Federal Register of Legislation - Australian Government

Primary content

Regulations as made
This instrument amends the Therapeutic Goods (Medical Devices) Regulations 2002 and the Therapeutic Goods Regulations 1990, to increase most fees set out in those respective regulations by 5.2 per cent for the 2023-24 financial year, and implement a number of other measures.
Administered by: Health and Aged Care
Registered 13 Jun 2023
Tabling HistoryDate
Tabled HR14-Jun-2023
Tabled Senate15-Jun-2023
Date of repeal 06 Sep 2023
Repealed by Division 1 of Part 3 of Chapter 3 of the Legislation Act 2003
Table of contents.

Commonwealth Coat of Arms of Australia

 

Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2023

I, General the Honourable David Hurley AC DSC (Retd), Governor‑General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following regulations.

Dated                           8 June  2023

David Hurley

Governor‑General

By His Excellency’s Command

Mark Butler

Minister for Health and Aged Care

 

 

 

  

  


Contents

1............ Name............................................................................................................................. 1

2............ Commencement............................................................................................................. 1

3............ Authority....................................................................................................................... 1

4............ Schedules...................................................................................................................... 1

Schedule 1—Amendments                                                                                                                          2

Therapeutic Goods (Medical Devices) Regulations 2002                                                             2

Therapeutic Goods Regulations 1990                                                                                               6

 


1  Name

                   This instrument is the Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2023.

2  Commencement

             (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 2023.

1 July 2023

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.

3  Authority

                   This instrument is made under the Therapeutic Goods Act 1989.

4  Schedules

                   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 1Amendments

  

Therapeutic Goods (Medical Devices) Regulations 2002

1  After Part 8

Insert:

Part 8AWaiver and refund of charges

  

8A.1  Definitions

                   In this Part:

charge year has the same meaning as in the Therapeutic Goods (Charges) Regulations 2018.

transitional medical device means a medical device of a kind mentioned in column 1 of an item in the following table if:

                     (a)  the medical device was, immediately before 25 November 2021, included in the Register and classified as a class of medical device mentioned in column 2 of the item; or

                     (b)  on 25 November 2021:

                              (i)  the medical device was the subject of a class of application mentioned in column 2 of the item for inclusion in the Register; and

                             (ii)  the application had not been finally determined.

 

Transitional medical device

Column 1

Column 2

Item

Kind of medical device

Class of medical device or application

1

a medical device of a kind described in subclause 3.4(4B) of Schedule 2

Class IIb

2

a medical device of a kind described in clause 5.10 of Schedule 2

Class I or Class IIa

3

a medical device of a kind described in clause 5.11 of Schedule 2

Class I, Class IIa or Class IIb

4

a medical device of a kind described in subclause 4.2(4) of Schedule 2

Class IIa or Class IIb

5

a medical device of a kind described in subclause 3.2(3A) of Schedule 2

Class IIa or Class IIb

8A.2  Waiver of charges in relation to transitional medical devices

             (1)  This subregulation applies in relation to a kind of medical device if, at any time during a charge year:

                     (a)  the medical device is a transitional medical device; and

                     (b)  the entry for the kind of medical device in the Register does not include any medical device that is not a transitional medical device; and

                     (c)  the medical device is included in the Register and classified both as:

                              (i)  a class of medical device mentioned in column 2 of an item of the table in the definition of transitional medical device in regulation 8A.1; and

                             (ii)  a class of medical device described in the provision mentioned in column 1 of that item; and

                     (d)  the same kind of medical device is also listed in the Private Health Insurance (Medical Devices and Human Tissue Products) Rules, made under the Private Health Insurance Act 2007, as in force from time to time.

             (2)  The Secretary must, on behalf of the Commonwealth, waive the annual charge payable under the Therapeutic Goods (Charges) Act 1989 in respect of the inclusion of the kind of transitional medical device in the Register during the charge year if:

                     (a)  the person liable to pay the charge applies for the charge to be waived for the charge year; and

                     (b)  the application is made in the form (if any) approved, in writing, by the Secretary for the purposes of this subregulation; and

                     (c)  the Secretary is reasonably satisfied that subregulation (1) applies in relation to the transitional medical device.

