Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2025
I, the Honourable Sam Mostyn AC, Governor‑General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following regulations.
Dated 26 June 2025
Sam Mostyn AC
Governor‑General
By Her Excellency’s Command
Mark Butler
Minister for Health and Ageing
1 Name
2 Commencement
3 Authority
4 Schedules
Schedule 1—Amendments
Part 1—Amendments relating to fees
Therapeutic Goods (Medical Devices) Regulations 2002
Therapeutic Goods Regulations 1990
Part 2—Other amendments
Division 1—Main amendments
Therapeutic Goods (Medical Devices) Regulations 2002
Division 2—Application and transitional provisions
Therapeutic Goods (Medical Devices) Regulations 2002
This instrument is the Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2025.
(1) Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.
Commencement information | ||
Column 1 | Column 2 | Column 3 |
Provisions | Commencement | Date/Details |
1. The whole of this instrument | 1 July 2025. | 1 July 2025 |
Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.
(2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.
This instrument is made under the Therapeutic Goods Act 1989.
Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.
1 Subregulation 9.1AA(1)
Omit “$31”, substitute “$32”.
2 Subregulation 9.1AA(2) (method statement, step 2)
Omit “$31”, substitute “$32”.
3 Paragraph 2.1(b) of Schedule 5
Omit “$496”, substitute “$512”.
4 Amendments of listed provisions—Part 1 of Schedule 5
The items of the table in Part 1 of Schedule 5 listed in the following table are amended as set out in the table.
Amendments relating to fees | |||
Item | Provision | Omit | Substitute |
1 | Item 1.1 | 1,483 | 1,530 |
2 | Item 1.1A | 11,065 | 11,419 |
3 | Item 1.2, paragraph (a) | 9,733 | 10,044 |
4 | Item 1.2, paragraph (b) | 9,786 | 10,099 |
5 | Item 1.3, paragraph (a) | 59,511 | 61,415 |
6 | Item 1.3, paragraph (b) | 45,869 | 47,337 |
7 | Item 1.3A, paragraph (a) | 33,623 | 34,699 |
8 | Item 1.3A, paragraph (b) | 71,650 | 73,943 |
9 | Item 1.3A, paragraph (c) | 17,402 | 17,959 |
10 | Item 1.3A, paragraph (d) | 4,222 | 4,357 |
11 | Item 1.3A, paragraph (e) | 46,299 | 47,781 |
12 | Item 1.3A, paragraph (f) | 29,541 | 30,486 |
13 | Item 1.4A | 5,322 | 5,492 |
14 | Items 1.4B and 1.4C | 2,926 | 3,020 |
15 | Item 1.4D | 86,903 | 89,684 |
16 | Items 1.4E and 1.4F | 62,380 | 64,376 |
17 | Item 1.5, paragraph (b) | 1,483 | 1,530 |
18 | Item 1.5, paragraphs (c) and (d) | 1,150 | 1,187 |
19 | Item 1.5, paragraph (e) | 602 | 621 |
20 | Item 1.5, paragraph (f) | 96 | 99 |
21 | Item 1.5, paragraph (g) | 602 | 621 |
22 | Item 1.5, paragraph (h) | 1,150 | 1,187 |
23 | Item 1.5, paragraph (i) | 96 | 99 |
24 | Item 1.5A | 11,641 | 12,014 |
25 | Item 1.6A, paragraphs (a) and (b) | 181 | 187 |
