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Therapeutic Goods (Medical Devices) Amendment Regulations 2011 (No. 2)

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Therapeutic Goods (Medical Devices) Amendment Regulations 2011 (No. 2)1
Select Legislative Instrument 2011 No. 104
I, QUENTIN BRYCE, Governor-General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following Regulations under the Therapeutic Goods Act 1989.
Dated 16 June 2011
QUENTIN BRYCE
Governor-General
By Her Excellency’s Command
CATHERINE KING
Parliamentary Secretary for Health and Ageing
1              Name of Regulations
                These Regulations are the Therapeutic Goods (Medical Devices) Amendment Regulations 2011 (No. 2).
2              Commencement
                These Regulations commence on 1 July 2011.
3              Amendment of Therapeutic Goods (Medical Devices) Regulations 2002
                Schedule 1 amends the Therapeutic Goods (Medical Devices) Regulations 2002.
Schedule 1        Amendments
(regulation 3)
 
[1]           Before regulation 8.1
insert
8.1A        Matters for which information and documents can be requested
                For paragraph 41JA (j) of the Act, the following matters are prescribed:
                (a)    whether the devices are medical devices;
               (b)    whether the devices are intended for a specified purpose, as ascertained under subsection 41BD (2) of the Act;
                (c)    whether the devices are correctly classified under Division 3.1 of Part 3;
               (d)    whether procedures are in place, including a written agreement with the manufacturer of the devices, that require the manufacturer to make available information mentioned in paragraph 41FD (e) or (g) of the Act;
                (e)    whether the devices contain substances that are prohibited imports under the Customs Act 1901;
                (f)    whether the devices are to be used exclusively for one or more of the purposes specified under section 41BEA of the Act;
               (g)    the accuracy and completeness of information included in or with the application.
[2]           Schedule 3A, clause 11
omit
destroy the devices.
insert
direct a person, other than the person who has control over the devices, to destroy the devices in the way directed.
[3]           Table of amendments — fees
Provision
omit each mention of
insert

Paragraph 9.4 (2) (b)
$3 220
$3 330

Schedule 5, item 1.1
790
820

Schedule 5, item 1.2
6 920
7 160

Schedule 5, item 1.2
6 970
7 210

Schedule 5, item 1.3
42 500
43 900

Schedule 5, item 1.3
32 700
33 800

Schedule 5, item 1.3A
23 900
24 700

Schedule 5, item 1.3A
51 000
52 700

Schedule 5, item 1.3A
12 500
12 900

Schedule 5, item 1.3A
3 010
3 110

Schedule 5, item 1.3A
33 000
34 100

Schedule 5, item 1.3A
21 000
21 700

Schedule 5, item 1.5
1 050
1 090

Schedule 5, item 1.5
810
840

Schedule 5, item 1.7
14 600
15 100

Schedule 5, item 1.8
280
290

Schedule 5, item 1.9
23 800
24 600

Schedule 5, item 1.9
46 900
48 500

Schedule 5, item 1.9
32 700
33 800

Schedule 5, item 1.9
22 800
23 600

Schedule 5, item 1.9
20 800
21 500

Schedule 5, item 1.9
17 800
18 400

Schedule 5, item 1.9A
23 900
24 700

Schedule 5, item 1.9A
51 000
52 700

Schedule 5, item 1.9A
12 500
12 900

Schedule 5, item 1.9A
3 010
3 110

Schedule 5, item 1.9A
33 000
34 100

Schedule 5, item 1.9A
21 000
21 700

Schedule 5, item 1.10
14 300
14 800

Schedule 5, item 1.10
28 200
29 200

Schedule 5, item 1.10
19 700
20 400

Schedule 5, item 1.10
12 500
12 900

Schedule 5, item 1.10
10 800
11 200

Schedule 5, item 1.12
330
340

Schedule 5, item 1.13
3 080
3 180

Schedule 5, item 1.14
5 650
5 840

Schedule 5, item 1.14A
5 500
5 690

Schedule 5, item 1.15
360
370

Schedule 5, item 1.17
810
840

Schedule 5, paragraph 2.1 (b)
$330
$340

Note
1.       All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003. See http://www.frli.gov.au.