8A.3  Refund of certain charges in relation to transitional medical devices

             (1)  This subregulation applies in relation to a kind of medical device if, at any time during a charge year:

                     (a)  the medical device is a transitional medical device; and

                     (b)  the entry for the kind of medical device in the Register does not include any medical device that is not a transitional medical device; and

                     (c)  the medical device is included in the Register and classified both as:

                              (i)  a class of medical device mentioned in column 2 of an item of the table in the definition of transitional medical device in regulation 8A.1; and

                             (ii)  a class of medical device described in the provision mentioned in column 1 of that item; and

                     (d)  the same kind of medical device is also listed in the Private Health Insurance (Medical Devices and Human Tissue Products) Rules, made under the Private Health Insurance Act 2007, as in force from time to time; and

                     (e)  the annual charge payable under the Therapeutic Goods (Charges) Act 1989 in respect of the inclusion of the kind of medical device in the Register during the charge year has been paid.

             (2)  The Secretary must, on behalf of the Commonwealth, refund an amount equal to the charge paid if:

                     (a)  the person who paid the charge applies for the charge to be refunded; and

                     (b)  the application is made in the form (if any) approved, in writing, by the Secretary for the purposes of this subregulation; and

                     (c)  the Secretary is reasonably satisfied that subregulation (1) applies in relation to the transitional medical device.

2  Before paragraph 10.7(1A)(a)

Insert:

                    (aa)  a decision to refuse to agree to an application under subregulation 8A.2(2) or 8A.3(2) for a waiver or refund of annual charge;

3  Part 1 of Schedule 5 (table item 1.10A)

Repeal the item, substitute:

1.10A

Conformity assessment—assessment because of changes or proposed changes to an IVD medical device or quality management system applying to that device, under conformity assessment procedures set out in:

Subsections 41LA(1) and (2) of the Act

 

 

(a) Schedule 3, Part 1—Full Quality Management System; or

 

19,268

 

(b) Schedule 3, clause 1.6—Design Examination; or

 

41,060

 

(c) Schedule 3, clause 1.6—Design Examination – Immunohaematology reagent medical devices; or

 

9,973

 

(d) Schedule 3, clause 1.6—Abridged Design Examination – previously registered IVDs; or

 

2,419

 

(e) Schedule 3, Part 2—Type Examination; or

 

26,533

 

(f) Schedule 3, Part 4—Production Quality Management System

 

16,929

 

Note 1:    If a supplementary assessment, or an assessment outside Australia, is required, an additional fee is payable—see item 1.12 and clause 2.1 of this Schedule.

 

 

 

Note 2:    For an assessment under Schedule 3, Part 2, an additional fee to cover the costs of testing the relevant kind of medical device, or quality management system, is also payable—see clause 2.2 of this Schedule.

 

 

4  Part 1 of Schedule 5 (table items 1.14, 1.14A and 1.14B)

Repeal the items, substitute:

1.14

Application audit assessment, Level 2—for Level 1 activities and review of evidence of conformity for the following kinds of medical device:

Subsections 41LA(3) and (4) of the Act

 

 

(a) Class III medical devices (other than IVD medical devices);

 

16,000

 

(b) all other medical devices (other than IVD medical devices)

 

4,000

1.14A

Application audit assessment for the following kinds of medical devices:

Subsections 41LA(3) and (4) of the Act

 

 

(a) Class 1 and Class 2 IVD medical devices;

 

7,387

 

(b) Class 3 IVD medical devices;

 

22,387

 

(c) Class 4 IVD medical devices, other than:

(i) Class 4 IVD medical devices that are immunohaematology reagent IVD medical devices; or

(ii) devices to which item 1.14B or 1.14C applies;

 

22,387

 

(d) Class 4 IVD medical devices that are immunohaematology reagent IVD medical devices

 

16,621

1.14B

Application audit assessment for Class 4 in‑house IVD medical devices (other than a device to which item 1.14C applies)

Subsections 41LA(3) and (4) of the Act

22,387

5  Paragraph 2.1(b) of Part 2 of Schedule 5

Omit “$451”, substitute “$474”.

