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.

On this page: Medical devices notices | Medical device standards orders | Conformity assessment standards orders | Guidance on MDSOs & CASOs

Medical devices notices

• Therapeutic Goods (Articles that are not Medical Devices) Order No. 2 of 2017
  Declares that a material or other article that through chemical means is intended to change, or that acts by causing change to, the pH level of body fluids including in a body orifice, is not a medical device for the purposes of the Act
• Therapeutic Goods (Articles that are not Medical Devices) Order No.1 2017
  Declares that riboflavin products instilled into the eye(s) that are used in the treatment of disorders of the eye which cause structural changes within the cornea are not medical devices
• Therapeutic Goods (Articles that are Medical Devices) Specification 2014
  Specifies that the instruments, apparatus, appliances, materials or other articles described in this Specification are medical devices for the purposes of the Therapeutic Goods Act 1989
• Therapeutic Goods (Articles that are not Medical Devices) Order No. 1 of 2010
  Declaration that the articles, or classes of articles, described in this Order are not medical devices for the purposes of the Act
• Therapeutic Goods (Articles that are not Medical Devices) Order No. 2 of 2004
  Declaration that the articles, or classes of articles, described in this Order are not medical devices for the purposes of the Act
• Therapeutic Goods (Goods that are not Therapeutic Devices) Order No. 1 of 1992
  Declaration that the articles, or classes of articles, described in this Order are not medical devices for the purposes of the Act

Medical device standards orders

• Medical Device Standards Order (Standards for Biological Safety Of Medical Devices) 2008
• Medical Device Standards Order (Standards for Clinical Evidence) 2008
• Medical Device Standards Order (Standards for Medical Devices Required to be Sterile) 2008
• Medical Device Standards Order (Standards for Natural Latex Rubber Condoms) 2008
• Medical Device Standards Order (Standards for Risk Management) 2008

Conformity assessment standards orders

• Conformity Assessment Standards Order (Standard for Quality Management Systems and Quality Assurance Techniques) 2008
• 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

Guidance on MDSOs & CASOs

• Guidance on Medical Device Standards Order (Standards for Clinical Evidence) 2008
  Specifies medical device standards relevant to medical devices that require clinical evidence in order to demonstrate compliance with the essential principles
• Guidance on Medical Device Standards Order (Standards for Risk Management) 2008
  Specifies relevant medical device standards for the risk analysis and risk management methods concerning medical devices