Medical devices notices & standards orders
If you intend to rely on any legislation referred to on this website, you should access copies of the official versions. These instruments are amended from time to time and may, on occasions, be replaced or new instruments made.
Medical devices notices
- Therapeutic Goods (Articles that are not Medical Devices) Order No. 2 of 2004
<http://www.tga.gov.au/legis/tgdev0402.htm> - Therapeutic Goods (Articles that are not Medical Devices) Order No. 1 of 2004
<http://www.tga.gov.au/legis/tgdev0401.htm> - Therapeutic Goods (Goods that are not Therapeutic Devices) Order No. 1 of 1992
<http://www.tga.gov.au/legis/tgdev9201.htm>
Standards orders
Medical device standards orders
- Medical Device Standards Order (Standards for Clinical Evidence) 2008
<http://www.tga.gov.au/legis/mdsoce2008.htm> - Medical Device Standards Order (Standards for Risk Management) 2008
<http://www.tga.gov.au/legis/mdsorm2008.htm> - Medical Device Standards Order No. 3: Medical device standards for medical devices required to be sterile
<http://www.tga.gov.au/devices/mdso3.htm>
Conformity assessment standards orders
- Conformity Assessment Standards Order No. 1 of 2005: Replacement of Conformity Assessment Standards Order No. 1: Conformity Assessment Standard for Quality Management Systems and Quality Assurance Techniques made on 20 February 2003
<http://www.tga.gov.au/devices/caso1-2005.htm> - Conformity Assessment Standards Order No. 2: Conformity assessment standards for quality assurance techniques for animal tissues and their derivatives utilised in the manufacture of medical devices
<http://www.tga.gov.au/devices/caso2.htm>