6  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

1,077

1,416

2

Item 1.4A

4,832

5,083

3

Items 1.4B and 1.4C

2,657

2,795

4

Item 1.4D

78,899

83,002

5

Items 1.4E and 1.4F

56,635

59,580

6

Item 1.5, paragraph (e)

1,098

575

7

Item 1.5A

10,568

11,118

8

Item 1.6A, paragraphs (a) and (b)

164

173

9

Item 1.6A, paragraph (b)

51

54

10

Item 1.6B, paragraphs (a) and (b)

164

173

11

Item 1.6B, paragraph (b)

51

54

12

Item 1.7

19,699

20,723

13

Item 1.7A

5,376

5,656

14

Item 1.8

390

410

14A

Item 1.12

451

474

15

Item 1.13

4,135

4,350

16

Item 1.15, paragraphs (a) and (b)

513

540

17

Item 1.15, paragraph (b)

103

108

18

Item 1.17

1,098

1,155

Therapeutic Goods Regulations 1990

7  Part 2 of Schedule 9 (table items 2A and 2AB)

Repeal the items, substitute:

2A

Fee for varying an entry in the Register (not including evaluation of data) under section 9D (other than subsection 9D(2C)) of the Act, if the variation is for:

 

 

(a) a registered medicine that is mentioned in Part 1 of Schedule 10—for each submission

1,900

 

(b) a listed medicine

474

 

(c) a disinfectant

1,400

 

(d) a Class 3 or Class 4 IVD medical device that is not covered by paragraph (g)

1,750

 

(e) an IVD medical device that is not:

(i) a Class 3 or Class 4 IVD medical device; and

(ii) covered by paragraph (g)

1,000

 

(f) a medical device that is not:

(i) an IVD medical device; and

(ii) covered by paragraph (g)

1,000

 

(g) a medical device, if the following are satisfied:

(i) the reason for the variation is that the kind of medical device is affected by the EU transition (within the meaning of subregulation 9.1AA(3) of the Therapeutic Goods (Medical Devices) Regulations 2002);

(ii) the variation only relates to an update to the manufacturer’s evidence for the medical device recorded in the entry in the Register for that kind of medical device;

(iii) the request is to vary one or more entries in the Register and the manufacturer’s evidence to which the update relates is the same for each of the entries

190 per 10 entries (or part thereof)

8  Part 2 of Schedule 9 (table item 9B)

Repeal the item.

9  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)

105,575

111,065

2

Paragraph 43AC(2)(a)

4,309

4,533

3

Paragraph 43AC(2)(b)

7,233

7,609

4

Paragraph 43AC(2)(c)

9,439

9,930

5

Paragraph 43ACA(2)(aa)

1,129

1,188

6

Paragraph 43ACA(2)(ab)

8,208

8,635

7

Paragraph 43ACA(2)(a)

4,350

4,576

8

Paragraph 43ACA(2)(b)

6,813

7,167

9

Paragraph 43ACA(2)(c)

10,065

10,588

10

Paragraph 45(6)(a)

1,180

1,241

11

Paragraph 45(6)(b)

4,709

4,954

10  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)

513

540

2

Item 1A, paragraph (b)

103

108

3

Item 1, paragraph (a)

1,857

1,954

4

Item 1, paragraph (b)

23,085

24,285

5

Item 1AAA, paragraph (a)

510

537

6

Item 1AAA, paragraph (b)

6,300

6,628

7

Item 1AA

13,441

14,140

8

Item 1AB

4,874

5,127

9

Item 1ABA

8,885

9,347

10

Item 1AC, paragraph (a)

51,710

54,399

11

Item 1AC, paragraph (b)

30,883

32,489

12

Item 1AD, paragraph (a)

269,838

283,870

13

Item 1AD, paragraph (b)

178,011

187,268

14

Item 1AE

30,780

32,381

15

Item 1AF

129,789

136,538

16

Item 1AG

18,571

19,537

17

Item 1B

13,441

14,140

18

Item 2, paragraph (ba)

51,608

54,292

19

Item 2, paragraph (bb)

17,134

18,025

20

Item 2, paragraph (bc)

34,371

36,158

21

Item 2, paragraph (bca)

54,686

57,530

22

Item 2, paragraph (bd)

30,780

32,381

23

Item 2, subparagraph (be)(i)

10,229

10,761

24

Item 2, subparagraph (be)(ii)

6,679

7,026

25

Item 2, subparagraph (bf)(i)

20,623

21,695

26

Item 2, subparagraph (bf)(ii)

13,338

14,032

27

Item 2, paragraph (bfa)

32,524

34,215

28

Item 2, paragraph (bg)

19,904

20,939

29

Item 2, paragraph (bh)

3,252

3,421

30

Item 2, paragraph (bi)

20,110

21,156

31

Item 2, paragraphs (bj) and (bk)

1,180

1,241

32

Item 2, paragraph (c)

4,699

4,943

33

Item 2, paragraph (d)

2,339

2,461

34

Item 2, paragraph (d)

