Therapeutic Goods (Articles that are not Medical Devices) Order No. 1 of 2010

COMMONWEALTH OF AUSTRALIA

Therapeutic Goods Act 1989

Therapeutic Goods (Articles that are not Medical Devices) Order No. 1 of 2010

I, Ruth Lopert, delegate of the Secretary to the Department of Health and Ageing for the purposes of subsection 41BD(3) of the Therapeutic Goods Act 1989 (the Act), hereby:

1. revoke Therapeutic Goods (Articles that are not Medical Devices) Order No. 1 of 2004, dated 27 February 2004; and
2. make this Order to declare that the articles, or classes of articles, described in paragraph 3 of this Order are not, for the purposes of the Act, medical devices.

Dated 9 June 2010

Ruth Lopert
Delegate of the Secretary to 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 2010.

Commencement

2. This Order commences on 1 July 2010.

Articles declared not to be medical devices

3. For the purposes of 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; and
   6. hospital grade or household grade disinfectants that are claimed to be sterilants, fungicides, sporicides, tuberculocides or virucides.