26 | Item 1.6A, paragraph (b) | 57 | 59 |
27 | Item 1.6B, paragraphs (a) and (b) | 181 | 187 |
28 | Item 1.6B, paragraph (b) | 57 | 59 |
29 | Item 1.7 | 21,697 | 22,391 |
30 | Item 1.7A | 5,922 | 6,112 |
31 | Item 1.8, paragraphs (a) and (b) | 429 | 443 |
32 | Item 1.9, paragraph (a) | 33,516 | 34,589 |
33 | Item 1.9, paragraph (b) | 65,850 | 61,842 |
34 | Item 1.9, paragraph (c) | 45,869 | 47,337 |
35 | Item 1.9, paragraph (d) | 32,119 | 33,147 |
36 | Item 1.9, paragraph (e) | 29,326 | 30,264 |
37 | Item 1.9, paragraph (f) | 25,030 | 25,831 |
38 | Item 1.9A, paragraph (a) | 33,623 | 34,699 |
39 | Item 1.9A, paragraph (b) | 71,650 | 67,288 |
40 | Item 1.9A, paragraph (c) | 17,402 | 17,959 |
41 | Item 1.9A, paragraph (d) | 4,222 | 4,357 |
42 | Item 1.9A, paragraph (e) | 46,299 | 47,781 |
43 | Item 1.9A, paragraph (f) | 29,541 | 30,486 |
44 | Item 1.10, paragraph (a) | 20,196 | 20,842 |
45 | Item 1.10, paragraph (b) | 39,746 | 37,326 |
46 | Item 1.10, paragraph (c) | 27,715 | 28,602 |
47 | Item 1.10, paragraph (d) | 17,402 | 17,959 |
48 | Item 1.10, paragraph (e) | 15,254 | 15,742 |
49 | Item 1.10A, paragraph (a) | 20,174 | 20,820 |
50 | Item 1.10A, paragraph (b) | 42,990 | 40,373 |
51 | Item 1.10A, paragraph (c) | 10,442 | 10,776 |
52 | Item 1.10A, paragraph (d) | 2,533 | 2,614 |
53 | Item 1.10A, paragraph (e) | 27,780 | 28,669 |
54 | Item 1.10A, paragraph (f) | 17,725 | 18,292 |
55 | Item 1.12 | 496 | 512 |
56 | Item 1.13 | 4,554 | 4,700 |
57 | Item 1.14, paragraph (a) | 16,752 | 17,288 |
58 | Item 1.14, paragraph (b) | 4,188 | 4,322 |
59 | Item 1.14A, paragraph (a) | 7,734 | 7,981 |
60 | Item 1.14A, paragraphs (b) and (c) | 23,439 | 24,189 |
61 | Item 1.14A, paragraph (d) | 17,402 | 17,959 |
62 | Item 1.14AA | 14,865 | 15,341 |
63 | Item 1.14B | 23,439 | 24,189 |
64 | Item 1.14C | 17,402 | 17,959 |
65 | Item 1.15, paragraphs (a) and (b) | 565 | 583 |
66 | Item 1.15, paragraph (b) | 113 | 117 |
67 | Item 1.17 | 1,209 | 1,248 |
5 Amendments of listed provisions
The provisions listed in the following table are amended as set out in the table.
Amendments relating to fees | |||
Item | Provision | Omit | Substitute |
1 | Paragraph 43AAJ(1)(b) | 118,064 | 121,712 |
2 | Paragraph 43AC(2)(a) | 4,746 | 4,898 |
3 | Paragraph 43AC(2)(b) | 7,967 | 8,222 |
4 | Paragraph 43AC(2)(c) | 10,397 | 10,730 |
5 | Paragraph 43ACA(2)(aa) | 1,244 | 1,284 |
6 | Paragraph 43ACA(2)(ab) | 9,041 | 9,330 |
7 | Paragraph 43ACA(2)(a) | 4,791 | 4,944 |
8 | Paragraph 43ACA(2)(b) | 7,504 | 7,744 |
9 | Paragraph 43ACA(2)(c) | 11,086 | 11,441 |
10 | Paragraph 45(6)(a) | 1,299 | 1,341 |
11 | Paragraph 45(6)(b) | 5,187 | 5,353 |
6 Amendments of listed provisions—Clause 3 of Schedule 9
The items of the table in Clause 3 of Schedule 9 listed in the following table are amended as set out in the table.
