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

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

Parliamentary Secretary to the Minister for Health and Ageing

1Name of Regulations

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

2Commencement

These Regulations commence on 1 July 2003.

3Amendment of Therapeutic Goods (Medical Devices) Regulations 2002

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

Schedule 1Amendments

(regulation 3)

  

[1]Paragraph 9.4 (2) (b)

omit

$2 500.

insert

$2 585.

[2]After regulation 9.5

insert

9.6Reduction 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:

1. (a)

   is in the interest of public health; and

2. (b)

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

9.7Reduction of assessment fees — abridged assessment

1. (1)

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

   1. (a)

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

   2. (b)

      item 1.9 (initial assessment under conformity assessment procedures);

   3. (c)

      item 1.10 (assessment consequent on a change to:

      1. (i)

         a medical device; or

      2. (ii)

         the quality management system applying to a medical device);

   4. (d)

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

   5. (e)

      item 1.16 (intermediate stage assessment or verification procedures).

2. (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:

   1. (a)

      the medical device to which the fee relates; or

   2. (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