Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulation 2014
Select Legislative Instrument No. 62, 2014
I, General the Honourable Sir Peter Cosgrove AK MC (Ret’d), Governor‑General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following regulation.
Dated 29 May 2014
Peter Cosgrove
Governor‑General
By His Excellency’s Command
Fiona Nash
Assistant Minister for Health
Contents
1............ Name of regulation.............................................................................. 1
2............ Commencement................................................................................... 1
3............ Authority............................................................................................. 1
4............ Schedule(s)......................................................................................... 1
Schedule 1—Amendments 2
Therapeutic Goods (Medical Devices) Regulations 2002 2
Therapeutic Goods Regulations 1990 3
1 Name of regulation
This regulation is the Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulation 2014.
2 Commencement
This regulation commences on 1 July 2014.
3 Authority
This regulation is made under the Therapeutic Goods Act 1989.
4 Schedule(s)
Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.
Schedule 1—Amendments
Therapeutic Goods (Medical Devices) Regulations 2002
1 Amendments of listed provisions
Amendments of fees
Item
Provision
Omit
Substitute
1
Paragraph 9.4(2)(b)
3 620
3 705
2
Schedule 5, item 1.1
900
920
3
Schedule 5, item 1.2, paragraph (a)
7 780
7 965
4
Schedule 5, item 1.2, paragraph (b)
7 830
8 020
5
Schedule 5, item 1.3, paragraph (a)
47 700
48 800
6
Schedule 5, item 1.3, paragraph (b)
36 700
37 600
7
Schedule 5, item 1.3A, paragraph (a)
26 900
27 500
8
Schedule 5, item 1.3A, paragraph (b)
57 300
58 700
9
Schedule 5, item 1.3A, paragraph (c)
14 000
14 300
10
Schedule 5, item 1.3A, paragraph (d)
3 380
3 460
11
Schedule 5, item 1.3A, paragraph (e)
37 000
37 900
12
Schedule 5, item 1.3A, paragraph (f)
23 600
24 200
13
Schedule 5, item 1.5, paragraphs (a) and (b)
1 180
1 210
14
Schedule 5, item 1.5, paragraphs (c) to (f)
920
940
15
Schedule 5, item 1.7
16 400
16 800
16
Schedule 5, item 1.8
320
330
17
Schedule 5, item 1.9, paragraph (a)
26 800
27 400
18
Schedule 5, item 1.9, paragraph (b)
52 700
54 000
19
Schedule 5, item 1.9, paragraph (c)
36 700
37 600
20
Schedule 5, item 1.9, paragraph (d)
25 600
26 200
21
Schedule 5, item 1.9, paragraph (e)
23 400
24 000
22
Schedule 5, item 1.9, paragraph (f)
20 000
20 500
23
Schedule 5, item 1.9A, paragraph (a)
26 900
27 500
24
Schedule 5, item 1.9A, paragraph (b)
57 300
58 700
25
Schedule 5, item 1.9A, paragraph (c)
14 000
14 300
26
Schedule 5, item 1.9A, paragraph (d)
3 380
3 460
27
Schedule 5, item 1.9A, paragraph (e)
37 000
37 900
28
Schedule 5, item 1.9A, paragraph (f)
23 600
24 200
29
Schedule 5, item 1.10, paragraph (a)
16 100
16 500
30
Schedule 5, item 1.10, paragraph (b)
31 700
32 500
31
Schedule 5, item 1.10, paragraph (c)
22 100
22 600
32
Schedule 5, item 1.10, paragraph (d)
14 000
14 300
33
Schedule 5, item 1.10, paragraph (e)
12 100
12 400
34
Schedule 5, item 1.12
370
380
35
Schedule 5, item 1.13
3 460
3 545
36
Schedule 5, item 1.14
6 350
6 500
37
Schedule 5, item 1.14A
6 180
6 330
38
Schedule 5, item 1.15
400
410
39
Schedule 5, item 1.17
920
940
40
Schedule 5, paragraph 2.1(b)
370
380
Therapeutic Goods Regulations 1990
2 Amendments of listed provisions
Amendments of fees etc.
