Federal Register of Legislation - Australian Government

Primary content

SLI 2011 No. 104 Regulations as made
These Regulations amend the Therapeutic Goods (Medical Devices) Regulations 2002 to increase certain fees by 3.4 per cent, to make changes to the collection of application and evaluation fees for prescription medicines and to make other amendments that are mainly of minor and machinery nature.
Administered by: Health
Registered 21 Jun 2011
Tabling HistoryDate
Tabled HR22-Jun-2011
Tabled Senate22-Jun-2011
Date of repeal 19 Mar 2014
Repealed by Health (Spent and Redundant Instruments) Repeal Regulation 2014

Commonwealth Coat of Arms

Therapeutic Goods (Medical Devices) Amendment Regulations 2011 (No. 2)1

Select Legislative Instrument 2011 No. 104

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 16 June 2011

QUENTIN BRYCE

Governor-General

By Her Excellency’s Command

CATHERINE KING


1              Name of Regulations

                These Regulations are the Therapeutic Goods (Medical Devices) Amendment Regulations 2011 (No. 2).

2              Commencement

                These Regulations commence on 1 July 2011.

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]           Before regulation 8.1

insert

8.1A        Matters for which information and documents can be requested

                For paragraph 41JA (j) of the Act, the following matters are prescribed:

                (a)    whether the devices are medical devices;

               (b)    whether the devices are intended for a specified purpose, as ascertained under subsection 41BD (2) of the Act;

                (c)    whether the devices are correctly classified under Division 3.1 of Part 3;

               (d)    whether procedures are in place, including a written agreement with the manufacturer of the devices, that require the manufacturer to make available information mentioned in paragraph 41FD (e) or (g) of the Act;

                (e)    whether the devices contain substances that are prohibited imports under the Customs Act 1901;

                (f)    whether the devices are to be used exclusively for one or more of the purposes specified under section 41BEA of the Act;

               (g)    the accuracy and completeness of information included in or with the application.

[2]           Schedule 3A, clause 11

omit

destroy the devices.

insert

direct a person, other than the person who has control over the devices, to destroy the devices in the way directed.

[3]           Table of amendments — fees

Provision

omit each mention of

insert

Paragraph 9.4 (2) (b)

$3 220

$3 330

Schedule 5, item 1.1

790

820

Schedule 5, item 1.2

6 920

7 160

Schedule 5, item 1.2

6 970

7 210

Schedule 5, item 1.3

42 500

43 900

Schedule 5, item 1.3

32 700

33 800

Schedule 5, item 1.3A

23 900

24 700

Schedule 5, item 1.3A

51 000

52 700

Schedule 5, item 1.3A

12 500

12 900

Schedule 5, item 1.3A

3 010

3 110

Schedule 5, item 1.3A

33 000

34 100

Schedule 5, item 1.3A

21 000

21 700

Schedule 5, item 1.5

1 050

1 090

Schedule 5, item 1.5

810

840

Schedule 5, item 1.7

14 600

15 100

Schedule 5, item 1.8

280

290

Schedule 5, item 1.9

23 800

24 600

Schedule 5, item 1.9

46 900

48 500

Schedule 5, item 1.9

32 700

33 800

Schedule 5, item 1.9

22 800

23 600

Schedule 5, item 1.9

20 800

21 500

Schedule 5, item 1.9

17 800

18 400

Schedule 5, item 1.9A

23 900

24 700

Schedule 5, item 1.9A

51 000

52 700

Schedule 5, item 1.9A

12 500

12 900

Schedule 5, item 1.9A

3 010

3 110

Schedule 5, item 1.9A

33 000

34 100

Schedule 5, item 1.9A

21 000

21 700

Schedule 5, item 1.10

14 300

14 800

Schedule 5, item 1.10

28 200

29 200

Schedule 5, item 1.10

19 700

20 400

Schedule 5, item 1.10

12 500

12 900

Schedule 5, item 1.10

10 800

11 200

Schedule 5, item 1.12

330

340

Schedule 5, item 1.13

3 080

3 180

Schedule 5, item 1.14

5 650

5 840

Schedule 5, item 1.14A

5 500

5 690

Schedule 5, item 1.15

360

370

Schedule 5, item 1.17

810

840

Schedule 5, paragraph 2.1 (b)

$330

$340


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.