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
1 Name of Regulations
These Regulations are the Therapeutic Goods (Medical Devices) Amendment Regulations 2009 (No. 1).
2 Commencement
These Regulations commence on 10 July 2009.
3 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
1. All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003. See http://www.frli.gov.au.