Item
Provision
Omit
Substitute
1
Paragraph 43AAJ(1)(b)
88 400
90 500
2
Paragraph 45(4A)(a)
9 860
10 095
3
Paragraph 45(4A)(b)
8 200
8 395
4
Paragraphs 45(4A)(c) and (ca)
7 930
8 120
5
Paragraph 45(4A)(d)
33 000
33 800
6
Paragraphs 45(4A)(e) and (f)
7 930
8 120
7
Paragraphs 45(9)(a) to (e)
4 930
5 050
8
Paragraphs 45(11)(a) to (e)
1 800
1 845
9
Regulation 45A
15 000
15 500
10
Schedule 9, Part 2, item 1A
420
430
11
Schedule 9, Part 2, item 1, paragraph (a)
1 560
1 595
12
Schedule 9, Part 2, item 1, paragraph (b)
19 400
19 900
13
Schedule 9, Part 2, item 1, paragraph (c)
16 400
16 800
14
Schedule 9, Part 2, item 1, paragraph (d)
2 470
2 530
15
Schedule 9, Part 2, item 2, paragraph (a)
1 410
1 445
16
Schedule 9, Part 2, item 2, paragraph (b)
1 320
1 350
17
Schedule 9, Part 2, item 2, paragraph (ba)
43 200
44 200
18
Schedule 9, Part 2, item 2, paragraph (bb)
14 400
14 700
19
Schedule 9, Part 2, item 2, paragraph (bc)
28 800
29 500
20
Schedule 9, Part 2, item 2, paragraph (bd)
25 700
26 300
21
Schedule 9, Part 2, item 2, subparagraph (be)(i)
8 570
8 775
22
Schedule 9, Part 2, item 2, subparagraph (be)(ii)
5 590
5 725
23
Schedule 9, Part 2, item 2, subparagraph (bf)(i)
17 200
17 600
24
Schedule 9, Part 2, item 2, subparagraph (bf)(ii)
11 200
11 500
25
Schedule 9, Part 2, item 2, paragraph (bg)
16 600
17 000
26
Schedule 9, Part 2, item 2, paragraph (bh)
2 720
2 785
27
Schedule 9, Part 2, item 2, paragraph (bi)
16 800
17 200
28
Schedule 9, Part 2, item 2, paragraph (bj)
990
1 015
29
Schedule 9, Part 2, item 2, paragraph (c)
3 930
4 025
30
Schedule 9, Part 2, item 2, paragraph (d)
1 970
2 015
31
Schedule 9, Part 2, item 2, paragraph (d)
11 400
11 700
32
Schedule 9, Part 2, item 2, paragraph (f)
620
635
33
Schedule 9, Part 2, item 2, paragraph (g)
1 320
1 350
34
Schedule 9, Part 2, item 2, paragraph (h)
660
675
35
Schedule 9, Part 2, item 2AA
600
615
36
Schedule 9, Part 2, item 2A, paragraph (a)
1 520
1 555
37
Schedule 9, Part 2, item 2A, paragraph (b)
1 410
1 445
38
Schedule 9, Part 2, item 2A, paragraph (c)
370
380
39
Schedule 9, Part 2, item 2A, paragraphs (d) to (g)
400
410
40
Schedule 9, Part 2, item 2AB
380
390
41
Schedule 9, Part 2, item 2AC
990
1 015
42
Schedule 9, Part 2, item 2B
4 930
5 050
43
Schedule 9, Part 2, item 2C
3 940
4 035
44
Schedule 9, Part 2, item 2CA
4 930
5 050
45
Schedule 9, Part 2, item 3, paragraph (a)
400
410
46
Schedule 9, Part 2, item 3, paragraph (b)
740
760
47
Schedule 9, Part 2, item 3AA
600
615
48
Schedule 9, Part 2, item 3AB
150
155
49
Schedule 9, Part 2, item 4, paragraph (a)
173 000
177 200
50
Schedule 9, Part 2, item 4, subparagraphs (aa)(i) and (ii)
57 700
59 100
51
Schedule 9, Part 2, item 4, subparagraph (aa)(iii)
115 200
118 000
52
Schedule 9, Part 2, item 4, paragraph (b)
102 800
105 300
53
Schedule 9, Part 2, item 4, subparagraph (bb)(i)
34 300
35 100
54
Schedule 9, Part 2, item 4, subparagraph (bb)(i)
22 200
22 700
55
Schedule 9, Part 2, item 4, subparagraph (bb)(ii)
34 300
35 100
56
Schedule 9, Part 2, item 4, subparagraph (bb)(ii)
22 200
22 700
57
Schedule 9, Part 2, item 4, subparagraph (bb)(iii)
68 500
70 100
58
Schedule 9, Part 2, item 4, subparagraph (bb)(iii)