Amendments relating to fees | |||
Item | Provision | Omit | Substitute |
1 | Item 1A, paragraphs (a) and (b) | 565 | 583 |
2 | Item 1A, paragraph (b) | 113 | 117 |
3 | Item 1A, paragraph (c) | 3,712 | 3,831 |
4 | Item 1, paragraph (a) | 2,046 | 2,111 |
5 | Item 1, paragraph (b) | 25,426 | 26,240 |
6 | Item 1AAA, paragraph (a) | 562 | 580 |
7 | Item 1AAA, paragraph(b) | 6,940 | 7,162 |
8 | Item 1AA | 14,805 | 15,279 |
9 | Item 1AB | 5,368 | 5,540 |
10 | Item 1ABA | 9,786 | 10,099 |
11 | Item 1AC, paragraph (a) | 56,956 | 58,779 |
12 | Item 1AC, paragraph (b) | 34,016 | 35,105 |
13 | Item 1AD, paragraph (a) | 297,212 | 306,723 |
14 | Item 1AD, paragraph (b) | 196,070 | 202,344 |
15 | Item 1AE | 33,903 | 34,988 |
16 | Item 1AF | 142,955 | 147,530 |
17 | Item 1AG | 20,455 | 21,110 |
18 | Item 1B | 14,805 | 15,279 |
19 | Item 2, paragraph (ba) | 56,844 | 58,663 |
20 | Item 2, paragraph (bb) | 18,872 | 19,476 |
21 | Item 2, paragraph (bc) | 37,857 | 39,068 |
22 | Item 2, paragraph (bca) | 60,234 | 62,161 |
23 | Item 2, paragraph (bcb) | 1,299 | 1,341 |
24 | Item 2, paragraph (bd) | 33,903 | 34,988 |
25 | Item 2, subparagraph (be)(i) | 11,267 | 11,628 |
26 | Item 2, subparagraph (be)(ii) | 7,356 | 7,591 |
27 | Item 2, subparagraph (bf)(i) | 22,715 | 23,442 |
28 | Item 2, subparagraph (bf)(ii) | 14,692 | 15,162 |
29 | Item 2, paragraph (bfa) | 35,823 | 36,969 |
30 | Item 2, paragraph (bg) | 21,923 | 22,625 |
31 | Item 2, paragraph (bh) | 3,582 | 3,697 |
32 | Item 2, paragraph (bi) | 22,150 | 22,859 |
33 | Item 2, paragraphs (bj) and (bk) | 1,299 | 1,341 |
34 | Item 2, paragraph (c) | 5,175 | 5,341 |
35 | Item 2, paragraph (d) | 2,577 | 2,659 |
36 | Item 2, paragraph (d) | 15,031 | 15,512 |
37 | Item 2A, paragraph (a) | 1,989 | 2,053 |
38 | Item 2A, paragraph (b) | 496 | 512 |
39 | Item 2A, paragraph (c) | 1,466 | 1,513 |
40 | Item 2A, paragraph (d) | 1,832 | 1,891 |
41 | Item 2A, paragraphs (e) and (f) | 1,047 | 1,081 |
42 | Item 2A, paragraph (g) | 199 | 205 |
43 | Item 2AC | 1,299 | 1,341 |
44 | Item 2B | 6,486 | 6,694 |
45 | Item 2C | 5,187 | 5,353 |
46 | Item 2CA | 6,486 | 6,694 |
47 | Items 2CB to 2CE (wherever occurring) | 950 | 980 |
48 | Item 3, paragraph (a) | 2,303 | 2,377 |
49 | Item 3, paragraph (b) | 983 | 1,014 |
50 | Item 3AB, paragraphs (a) and (b) | 496 | 512 |
51 | Item 3AB, paragraph (b) | 57 | 59 |
52 | Item 4, paragraph (a) | 227,825 | 235,115 |
53 | Item 4, subparagraphs (aa)(i) and (ii) | 76,055 | 78,489 |
54 | Item 4, subparagraph (aa)(iii) | 151,545 | 156,394 |
55 | Item 4, paragraph (ab) | 240,934 | 248,644 |
56 | Item 4, paragraph (ac) | 5,187 | 5,353 |
57 | Item 4, paragraph (b) | 135,158 | 139,483 |
58 | Item 4, subparagraph (bb)(i) | 45,090 | 46,533 |
59 | Item 4, subparagraph (bb)(i) | 29,269 | 30,206 |
60 | Item 4, subparagraph (bb)(ii) | 45,090 | 46,533 |
61 | Item 4, subparagraph (bb)(ii) | 29,269 | 30,206 |
62 | Item 4, subparagraph (bb)(iii) | 90,067 | 92,949 |