13,646

14,356

35

Item 2AC

1,180

1,241

36

Item 2B

5,889

6,195

37

Item 2C

4,709

4,954

38

Item 2CA

5,889

6,195

39

Items 2CB to 2CE (wherever occurring)

862

907

40

Item 3, paragraph (a)

482

2,200

41

Item 3, paragraph (b)

893

939

42

Item 3AB, paragraphs (a) and (b)

451

474

43

Item 3AB, paragraph (b)

51

54

44

Item 4, paragraph (a)

206,842

217,598

45

Item 4, subparagraphs (aa)(i) and (ii)

69,050

72,641

46

Item 4, subparagraph (aa)(iii)

137,587

144,742

47

Item 4, paragraph (ab)

218,743

230,118

48

Item 4, paragraph (b)

122,710

129,091

49

Item 4, subparagraph (bb)(i)

40,937

43,066

50

Item 4, subparagraph (bb)(i)

26,573

27,955

51

Item 4, subparagraph (bb)(ii)

40,937

43,066

52

Item 4, subparagraph (bb)(ii)

26,573

27,955

53

Item 4, subparagraph (bb)(iii)

81,772

86,024

54

Item 4, subparagraph (bb)(iii)

53,455

56,235

55

Item 4, paragraph (bc)

4,709

4,954

56

Item 4, paragraph (bd)

130,097

136,862

57

Item 4, paragraph (c)

79,002

83,110

58

Item 4, paragraph (d)

12,928

13,600

59

Item 4, paragraph (g)

80,028

84,189

60

Item 4, paragraph (h)

4,709

4,954

61

Item 6AA

687

723

62

Item 6AB

739

777

63

Item 6ABA

2,627

2,764

64

Item 6AC

1,241

1,306

65

Item 6B

3,950

4,155

66

Item 6BA, paragraphs (a) and (b)

164

173

67

Item 6BA, paragraph (b)

51

54

68

Item 6BB, paragraphs (a) and (b)

164

173

69

Item 6BB, paragraph (b)

51

54

70

Item 6C

8,577

9,023

71

Item 6D, paragraph (a)

11,286

11,873

72

Item 6D, paragraph (b)

14,569

15,327

73

Item 6D, paragraph (c)

19,904

20,939

74

Item 6D, paragraph (d)

26,368

27,739

75

Item 6D, paragraph (e)

39,501

41,555

76

Item 6D, paragraph (f)

52,634

55,371

77

Item 6D, paragraph (g)

79,002

83,110

78

Item 7A, paragraph (a)

11,286

11,873

79

Item 7A, subparagraph (b)(i)

11,286

11,873

80

Item 7A, subparagraph (b)(ii)

14,569

15,327

81

Item 7A, subparagraph (b)(iii)

19,904

20,939

82

Item 7A, subparagraph (b)(iv)

26,368

27,739

83

Item 7A, subparagraph (b)(v)

39,501

41,555

84

Item 7A, subparagraph (b)(vi)

52,634

55,371

85

Item 7A, subparagraph (b)(vii)

79,002

83,110

86

Item 7B, paragraph (a)

11,286

11,873

87

Item 7B, subparagraph (b)(i)

11,286

11,873

88

Item 7B, subparagraph (b)(ii)

14,569

15,327

89

Item 7B, subparagraph (b)(iii)

19,904

20,939

90

Item 7B, subparagraph (b)(iv)

26,368

27,739

91

Item 7B, subparagraph (b)(v)

39,501

41,555

92

Item 7B, subparagraph (b)(vi)

52,634

55,371

93

Item 7B, subparagraph (b)(vii)

79,002

83,110

94

Item 7C

1,118

1,176

95

Item 8, paragraph (a)

841

885

96

Item 8, paragraph (b)

1,098

1,155

97

Items 8A to 8C

841

855

98

Item 9, paragraph (a)

1,047

1,101

99

Item 9, paragraph (b)

1,467

1,543

100

Item 9AA

718

755

101

Item 9AB

975

1,026

102

Items 9AC and 9ACA

718

755

103

Item 9AD, paragraph (a)

1,416

1,490

104

Item 9AD, paragraph (b)

12,004

12,628

105

Item 9AD, paragraph (c)

27,086

28,494

106

Item 9AD, paragraph (d)

36,423

38,317

107

Item 9AD, paragraph (e)

56,738

59,688

108

Item 9AD, paragraph (f)