44 700
45 800
59
Schedule 9, Part 2, item 4, paragraph (c)
66 000
67 600
60
Schedule 9, Part 2, item 4, paragraph (d)
10 900
11 200
61
Schedule 9, Part 2, item 4, paragraph (g)
66 900
68 500
62
Schedule 9, Part 2, item 4, paragraph (h)
3 940
4 035
63
Schedule 9, Part 2, item 5, paragraph (a)
9 440
9 665
64
Schedule 9, Part 2, item 5, subparagraph (b)(i)
9 440
9 665
65
Schedule 9, Part 2, item 5, subparagraph (b)(ii)
12 100
12 400
66
Schedule 9, Part 2, item 5, subparagraph (b)(iii)
16 600
17 000
67
Schedule 9, Part 2, item 5, subparagraph (b)(iv)
22 000
22 500
68
Schedule 9, Part 2, item 5, subparagraph (b)(v)
33 000
33 800
69
Schedule 9, Part 2, item 5, subparagraph (b)(vi)
44 000
45 100
70
Schedule 9, Part 2, item 5, subparagraph (b)(vii)
66 000
67 600
71
Schedule 9, Part 2, item 5, paragraph (c)
3 410
3 490
72
Schedule 9, Part 2, item 5, subparagraph (d)(i)
3 410
3 490
73
Schedule 9, Part 2, item 5, subparagraph (d)(ii)
12 100
12 400
74
Schedule 9, Part 2, item 5, subparagraph (d)(iii)
16 600
17 000
75
Schedule 9, Part 2, item 5, subparagraph (d)(iv)
22 000
22 500
76
Schedule 9, Part 2, item 5, subparagraph (d)(v)
33 000
33 800
77
Schedule 9, Part 2, item 5, subparagraph (d)(vi)
44 000
45 100
78
Schedule 9, Part 2, item 5, subparagraph (d)(vii)
66 000
67 600
79
Schedule 9, Part 2, item 5A, paragraphs (a) to (f)
4 930
5 050
80
Schedule 9, Part 2, item 5B
16 400
16 800
81
Schedule 9, Part 2, item 6, paragraph (a)
28 900
29 600
82
Schedule 9, Part 2, item 6, paragraphs (b), (c) and (ca)
19 700
20 200
83
Schedule 9, Part 2, item 6, paragraph (d)
33 000
33 800
84
Schedule 9, Part 2, item 6AA
350
360
85
Schedule 9, Part 2, item 6AB
620
635
86
Schedule 9, Part 2, item 6ABA
1 870
1 915
87
Schedule 9, Part 2, item 6AC
1 050
1 075
88
Schedule 9, Part 2, item 6AD, paragraph (a)
19 700
20 200
89
Schedule 9, Part 2, item 6AD, paragraph (b)
4 930
5 050
90
Schedule 9, Part 2, item 6A
1 320
1 350
91
Schedule 9, Part 2, item 6B
3 300
3 380
92
Schedule 9, Part 2, item 6C
7 180
7 350
93
Schedule 9, Part 2, item 6D, paragraph (a)
9 440
9 665
94
Schedule 9, Part 2, item 6D, paragraph (b)
12 100
12 400
95
Schedule 9, Part 2, item 6D, paragraph (c)
16 600
17 000
96
Schedule 9, Part 2, item 6D, paragraph (d)
22 000
22 500
97
Schedule 9, Part 2, item 6D, paragraph (e)
33 000
33 800
98
Schedule 9, Part 2, item 6D, paragraph (f)
44 000
45 100
99
Schedule 9, Part 2, item 6D, paragraph (g)
66 000
67 600
100
Schedule 9, Part 2, item 7, paragraph (a)
9 860
10 095
101
Schedule 9, Part 2, item 7, paragraphs (b), (c) and (ca)
8 200
8 395
102
Schedule 9, Part 2, item 7, paragraph (d)
33 000
33 800
103
Schedule 9, Part 2, item 7, paragraphs (e) and (f)
8 200
8 395
104
Schedule 9, Part 2, item 7A, paragraph (a)
9 440
9 665
105
Schedule 9, Part 2, item 7A, subparagraph (b)(i)
9 440
9 665
106
Schedule 9, Part 2, item 7A, subparagraph (b)(ii)
12 100
12 400
107
Schedule 9, Part 2, item 7A, subparagraph (b)(iii)
16 600
17 000
108
Schedule 9, Part 2, item 7A, subparagraph (b)(iv)
22 000
22 500
109
Schedule 9, Part 2, item 7A, subparagraph (b)(v)
33 000
33 800
110
Schedule 9, Part 2, item 7A, subparagraph (b)(vi)
44 000
45 100
111
