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Department of Health and Ageing [2008] AUSStaCSDLM 202 (27 November 2008)


DEPARTMENT OF HEALTH AND AGEING

Conformity Assessment Standards Order
(Standard for Quality Management Systems and
Quality Assurance Techniques) 2008 under
s. 41DC of the Therapeutic Goods Act 1989

[F2008L04337]
Made
14/11/2008
Tabled
26/11/2008 S
26/11/2008 HR
Summary
Specifies conformity assessment standards for quality assurance techniques for the manufacture of medical devices that are intended to be supplied in a sterile state.

Health Insurance (Positron Emission
Tomography) Determination 2008 (No. 2) under
s. 3C(1) of the Health Insurance Act 1973

[F2008L04320]
Made
10/11/2008
Tabled
24/11/2008 S
24/11/2008 HR
Summary
Provides for the payment of Medicare benefits for PET services.

Health Insurance (Positron Emission
Tomography) Facilities Determination 2008
under s. 3C(1) of the Health Insurance Act 1973

[F2008L04319]
Made
13/11/2008
Tabled
24/11/2008 S
24/11/2008 HR
Summary
Specifies the availability of Medicare items for Positron Emission Tomography services.

Instrument No. PB 110 of 2008 under s. 84AF
of the National Health Act 1953

[F2008L04302]
Made
03/11/2008
Tabled
24/11/2008 S
24/11/2008 HR
Summary
Determines, for specified brands of pharmaceutical items, the responsible persons for those brands.

Instrument No. PB 111 of 2008 under
paragraph 98C(1)(b) of the National Health
Act 1953

[F2008L04303]
Made
03/11/2008
Tabled
24/11/2008 S
24/11/2008 HR
Summary
Specifies amendments to the conditions under which payments will be made in respect of supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners.

Instrument No. PB 112 of 2008 under s. 84AH
of the National Health Act 1953

[F2008L04304]
Made
03/11/2008
Tabled
24/11/2008 S
24/11/2008 HR
Summary
Determines that certain pharmaceutical products are exempt items for the purposes of the Act.

Medical Device Standards Order (Standards for
Biological Safety of Medical Devices) 2008 under
s. 41CB of the Therapeutic Goods Act 1989

[F2008L04338]
Made
14/11/2008
Tabled
26/11/2008 S
26/11/2008 HR
Summary
Specifies standards that are relevant
to the biological safety of medical devices.

Medical Device Standards Order (Standards for
Medical Devices Required to be Sterile) 2008
under s. 41CB of the Therapeutic Goods Act 1989

[F2008L04336]
Made
14/11/2008
Tabled
24/11/2008 S
24/11/2008 HR
Summary
Specifies standards for quality assurance techniques for the manufacture of medical devices that are intended to be supplied in a sterile state.

Medical Device Standards Order (Standards for
Natural Latex Rubber Condoms) 2008 under
s. 41CB of the Therapeutic Goods Act 1989

[F2008L04335]
Made
14/11/2008
Tabled
24/11/2008 S
24/11/2008 HR
Summary
Specifies standards that are applicable to natural latex rubber condoms.

National Health Security (SSBA Standards)
Determination 2008 under s. 35(1) of the
National Health Security Act 2007

[F2008L04331]
Made
13/11/2008
Tabled
26/11/2008 S
26/11/2008 HR
Summary
Specifies standards relating to
security-sensitive biological agents.

Private Health Insurance (Health Benefits Fund
Administration) Amendment Rules 2008 (No. 2)
under s. 333-25 of the Private Health Insurance
Act 2007

[F2008L04308]
Made
23/10/2008
Tabled
24/11/2008 S
24/11/2008 HR
Summary
Extends the operation of Rule 12A
of the Principal Rules until 01 January 2010.

Therapeutic Goods (Emergency) Exemption
2008 (No. 4) under ss. 18A(1) and 18A(2)(a)
of the Therapeutic Goods Act 1989

[F2008L04340]
Made
11/11/2008
Tabled
24/11/2008 S
24/11/2008 HR
Summary
Permits the addition to the National Medicines Stockpile of an unregistered immunoglobulin treatment.


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