75,616

79,548

109

Item 9AD, paragraph (g)

92,237

97,033

110

Item 10

185

195

111

Item 14, paragraphs (a) and (b)

390

410

112

Item 18

2,380

2,504

11  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)

1,744

1,835

2

Item 1, paragraph (c)

2,801

2,947

3

Item 1, paragraph (d)

4,094

4,307

4

Item 1, paragraph (e)

6,064

6,379

5

Item 1, paragraphs (f) to (h)

1,744

1,835

6

Item 1, paragraph (i)

2,801

2,947

7

Item 2, paragraph (a)

4,309

4,533

8

Item 2, paragraph (b)

6,125

6,444

9

Item 2, paragraph (c)

9,439

9,930

10

Item 2, paragraph (d)

15,698

16,514

11

Item 2, paragraph (e)

23,085

24,285

12

Item 2, paragraph (f)

4,309

4,533

13

Item 2, paragraph (g)

7,233

7,609

14

Item 2, paragraph (h)

9,439

9,930

15

Item 3, paragraphs (d) and (e)

882

928

16

Item 3, paragraphs (f) to (h)

1,406

1,479

17

Item 4, paragraphs (d) to (f)

4,781

5,030

18

Item 5, paragraph (a)

1,744

1,835

19

Item 5, paragraph (b)

6,064

6,379

20

Item 5, paragraph (c)

8,988

9,455

21

Item 5, paragraph (d)

12,209

12,844

22

Item 7, paragraph (a)

1,713

1,802

23

Item 7, paragraph (b)

8,783

9,240

12  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

2,103

2,212

2

Item 1B

9,183

9,661

3

Item 1C

841

885

4

Items 1D and 1E

975

1,026

5

Item 1F

841

885

6

Item 1G

1,129

1,188

7

Item 1H

8,208

8,635

8

Item 1

1,529

1,609

9

Item 2

5,161

5,429

10

Item 3

7,664

8,063

11

Item 4

10,876

11,442

12

Item 5

1,529

1,609

13

Item 6

800

842

14

Item 7

4,350

4,576

15

Item 8

862

907

16

Item 9

6,813

7,167

17

Item 10

882

928

18

Item 11

10,065

10,588

19

Item 12

585

615

20

Item 13

3,355

3,529

21

Item 14

2,103

2,212

22

Item 15

22,469

23,637

23

Item 16

2,103

2,212

24

Item 17

22,469

23,637

25

Item 18

2,780

2,925

26

Item 19

30,575

32,165

27

Item 20

3,047

3,205

28

Item 21

38,988

41,015

29

Item 22

472

497

30

Item 23

1,796

1,889

31

Item 24

1,939

2,040

32

Item 25

14,877

15,651

33

Item 26

1,939

2,040

34

Item 27

14,877

15,651

35

Item 28

1,149

1,209

36

Item 29

15,493

16,299

37

Item 30

1,149

1,209

38

Item 31

15,493

16,299

39

Item 32

3,047

3,205

40

Item 33

25,240

26,552

41

Item 34

3,047

3,205

42

Item 35

25,240

26,552

13  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 and 2

1,170

1,231

2

Item 2A

13,971

14,697

3

Item 3

1,170

1,231

4

Item 3A, paragraphs (a) and (b)

451

474

5

Item 3A, paragraph (b)

51

54

6

Item 4, paragraph (a)

81,397

85,630

7

Item 4, paragraph (b)

77,873

81,922

8

Item 5, paragraph (a)

163,197

171,683

9

Item 5, paragraph (b)

155,849

163,953

10

Item 6, paragraph (a)

263,710

277,423

11

Item 6, paragraph (b)

253,217

266,384

12

Item 7

25,342

26,660

13

Item 8

1,170

1,231

14

Items 8A and 9

7,141

7,512

15

Item 10

18,776

19,752

16

Item 11

36,936

38,857

17

Item 11A, paragraphs (a) and (b)

513

540

18

Item 11A, paragraph (b)

103

108

19

Item 12

23,085

24,285

20

Item 13

17,545

18,457

21

Item 14

718

755

22

Item 16

28,112

29,574

23

Item 16AA

7,670

8,069

24

Item 16A, paragraphs (a) and (b)

164

173

25

Item 16A, paragraph (b)

51

54

26

Item 16B, paragraphs (a) and (b)

164

173

27

Item 16B, paragraph (b)

51

54

28

Item 17, paragraphs (a) and (b)

390

410