Schedule 9, Part 2, item 7A, subparagraph (b)(vii)
66 000
67 600
112
Schedule 9, Part 2, item 7B, paragraph (a)
9 440
9 665
113
Schedule 9, Part 2, item 7B, subparagraph (b)(i)
9 440
9 665
114
Schedule 9, Part 2, item 7B, subparagraph (b)(ii)
12 100
12 400
115
Schedule 9, Part 2, item 7B, subparagraph (b)(iii)
16 600
17 000
116
Schedule 9, Part 2, item 7B, subparagraph (b)(iv)
22 000
22 500
117
Schedule 9, Part 2, item 7B, subparagraph (b)(v)
33 000
33 800
118
Schedule 9, Part 2, item 7B, subparagraph (b)(vi)
44 000
45 100
119
Schedule 9, Part 2, item 7B, subparagraph (b)(vii)
66 000
67 600
120
Schedule 9, Part 2, item 8
920
940
121
Schedule 9, Part 2, item 9, paragraph (a)
600
615
122
Schedule 9, Part 2, item 9, paragraph (b)
1 220
1 250
123
Schedule 9, Part 2, item 9AA
600
615
124
Schedule 9, Part 2, item 9AB
810
830
125
Schedule 9, Part 2, items 9AC and 9ACA
600
615
126
Schedule 9, Part 2, item 9AD, paragraph (a)
1 180
1 210
127
Schedule 9, Part 2, item 9AD, paragraph (b)
10 200
10 400
128
Schedule 9, Part 2, item 9AD, paragraph (c)
22 700
23 200
129
Schedule 9, Part 2, item 9AD, paragraph (d)
30 500
31 200
130
Schedule 9, Part 2, item 9AD, paragraph (e)
47 600
48 700
131
Schedule 9, Part 2, item 9AD, paragraph (f)
63 300
64 800
132
Schedule 9, Part 2, item 9AD, paragraph (g)
77 100
79 000
133
Schedule 9, Part 2, items 9B and 9C
16 400
16 800
134
Schedule 9, Part 2, item 10
150
155
135
Schedule 9, Part 2, items 14 and 14A
320
330
136
Schedule 9, Part 2, item 17, subparagraph (a)(i)
220
225
137
Schedule 9, Part 2, item 17, subparagraph (a)(ii)
270
275
138
Schedule 9, Part 2, item 17, subparagraph (a)(iii)
420
430
139
Schedule 9, Part 2, item 17, subparagraph (a)(iv)
110
115
140
Schedule 9, Part 2, item 17, paragraph (b)
190
195
141
Schedule 9, Part 2, item 17, paragraph (c)
110
115
142
Schedule 9, Part 2, item 17A, subparagraph (a)(i)
1 080
1 105
143
Schedule 9, Part 2, item 17A, subparagraph (a)(ii)
570
585
144
Schedule 9, Part 2, item 17A, sub‑subparagraph (a)(iii)(A)
810
830
145
Schedule 9, Part 2, item 17A, sub‑subparagraph (a)(iii)(B)
230
235
146
Schedule 9, Part 2, item 17A, subparagraph (a)(iv)
390
400
147
Schedule 9, Part 2, item 17A, subparagraph (a)(v)
280
285
148
Schedule 9, Part 2, item 17A, sub‑subparagraph (a)(vi)(A)
220
225
149
Schedule 9, Part 2, item 17A, sub‑subparagraph (a)(vi)(B)
270
275
150
Schedule 9, Part 2, item 17A, sub‑subparagraph (a)(vi)(C)
420
430
151
Schedule 9, Part 2, item 17A, paragraph (b)
190
195
152
Schedule 9, Part 2, item 18
1 990
2 040
153
Schedule 9A, Part 2, items 1, 2 and 3
980
1 005
154
Schedule 9A, Part 2, item 4
65 200
66 800
155
Schedule 9A, Part 2, item 5
130 400
133 500
156
Schedule 9A, Part 2, item 6
211 900
217 000
157
Schedule 9A, Part 2, item 7
21 100
21 600
158
Schedule 9A, Part 2, item 8
980
1 005
159
Schedule 9A, Part 2, item 9
5 980
6 125
160
Schedule 9A, Part 2, item 10
15 700
16 100
161
Schedule 9A, Part 2, item 11
31 000
31 700
162
Schedule 9A, Part 2, item 12
19 400
19 900
163
Schedule 9A, Part 2, item 13
14 700
15 100
164
Schedule 9A, Part 2, item 14
600
615
165
Schedule 9A, Part 2, item 16
23 500
24 100
166
Schedule 9A, Part 2, item 17
310
315
