Federal Register of Legislation - Australian Government

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SLI 2008 No. 270 Regulations as made
These Regulations amend the Therapeutic Goods (Medical Devices) Regulations 2002 to include an exemption from requirements of the Act for a medical device, to enable stockpiling. This would allow Australia to maintain its preparedness for a public health emergency.
Administered by: Health
Registered 18 Dec 2008
Tabling HistoryDate
Tabled HR03-Feb-2009
Tabled Senate03-Feb-2009
Date of repeal 19 Mar 2014
Repealed by Health (Spent and Redundant Instruments) Repeal Regulation 2014

Therapeutic Goods (Medical Devices) Amendment Regulations 2008 (No. 2)1

Select Legislative Instrument 2008 No. 270

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 12 December 2008

QUENTIN BRYCE

Governor‑General

By Her Excellency’s Command

JAN MCLUCAS


1              Name of Regulations

                These Regulations are the Therapeutic Goods (Medical Devices) Amendment Regulations 2008 (No. 2).

2              Commencement

                These Regulations commence on the day after they are registered.

3              Amendment of Therapeutic Goods (Medical Devices) Regulations 2002

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


Schedule 1        Amendment

(regulation 3)

  

[1]           Schedule 4, Part 2, table, after item 2.8

insert

2.9

Medical device that is a system or procedure pack under section 41BF of the Act that:

   (a)  is imported, supplied or manufactured by or on behalf of the Commonwealth; and

   (b)  is certified by the Secretary to be emergency supplies for stockpiling for use in the event of a public health emergency.

   (a)  The device must be imported, supplied or manufactured on or before 31 December 2010.

   (b)  The importation, supply or manufacture of the device must be approved in writing by the Secretary.

   (c)  The use and supply of the device must be in accordance with the written approval of the Secretary.

   (d)  Records in relation to the importation, supply or manufacture of the device must be kept in accordance with the directions of the Secretary.

 

 

   (e)  The disposal of any unused device must be in accordance with the directions of the Secretary.


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.