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Therapeutic Goods (Articles that are not Medical Devices) Order No. 1 of 2004

Published in the Commonwealth of Australia Gazette, No. GN 16, 21 April 2004

COMMONWEALTH OF AUSTRALIA

Therapeutic Goods Act 1989

Therapeutic Goods (Articles that are not Medical Devices) Order No. 1 of 2004

I, Terry Slater, delegate of the Secretary of the Department of Health and Ageing for the purposes of subsection 41BD(3) of the Therapeutic Goods Act 1989 (the Act), make this Order to declare that the articles described in paragraph 3 of this Order are not, for the purposes of the Act, medical devices.

Dated 27th February 2004

Terry Slater
Delegate of the Secretary of the Department of Health and Ageing

Citation

  1. This Order may be cited as the Therapeutic Goods (Articles that are not Medical Devices) Order No. 1 of 2004.

Commencement

  1. This Order commences on the day it is published in the Gazette.
  2. For the purposes of the subsection 41BD(3) of the Act, the following articles, or classes of articles, are declared not to be medical devices:
    1. chemical oxygen generators;
    2. in-vivo imaging agents injected, ingested, or otherwise instilled into the body;
    3. an article that is intended to administer a medicine in such a way that the medicine and the article form a single integral product which is intended exclusively for use in the given combination and which is not reusable (may be multi-dose);
    4. articles incorporating tissues, cells or substances of human origin, other than medical devices incorporating stable derivatives of either human blood or human plasma that act on, or are likely to act on, the human body in a way that is ancillary to the device;
    5. articles incorporating viable tissues, cells or substances of animal origin;
    6. diagnostic goods for in vitro use;
    7. articles used for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination;
    8. articles that are described in item 3, Part 1 of Schedule 3 and in Part 2 of Schedule 3 of the Therapeutic Goods Regulations, where such articles have been custom-made for particular patients.

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