63 | Item 4, subparagraph (bb)(iii) | 58,878 | 60,762 |
64 | Item 4, paragraph (bc) | 5,187 | 5,353 |
65 | Item 4, paragraph (bd) | 143,295 | 147,880 |
66 | Item 4, paragraph (c) | 87,016 | 89,801 |
67 | Item 4, paragraph (d) | 14,239 | 14,695 |
68 | Item 4, paragraph (g) | 88,146 | 90,967 |
69 | Item 4, paragraph (h) | 5,187 | 5,353 |
70 | Item 6AA | 757 | 781 |
71 | Item 6AB | 814 | 840 |
72 | Item 6ABA | 2,894 | 2,987 |
73 | Item 6AC | 1,367 | 1,411 |
74 | Item 6B | 4,350 | 4,489 |
75 | Item 6BA, paragraphs (a) and (b) | 181 | 187 |
76 | Item 6BA, paragraph (b) | 57 | 59 |
77 | Item 6BB, paragraphs (a) and (b) | 181 | 187 |
78 | Item 6BB, paragraph (b) | 57 | 59 |
79 | Item 6C | 9,447 | 9,749 |
80 | Item 6D, paragraph (a) | 12,431 | 12,829 |
81 | Item 6D, paragraph (b) | 16,047 | 16,561 |
82 | Item 6D, paragraph (c) | 21,923 | 22,625 |
83 | Item 6D, paragraph (d) | 29,043 | 29,972 |
84 | Item 6D, paragraph (e) | 43,508 | 44,900 |
85 | Item 6D, paragraph (f) | 57,973 | 59,828 |
86 | Item 6D, paragraph (g) | 87,016 | 89,801 |
87 | Item 7A, paragraph (a) | 12,431 | 12,829 |
88 | Item 7A, subparagraph (b)(i) | 12,431 | 12,829 |
89 | Item 7A, subparagraph (b)(ii) | 16,047 | 16,561 |
90 | Item 7A, subparagraph (b)(iii) | 21,923 | 22,625 |
91 | Item 7A, subparagraph (b)(iv) | 29,043 | 29,972 |
92 | Item 7A, subparagraph (b)(v) | 43,508 | 44,900 |
93 | Item 7A, subparagraph (b)(vi) | 57,973 | 59,828 |
94 | Item 7A, subparagraph (b)(vii) | 87,016 | 89,801 |
95 | Item 7B, paragraph (a) | 12,431 | 12,829 |
96 | Item 7B, subparagraph (b)(i) | 12,431 | 12,829 |
97 | Item 7B, subparagraph (b)(ii) | 16,047 | 16,561 |
98 | Item 7B, subparagraph (b)(iii) | 21,923 | 22,625 |
99 | Item 7B, subparagraph (b)(iv) | 29,043 | 29,972 |
100 | Item 7B, subparagraph (b)(v) | 43,508 | 44,900 |
101 | Item 7B, subparagraph (b)(vi) | 57,973 | 59,828 |
102 | Item 7B, subparagraph (b)(vii) | 87,016 | 89,801 |
103 | Item 7C | 1,231 | 1,270 |
104 | Item 8, paragraph (a) | 927 | 957 |
105 | Item 8, paragraph (b) | 1,209 | 1,248 |
106 | Items 8A to 8C | 927 | 957 |
107 | Item 9, paragraph (a) | 1,153 | 1,190 |
108 | Item 9, paragraph (b) | 1,616 | 1,668 |
109 | Item 9AA | 790 | 815 |
110 | Item 9AB | 1,074 | 1,108 |
111 | Items 9AC and 9ACA | 790 | 815 |
112 | Item 9AD, paragraph (a) | 1,560 | 1,610 |
113 | Item 9AD, paragraph (b) | 13,222 | 13,645 |
114 | Item 9AD, paragraph (c) | 29,833 | 30,788 |
115 | Item 9AD, paragraph (d) | 40,118 | 41,402 |
116 | Item 9AD, paragraph (e) | 62,493 | 64,493 |
117 | Item 9AD, paragraph (f) | 83,287 | 85,952 |
118 | Item 9AD, paragraph (g) | 101,594 | 104,845 |
119 | Item 10 | 204 | 211 |
120 | Item 14, paragraphs (a) and (b) | 429 | 443 |
121 | Item 18 | 2,622 | 2,706 |
7 Amendments of listed provisions—Clause 4 of Schedule 9
The items of the table in Clause 4 of Schedule 9 listed in the following table are amended as set out in the table.
