Federal Register of Legislation - Australian Government

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SR 2003 No. 153 Regulations as made
These Regulations amend the Therapeutic Goods (Medical Devices) Regulations 2002.
Administered by: Health
General Comments: This instrument was backcaptured in accordance with Section 36 of the Legislative Instruments Act 2003
Registered 01 Jan 2005
Tabling HistoryDate
Tabled HR11-Aug-2003
Tabled Senate11-Aug-2003
Gazetted 26 Jun 2003
Date of repeal 19 Mar 2014
Repealed by Health (Spent and Redundant Instruments) Repeal Regulation 2014

Therapeutic Goods (Medical Devices) Amendment Regulations 2003 (No. 1)1

Statutory Rules 2003 No. 1532

I, GUY STEPHEN MONTAGUE GREEN, Administrator 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 25 June 2003

G. S. M. GREEN

Administrator

By His Excellency’s Command

TRISH WORTH


1              Name of Regulations

                These Regulations are the Therapeutic Goods (Medical Devices) Amendment Regulations 2003 (No. 1).

2              Commencement

                These Regulations commence on 1 July 2003.

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

$2 500.

insert

$2 585.

[2]           After regulation 9.5

insert

9.6           Reduction of assessment fees

                The Secretary may reduce by 70% the amount of an assessment fee specified in Schedule 5 in relation to a medical device if the supply of the medical device:

                (a)    is in the interest of public health; and

               (b)    would not be commercially viable for the manufacturer or sponsor of the medical device if the full amount of the fee were paid.

9.7           Reduction of assessment fees — abridged assessment

         (1)   This regulation applies to an assessment fee specified in Part 1 of Schedule 5 in relation to any of the following:

                (a)    items 1.2 and 1.3 (review of conformity assessment certificate);

               (b)    item 1.9 (initial assessment under conformity assessment procedures);

                (c)    item 1.10 (assessment consequent on a change to:

                          (i)    a medical device; or

                         (ii)    the quality management system applying to a medical device);

               (d)    items 1.13 and 1.14 (application subject to audit assessment);

                (e)    item 1.16 (intermediate stage assessment or verification procedures).

         (2)   The Secretary may reduce the amount of the assessment fee if the Secretary has information that allows the assessment to be abridged, being information about:

                (a)    the medical device to which the fee relates; or

               (b)    some or all aspects of whether the conformity assessment procedures have been applied to the medical device.

[3]           Schedule 5, item 1.11, column 4

omit

paragraph 4 (b) or (c) or 5 (b) or (d) of

insert

item 4, or paragraph (b) or (d) of item 5, of Part 2 of

[4]           Schedule 5, paragraph 2.1 (b)

omit

$255

insert

$265

[5]           Further amendments — Schedule 5, Part 1, column 4

 

Provision

omit

insert

Item 1.1

620

645

Item 1.2

5 370

5 545

Item 1.3, paragraph (a)

32 930

34 005

Item 1.3, paragraph (b)

25 320

26 145

Item 1.5, paragraphs (a) and (b)

820

850

Item 1.5, paragraphs (c), (d) and (e)

620

645

Item 1.7

11 330

11 700

Item 1.8

220

240

Item 1.9, paragraph (a)

18 380

18 980

Item 1.9, paragraph (b)

36 390

37 575

Item 1.9, paragraph (c)

25 320

26 145

Item 1.9, paragraph (d)

17 690

18 265

Item 1.9, paragraph (e)

16 130

16 655

Item 1.9, paragraph (f)

13 900

14 355

Item 1.10, paragraph (a)

11 030

11 390

Item 1.10, paragraph (b)

21 830

22 545

Item 1.10, paragraph (c)

15 190

15 685

Item 1.10, paragraph (d)

9 680

9 995

Item 1.10, paragraph (e)

8 340

8 615

Item 1.12

255

265

Item 1.13

2 390

2 470

Item 1.14

4 380

4 525

Item 1.15

280

290

Notes

1.       These Regulations amend Statutory Rules 2002 No. 236.

2.       Notified in the Commonwealth of Australia Gazette on 26 June 2003.