Federal Register of Legislation - Australian Government

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SLI 2011 No. 32 Regulations as made
These Regulations amend the Therapeutic Goods (Medical Devices) Regulations 2002 to clarify that systems or procedure packs (which are regulated as medical devices under the Act) may include one or more biologicals, and to make other consequential changes.
Administered by: Health
Registered 16 Mar 2011
Tabling HistoryDate
Tabled HR21-Mar-2011
Tabled Senate21-Mar-2011
Date of repeal 19 Mar 2014
Repealed by Health (Spent and Redundant Instruments) Repeal Regulation 2014

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

Select Legislative Instrument 2011 No. 32

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 10 March 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. 1).

2              Commencement

                These Regulations commence on the commencement of Schedule 1 to the Therapeutic Goods Amendment (2009 Measures No. 3) Act 2010.

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]           Subparagraph 3.10 (3) (a) (ii)

after

medicines,

insert

a biological or biologicals,

[2]           Paragraphs 3.10 (3) (b) and (c)

omit

medicine

insert

medicine, biological

[3]           Schedule 3, Part 7, paragraph 7.5 (2) (f)

omit

goods

insert

goods, or the biological number for each biological,

[4]           Schedule 3, Part 7, paragraph 7.5 (2) (g)

omit

medicine

insert

medicine, biological

[5]           Schedule 3, Part 7, subparagraph 7.5 (2) (h) (i)

omit

medicine

insert

medicine, biological


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.