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.