Commonwealth Numbered Regulations Commonwealth Numbered Regulations[1] Schedule 3, Part 2, after item 7
insert
8 | control material for use with diagnostic goods for in vitro use |
[2] Schedule 9, item 2, column 2
omit
application to which item 2AA applies):
insert
application to which item 2AA or 3A applies):
[3] Schedule 9, after item 3AA
insert
3A | Application fee for paragraph 23 (2) (a) of the Act for registration of a therapeutic device to which item 5 of Part 1 of Schedule 3 applies (if the application is not an application to which item 2AA applies) | The fee applicable under paragraph 2 (c) or (d) for an application of that nature |
3B | Evaluation fee for subsection 24 (1) of the Act for a therapeutic device to which item 5 of Part 1 of Schedule 3 applies, if the evaluation is for: | |
(a) the device | The fee applicable under item 6 for an evaluation of that nature | |
(b) a document setting out animal toxicological information about the medicinal component of the device |
The fee applicable under paragraph 4 (b) for an evaluation of that nature | |
(c) a document setting out the chemistry, quality control and manufacturing information of the medicinal component of the device | The fee applicable under paragraph 4 (c) for an evaluation of that nature |
[4] Schedule 9, item 5A, after paragraph (e)
insert
(f) control material for use with diagnostic goods for in vitro use | 3 400 |
[5] Schedule 9, item 6, column 2
omit
in respect of a therapeutic device to which Part 1 of Schedule 3 applies
insert
in respect of a therapeutic device to which any of items 1
to 4 of Part 1 of Schedule 3 applies
[6] Schedule 9, item 7, column 2
omit
a change to a therapeutic device to which Part 1 of Schedule 3 applies where the evaluation
insert
a change to a therapeutic device to which any of items 1 to 4 of Part 1 of Schedule 3 applies, if the evaluation
[7] Schedule 9, after item 7
insert
7AA | Fee for evaluation of data submitted in support of a change to a therapeutic device to which item 5 of Part 1 of Schedule 3 applies, if the evaluation involves review of: | |
(a) the device (not including the medicinal component of the device) | The fee applicable under item 7 for an evaluation of that nature | |
(b) the medicinal component of the device | The fee applicable under paragraphs 4 (b), 4 (c) and 7 (d) for an evaluation of that nature | |
(c) the device (including the medicinal component of the device) | The fee applicable under paragraphs 4 (b) and 4 (c), and item 7, for an evaluation of that nature |
[8] Schedule 9, item 9A
omit
[9] Schedule 9, item 15
omit
[10] Further amendments — regulation 45
Provision | omit | insert |
|---|---|---|
Paragraph (4A) (a) | $6 000 | $6 800 |
Paragraphs (4A) (b), (c) and (ca) | $5 000 | $5 670 |
Paragraph (4A) (d) | $20 000 | $22 670 |
Paragraphs (4A) (e) and (f) | $5 000 | $5 670 |
Paragraphs (9) (a), (b), (c), (ca), (d) and (e) | $3 000 |
$3 400 |
Paragraphs (11) (a), (b), (c), (ca), (d) and (e) |
$1 000 | $1 140 |
[11] Further amendments — Schedule 9, column 3
Provision | omit | insert |
|---|---|---|
Item 1A | 260 | 280 |
Item 1, paragraph (a) |
1 170 | 1 240 |
Item 1, paragraph (b) | 14 390 | 15 300 |
Item 1, paragraph (c) | 10 660 | 11 330 |
Item 1, paragraph (d) |
1 600 | 1 700 |
Item 2, paragraph (a) | 690 | 730 |
Item 2, paragraph (b) | 850 | 900 |
Item 2, paragraph (ba) | 5 330 | 5 670 |
Item 2, paragraph (c) | 2 560 | 2 720 |
Item 2, paragraph (d) |
1 280 | 1 360 |
Item 2, paragraph (d) | 7 460 | 7 930 |
Item 2, paragraph (f) | 290 | 310 |
Item 2, paragraph (g) | 850 | 900 |
Item 2, paragraph (h) | 430 | 460 |
Item 2AA | 580 | 620 |
Item 2A, paragraph (a) |
530 | 560 |
Item 2A, paragraph (b) | 690 | 730 |
Item 2A, paragraph (c) | 210 | 220 |
Item 2A, paragraph (d) | 430 | 460 |
Item 2A, paragraph (e) | 850 | 900 |
