Therapeutic Goods (Medical Devices) Amendment Regulations 2009 (No. 1) (Cth)

Therapeutic Goods (Medical Devices) Amendment Regulations 2009 (No. 1)¹

Select Legislative Instrument 2009 No. 181

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 9 July 2009

QUENTIN BRYCE

Governor-General

By Her Excellency’s Command

MARK BUTLER

Parliamentary Secretary for Health

Name of Regulations

These Regulations are the Therapeutic Goods (Medical Devices) Amendment Regulations 2009 (No. 1).

Commencement

These Regulations commence on 10 July 2009.

Amendment of Therapeutic Goods (Medical Devices) Regulations 2002

Schedule 1 amends the Therapeutic Goods (Medical Devices) Regulations 2002.

Schedule 1 Amendments

(regulation 3)

[1] Paragraph 9.4 (2) (b)

omit

$3 010

insert

$3 140

[2] Schedule 5, Part 1, items 1.1, 1.2 and 1.3

substitute

1.1	Application for conformity assessment certificate	Paragraph 41EB (2) (a) of the Act	770
1.2	Review of conformity assessment certificate — surveillance assessment for conformity assessment certificate issued under conformity assessment procedures set out in Schedule 3, Part 1, 4 or 5 Note 1 If the assessment involves an assessment of a medicinal component, an additional fee is payable — see item 1.11. Note 2 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.	Subsection 41EJ (4) of the Act	6 760
1.3	Review of conformity assessment certificate — in relation to certification of compliance with the essential principles for conformity assessment certificate issued under conformity assessment procedures set out in:	Subsection 41EJ (4) of the Act
(a) Schedule 3, clause 1.6; or	41 500
(b) Schedule 3, Part 2 (including management of testing, analysis, and reporting on examination of the type)	31 900
Note 1 If the assessment involves an assessment of a medicinal component, an additional fee is payable — see item 1.11. Note 2 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 3 For an assessment under paragraph (b), an additional fee to cover the costs of testing the relevant kind of medical device is also payable — see clause 2.2 of this Schedule.

[3] Schedule 5, Part 1, item 1.5

substitute

1.5	Application for the following kinds of medical devices to be included in the Register:	Paragraph 41FC (2) (b) of the Act
(a) a Class AIMD medical device;	1 030
(b) a Class III medical device	1 030
(c) a Class IIb medical device;	790
(d) a Class IIa medical device;	790
(e) a Class I medical device that the manufacturer intends to be supplied in a sterile state or that has a measuring function Note for paragraph (e) There is no fee for an application to include any other Class I medical device in the Register.	790

[4] Schedule 5, Part 1, items 1.7, 1.8, 1.9 and 1.10

substitute

1.7	Application for approval to use a specified kind of medical device solely for experimental purposes in humans	Paragraph 41HB (5) (c) of the Act	14 300
1.8	Notification of intention to sponsor a clinical trial of a medical device to be used solely for experimental purposes in humans	Schedule 4, item 2.3, paragraph (b) of these Regulations	270
1.9	Conformity assessment — initial assessment under conformity assessment procedures set out in:	Subsections 41LA (1) and (2) of the Act
(a) Schedule 3, Part 1; or	23 200
(b) Schedule 3, clause 1.6; or	45 800
(c) Schedule 3, Part 2 (including management of testing, analysis, and reporting on examination of the type); or	31 900
(d) Schedule 3, Part 3 (including management of testing, analysis, and reporting on verification of the type); or	22 300
(e) Schedule 3, Part 4; or	20 300
(f) Schedule 3, Part 5 Note 1 If the assessment involves an assessment of a medicinal component, an additional fee is payable — see item 1.11.	17 400
Note 2 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 3 For an assessment under paragraph (c) or (d), an additional fee to cover the costs of testing the relevant kind of medical device is also payable — see clause 2.2 of this Schedule. Note 4 If the assessment is abridged, a reduced fee is payable — see regulation 9.4.
1.10	Conformity assessment — assessment consequent on change to medical device, or quality management system applying to medical device, under conformity assessment procedures set out in:	Subsections 41LA (1) and (2) of the Act
(a) Schedule 3, Part 1; or	14 000
(b) Schedule 3, clause 1.6; or	27 500
(c) Schedule 3, Part 2 (including management of testing, analysis, and reporting on examination of the type); or	19 200
(d) Schedule 3, Part 4; or	12 200
(e) Schedule 3, Part 5 Note 1 If the assessment involves an assessment of a medicinal component, an additional fee is payable — see item 1.11.	10 500
Note 2 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 3 For an assessment under paragraph (c), 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.

[5] Schedule 5, Part 1, items 1.12, 1.13, 1.14 and 1.15

substitute

1.12	If a supplementary assessment of a medical device is required, in addition to the assessment mentioned in item 1.2, 1.3, 1.9 or 1.10 Note For an assessment conducted outside Australia, an additional fee is payable — see clause 2.1 of this Schedule.	Subsections 41EJ (4) and 41LA (1) and (2) of the Act	320 for each hour for each assessor involved
1.13	Application audit assessment, Level 1 — verification of sponsor’s application and evidence of conformity	Subsections 41LA (3) and (4) of the Act	3 010
1.14	Application audit assessment, Level 2 — for Level 1 activities and review of evidence of conformity	Subsections 41LA (3) and (4) of the Act	5 520
1.15	Application for consent of Secretary to importation into Australia, supply for use in Australia, or exportation from Australia of medical device	Section 41MA and paragraph 63 (2) (h) of the Act	350

[6] Schedule 5, Part 2, paragraph 2.1 (b)

omit

$310

insert

$320

Note

All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003. See