Amendments relating to fees | |||
Item | Provision | Omit | Substitute |
1 | Item 1, paragraphs (a) and (b) | 1,921 | 1,982 |
2 | Item 1, paragraph (c) | 3,086 | 3,185 |
3 | Item 1, paragraph (d) | 4,509 | 4,653 |
4 | Item 1, paragraph (e) | 6,679 | 6,893 |
5 | Item 1, paragraphs (f) to (h) | 1,921 | 1,982 |
6 | Item 1, paragraph (i) | 3,086 | 3,185 |
7 | Item 2, paragraph (a) | 4,746 | 4,898 |
8 | Item 2, paragraph (b) | 6,747 | 6,963 |
9 | Item 2, paragraph (c) | 10,397 | 10,730 |
10 | Item 2, paragraph (d) | 17,290 | 17,843 |
11 | Item 2, paragraph (e) | 25,426 | 26,240 |
12 | Item 2, paragraph (f) | 4,746 | 4,898 |
13 | Item 2, paragraph (g) | 7,967 | 8,222 |
14 | Item 2, paragraph (h) | 10,397 | 10,730 |
15 | Item 3, paragraphs (d) and (e) | 972 | 1,003 |
16 | Item 3, paragraphs (f) to (h) | 1,549 | 1,599 |
17 | Item 4, paragraphs (d) to (f) | 5,266 | 5,435 |
18 | Item 5, paragraph (a) | 1,921 | 1,982 |
19 | Item 5, paragraph (b) | 6,679 | 6,893 |
20 | Item 5, paragraph (c) | 9,899 | 10,216 |
21 | Item 5, paragraph (d) | 13,448 | 13,878 |
22 | Item 7, paragraph (a) | 1,887 | 1,947 |
23 | Item 7, paragraph (b) | 9,674 | 9,984 |
8 Amendments of listed provisions—Clause 5 of Schedule 9
The items of the table in Clause 5 of Schedule 9 listed in the following table are amended as set out in the table.
Amendments relating to fees | |||
Item | Provision | Omit | Substitute |
1 | Item 1A | 2,316 | 2,390 |
2 | Item 1B | 10,115 | 10,439 |
3 | Item 1C | 927 | 957 |
4 | Items 1D and 1E | 1,074 | 1,108 |
5 | Item 1F | 927 | 957 |
6 | Item 1G | 1,244 | 1,284 |
7 | Item 1H | 9,041 | 9,330 |
8 | Item 1 | 1,685 | 1,739 |
9 | Item 2 | 5,684 | 5,866 |
10 | Item 3 | 8,442 | 8,712 |
11 | Item 4 | 11,980 | 12,363 |
12 | Item 5 | 1,685 | 1,739 |
13 | Item 6 | 882 | 910 |
14 | Item 7 | 4,791 | 4,944 |
15 | Item 8 | 950 | 980 |
16 | Item 9 | 7,504 | 7,744 |
17 | Item 10 | 972 | 1,003 |
18 | Item 11 | 11,086 | 11,441 |
19 | Item 12 | 644 | 665 |
20 | Item 13 | 3,695 | 3,813 |
21 | Item 14 | 2,316 | 2,390 |
22 | Item 15 | 24,748 | 25,540 |
23 | Item 16 | 2,316 | 2,390 |
24 | Item 17 | 24,748 | 25,540 |
25 | Item 18 | 3,062 | 3,160 |
26 | Item 19 | 33,677 | 34,755 |
27 | Item 20 | 3,356 | 3,463 |
28 | Item 21 | 42,943 | 44,317 |
29 | Item 22 | 520 | 537 |
30 | Item 23 | 1,978 | 2,041 |
31 | Item 24 | 2,136 | 2,204 |
32 | Item 25 | 16,387 | 16,911 |
33 | Item 26 | 2,136 | 2,204 |
34 | Item 27 | 16,387 | 16,911 |
35 | Item 28 | 1,266 | 1,307 |
36 | Item 29 | 17,065 | 17,611 |
37 | Item 30 | 1,266 | 1,307 |
38 | Item 31 | 17,065 | 17,611 |
39 | Item 32 | 3,356 | 3,463 |
40 | Item 33 | 27,800 | 28,690 |
41 | Item 34 | 3,356 | 3,463 |
42 | Item 35 | 27,800 | 28,690 |
9 Amendments of listed provisions—Part 2 of Schedule 9A
The items of the table in Part 2 of Schedule 9A listed in the following table are amended as set out in the table.