Item 2A, paragraph (f) | 260 | 280 |
Item 3, paragraph (a) | 260 | 280 |
Item 3, paragraph (b) | 430 | 460 |
Item 3AA | 290 | 310 |
Item 4, subparagraph (a) (i) | 5 760 | 6 120 |
Item 4, subparagraph (a) (ii) |
17 590 | 18 700 |
Item 4, subparagraph (a) (iii) | 42 110 | 44 770 |
Item 4, subparagraph (a) (iv) | 77 290 | 82 170 |
Item 4, subparagraph (a) (v) | 88 480 | 94 070 |
Item 4, subparagraph (a) (vi) | 94 340 | 100 300 |
Item 4, subparagraph (a) (vii) | 99 670 | 105 960 |
Item 4, subparagraph (b) (i) | 3 330 | 3 540 |
Item 4, subparagraph (b) (ii) |
11 350 | 12 070 |
Item 4, subparagraph (b) (iii) | 41 040 | 43 630 |
Item 4, subparagraph (b) (iv) | 60 760 | 64 600 |
Item 4, subparagraph (b) (v) | 66 630 | 70 840 |
Item 4, subparagraph (b) (vi) | 71 960 | 76 500 |
Item 4, subparagraph (c) (i) | 770 | 820 |
Item 4, subparagraph (c) (ii) | 6 610 |
7 030 |
Item 4, subparagraph (c) (iii) | 14 660 | 15 590 |
Item 4, subparagraph (c) (iv) | 19 720 | 20 970 |
Item 4, subparagraph (c) (v) | 30 910 | 32 860 |
Item 4, subparagraph (c) (vi) | 41 040 | 43 630 |
Item 4, subparagraph (c) (vii) | 50 100 | 53 260 |
Item 5, paragraph (a) |
4 580 | 4 870 |
Item 5, subparagraph (b) (i) | 4 580 |
4 870 |
Item 5, subparagraph (b) (ii) | 5 860 | 6 230 |
Item 5, subparagraph (b) (iii) | 8 000 | 8 510 |
Item 5, subparagraph (b) (iv) | 10 660 | 11 330 |
Item 5, subparagraph (b) (v) | 15 990 | 17 000 |
Item 5, subparagraph (b) (vi) | 21 320 | 22 670 |
Item 5, subparagraph (b) (vii) | 31 980 | 34 000 |
Item 5, paragraph (c) | 1 650 | 1 750 |
Item 5, subparagraph (d) (i) | 1 650 | 1 750 |
Item 5, subparagraph (d) (ii) | 5 860 | 6 230 |
Item 5, subparagraph (d) (iii) | 8 000 | 8 510 |
Item 5, subparagraph (d) (iv) | 10 660 |
11 330 |
Item 5, subparagraph (d) (v) | 15 990 | 17 000 |
Item 5, subparagraph (d) (vi) | 21 320 | 22 670 |
Item 5, subparagraph (d) (vii) | 31 980 | 34 000 |
Item 5A, paragraphs (a), (b), (c), (d) and (e) | 3 200 | 3 400 |
Item 5B | 10 660 |
11 330 |
Item 6, paragraph (a) | 18 760 | 19 950 |
Item 6, paragraphs (b), (c) and (ca) | 12 790 | 13 600 |
Item 6, paragraph (d) | 21 320 | 22 670 |
Items 6AA and 6AB | 180 | 190 |
Item 6AC, paragraph (a) | 12 790 | 13 600 |
Item 6AC, paragraph (b) | 3 200 | 3 400 |
Item 6A | 850 | 900 |
Item 6B | 2 130 |
2 270 |
Item 6C | 4 260 | 4 530 |
Item 7, paragraph (a) |
6 400 | 6 800 |
Item 7, paragraphs (b), (c) and (ca) |
5 330 | 5 670 |
Item 7, paragraph (d) | 21 320 | 22 670 |
Item 7, paragraphs (e) and (f) | 5 330 | 5 670 |
Item 7A, paragraph (a) | 4 580 | 4 870 |
Item 7A, subparagraph (b) (i) |
4 580 | 4 870 |
Item 7A, subparagraph (b) (ii) | 5 860 |
6 230 |
Item 7A, subparagraph (b) (iii) | 8 000 | 8 510 |
Item 7A, subparagraph (b) (iv) | 10 660 | 11 330 |
Item 7A, subparagraph (b) (v) | 15 990 | 17 000 |
Item 7A, subparagraph (b) (vi) | 21 320 | 22 670 |
Item 7A, subparagraph (b) (vii) | 31 980 | 34 000 |
Item 7B, paragraph (a) |
4 580 | 4 870 |
Item 7B, subparagraph (b) (i) | 4 580 |
4 870 |
Item 7B, subparagraph (b) (ii) | 5 860 | 6 230 |
Item 7B, subparagraph (b) (iii) | 8 000 | 8 510 |
Item 7B, subparagraph (b) (iv) | 10 660 | 11 330 |
Item 7B, subparagraph (b) (v) | 15 990 | 17 000 |
Item 7B, subparagraph (b) (vi) | 21 320 | 22 670 |
Item 7B, subparagraph (b) (vii) | 31 980 | 34 000 |
Item 8 | 580 | 620 |
Item 9, paragraph (a) | 380 | 400 |
Item 9, paragraph (b) | 790 | 840 |
Item 9AB | 530 | 560 |
Item 9AC | 380 | 400 |
Item 9AD, paragraph (a) | 770 | 820 |
Item 9AD, paragraph (b) | 6 610 |
7 030 |
Item 9AD, paragraph (c) | 14 660 | 15 590 |
Item 9AD, paragraph (d) | 19 720 | 20 970 |
Item 9AD, paragraph (e) |
30 910 | 32 860 |
Item 9AD, paragraph (f) | 41 040 |
43 630 |
Item 9AD, paragraph (g) | 50 100 | 53 260 |
Item 9B |
4 260 | 4 530 |
Item 10 | 70 | 150 |
Items 14 and 14A | 210 | 220 |