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.

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

Medical devices notices

• Therapeutic Goods (Medical Devices - Specified Articles) Instrument 2020
  Specifies a particular class of non-sterile personal protective equipment and safety apparel to be medical devices under subsection 41BD(2B) of the Therapeutic Goods Act 1989 (the Act)
• Therapeutic Goods (Materials or Articles that are Not Medical Devices) Order 2019
  Declares that some nappy rash products are not to be medical devices 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 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 devices determinations

• Therapeutic Goods (Medical Devices - Information that Must Accompany Application for Inclusion) Determination 2018
  Determines the kind and form of information that must accompany an application for a kind of medical device to be included in the Australian Register of Therapeutic Goods
• Therapeutic Goods (Overseas Regulators) Determination 2018
  Specifies the specific entities that are determined to be an overseas regulator for the purposes of subsection 41BIB(1) of the Act
• Therapeutic Goods (Excluded Goods) Determination 2018
  Specifies products that are excluded goods for the purposes of the Act
• Therapeutic Goods (Excluded Goods) Amendment (Personalised Medical Devices) Determination 2021
  Specifies certain kinds of lower risk devices, such as spectacle frames and medicament trays, as excluded goods for the purposes of the Act
• Therapeutic Goods (Excluded Goods) Amendment (Borderline Products - COVID-19) Determination 2021
  Specifies certain borderline products, such as cleaning and sanitary products, as excluded goods for the purposes of the Act

Medical device standards orders

• Medical Device Standards Order (Endotoxin Requirements for Medical Devices) 2018

Conformity assessment standards orders

• Therapeutic Goods (Conformity Assessment Standard for Quality Management Systems) Order 2019

Guidance on MDSOs & CASOs

• Guidance on Therapeutic Goods (Conformity Assessment Standard for Quality Management Systems) Order 2019