Amendments relating to fees | |||
Item | Provision | Omit | Substitute |
1 | Items 1 to 2AA | 1,289 | 1,330 |
2 | Item 2A | 15,388 | 15,880 |
3 | Item 3 | 1,289 | 1,330 |
4 | Item 3A, paragraphs (a) and (b) | 496 | 512 |
5 | Item 3A, paragraph (b) | 57 | 59 |
6 | Item 4, paragraph (a) | 89,655 | 92,524 |
7 | Item 4, paragraph (b) | 85,772 | 88,517 |
8 | Item 5, paragraph (a) | 179,752 | 185,504 |
9 | Item 5, paragraph (b) | 171,659 | 177,152 |
10 | Item 6, paragraph (a) | 290,462 | 299,757 |
11 | Item 6, paragraph (b) | 278,904 | 287,829 |
12 | Item 7 | 27,913 | 28,806 |
13 | Item 8 | 1,289 | 1,330 |
14 | Items 8A and 9 | 7,865 | 8,117 |
15 | Item 10 | 20,680 | 21,342 |
16 | Item 11 | 40,683 | 41,985 |
17 | Item 11A, paragraphs (a) and (b) | 565 | 583 |
18 | Item 11A, paragraph (b) | 113 | 117 |
19 | Item 12 | 25,426 | 26,240 |
20 | Item 13 | 19,324 | 19,942 |
21 | Item 14 | 790 | 815 |
22 | Item 16 | 30,964 | 31,955 |
23 | Item 16AA | $8,448 | 8,718 |
24 | Item 16A, paragraphs (a) and (b) | 181 | 187 |
25 | Item 16A, paragraph (b) | 57 | 59 |
26 | Item 16B, paragraphs (a) and (b) | 181 | 187 |
27 | Item 16B, paragraph (b) | 57 | 59 |
28 | Item 17, paragraphs (a) and (b) | 429 | 443 |
10 Part 2 of Schedule 4 (at the end of the table)
Add:
2.19 | Medical device that is: (a) a Class 4 in‑house IVD medical device; and (b) intended by its manufacturer to be used to detect the presence of, or exposure to, the coronavirus known as severe acute respiratory syndrome coronavirus 2 or SARS‑CoV‑2 for the purpose of assessing the suitability of a person to donate, for transfusion or transplantation, any of the following of human origin: (i) blood, blood components, blood products, cells, tissues or organs; (ii) any other derivatives of the things covered by subparagraph (i) | (a) The device must be manufactured only at, or supplied only from, an accredited pathology laboratory (within the meaning of subsection 3(1) of the Health Insurance Act 1973). (b) The manufacturer or supplier of the device must: (i) keep records relating to the manufacture, supply or both (as applicable) of the device by the manufacturer or supplier; and (ii) if requested by the Secretary, give a copy of the records to the Secretary. (c) If the manufacture of the device commences on or after 1 July 2025, the device must comply with the essential principles. (d) If the manufacture of the device commences on or after 1 July 2025, the manufacturer of the device must apply the appropriate conformity assessment procedures in relation to the device at all times. (e) The manufacturer of the device must, if requested by the Secretary, provide the following information within 20 working days of receiving the request: (i) if the manufacture of the device commences on or after 1 July 2025—whether the device complies with the essential principles; (ii) if the manufacture of the device commences on or after 1 July 2025—whether the conformity assessment procedures have been applied to the device; (iii) whether the device complies with every applicable requirement (if any) relating to advertising under Part 5‑1 of the Act or the Therapeutic Goods Regulations 1990. (f) The manufacturer of the device must, at all times, have available: (i) if the manufacture of the device commences on or after 1 July 2025—sufficient information to substantiate that the conformity assessment procedures have been applied to the device; and (ii) information relating to any changes to the device and quality management system. (g) The manufacturer or supplier must allow an authorised person to do any of the following: (i) enter, at any reasonable time, any premises at which the device is manufactured or from which the device is supplied (as applicable); (ii) inspect the premises and the device, and examine, take measurements of, conduct tests on or require tests to be conducted on the device or anything on those premises that relates to the device; (iii) make any still or moving image or any recording of those premises or anything on those premises. (h) If asked to do so by an authorised person, the manufacturer or supplier must produce to the person any documents relating to the device that the person requires and allow the person to copy the documents. (i) The Secretary must not have directed that the supply of the device be stopped or should cease because the supply compromises public health and safety. |
11 In the appropriate position in Part 11
Insert:
The amendment of Schedule 4 to these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2025 applies in relation to therapeutic goods on and after 1 July 2025 regardless of whether the goods were manufactured before, on or after that day.