Question 21 if you are a manufacturer only.
Performance and safety data refers to sufficient valid scientific evidence that
provides reasonable assurance that the device is safe and effective for its
intended uses(s)
1
Don’t know
I could provide demonstrate compliance for less than
25% of IVDs distributed
I could demonstrate compliance for 25%-50% of IVDs
distributed
I could demonstrate compliance for 51%-75% of IVDs
distributed
I could demonstrate compliance for more than 75% of
IVDs distributed
%
23.
What approximate percentage of the total number of IVDs
that you manufacture or distribute do you currently
undertake post-market monitoring? (e.g. to track product failures,
recalls etc)
%
In its discussion paper (see front cover), the TGA has
proposed options for a new framework for the regulation of
the supply of IVDs in the Australian market.
24a
In what ways do you think the current arrangements by which
the TGA regulates the supply of IVDs in the Australian market
could be improved?
24b
What do you think would be the major impacts of the TGA’s
proposals for a higher level of regulatory oversight of the
supply of IVDs in the Australian market?
26.
Approximately how long did this questionnaire take you to
complete?
Hours
Minutes
Thank-you for assisting us with this survey.
PLEASE RETURN YOUR COMPLETED SURVEY FORM
TO PIAZZA CONSULTING IN THE REPLY PAID
ENVELOPE PROVIDED BY DATE.
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Woden ACT 2606
Ph: (02) 6282 4963
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