Therapeutic Goods (Medical Devices) Amendment Regulations 2006 (No. 1) (Cth)

Therapeutic Goods (Medical Devices) Amendment Regulations 2006 (No. 1)¹

Select Legislative Instrument 2006 No. 214

I, PHILIP MICHAEL JEFFERY, 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 10 August 2006

P. M. JEFFERY

Governor‑General

By His Excellency’s Command

CHRISTOPHER PYNE

Parliamentary Secretary to the Minister for Health and Ageing

Name of Regulations

These Regulations are the Therapeutic Goods (Medical Devices) Amendment Regulations 2006 (No. 1).

Commencement

These Regulations commence on the day after they are registered.

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

$2 710

insert

$2 800

[2] Schedule 5, Part 1

substitute

Part 1 General

Item	Matter	Provision of Act or these Regulations	Amount ($)
1.1	Application for conformity assessment certificate	Paragraph 41EB (2) (a) of the Act	680
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	6 010
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	36 900
(b) Schedule 3, Part 2 (including management of testing, analysis, and reporting on examination of the type)	28 400
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.
1.4	Considering a submission to the Secretary in relation to a proposed suspension of a conformity assessment certificate	Subsection 41EN (2) and paragraph 63 (2) (h) of the Act	The fee applicable under item 1.14 to the kind of work to be undertaken
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;	920
(b) a Class III medical device	920
(c) a Class Iib medical device;	700
(d) a Class Iia medical device;	700
(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.	700
1.6	Considering submissions to the Secretary in relation to a proposed suspension of a kind of medical device from the Register	Subsection 41GB (2) and paragraph 63 (2) (h) of the Act	The fee applicable under item 1.14 to the kind of work to be undertaken
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	12 700
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	20 600
(b) Schedule 3, clause 1.6; or	40 800
(c) Schedule 3, Part 2 (including management of testing, analysis, and reporting on examination of the type); or	28 400
(d) Schedule 3, Part 3 (including management of testing, analysis, and reporting on verification of the type); or	19 900
(e) Schedule 3, Part 4; or	18 100
(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. 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.	15 500
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	12 400
(b) Schedule 3, clause 1.6; or	24 500
(c) Schedule 3, Part 2 (including management of testing, analysis, and reporting on examination of the type); or	17 100
(d) Schedule 3, Part 4; or	10 900
(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.	9 340
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.
1.11	If an assessment of a medical device involves an assessment of the medicinal component of the device — for an assessment of the data relating to the medicinal component (and in addition to the fee required under item 1.2, 1.3, 1.9 or 1.10)	Subsections 41EJ (4) and 41LA (1) and (2) of the Act	The fee applicable under item 4, or paragraph (b) or (d) of item 5, of Part 2 of Schedule 9 to the Therapeutic Goods Regulations 1990
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	290 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	2 680
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	4 910
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	320
1.16	Intermediate stage assessment or verification procedures to be carried out in relation to the application of the conformity assessment procedures to an article	Subregulation 3.13 (1) of these Regulations	The fee applicable under item 1.9, 1.10 or 1.12 to the kind of work to be undertaken

Note

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