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 - Donor Screening) (COVID-19 Emergency) Exemption 2020
  Applies to medical devices that are Class 4 in-house IVD medical devices for COVID-19 donor screening. The effect of the instrument is to exempt these medical devices from certain requirements under the Therapeutic Goods Act 1989 in order to deal with the threat to public health caused by the COVID-19 emergency.
• 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
• Therapeutic Goods (Medical Devices - Ventilators) (COVID-19 Emergency) Exemption 2020
  Applies to medical devices that are ventilators manufactured and supplied to hospitals in Australia in accordance with minimum technical requirements. The effect of the instrument is to exempt these ventilators from certain requirements under the Therapeutic Goods Act 1989 in order to deal with the threat to public health caused by the COVID-19 emergency.
• Therapeutic Goods (Medical Devices - Face Masks and Other Articles) (COVID-19 Emergency) Exemption 2020
  Applies to medical devices that are disposable face masks, disposable gloves, disposable gowns, and protective eye wear, which are designed to prevent the transmission of organisms. Exempts these medical devices from certain requirements under the Therapeutic Goods Act 1989 in order to deal with the threat to public health caused by the COVID-19 emergency.
• Therapeutic Goods (Medical Devices - Accredited Pathology Laboratories) (COVID-19 Emergency) Exemption 2020
  Applies to medical devices that are IVD medical devices used for the diagnosis, confirmatory testing, prevention, monitoring, treatment or alleviation of coronavirus disease (COVID-19). Exempts these medical devices from certain requirements under the Therapeutic Goods Act 1989 in order to deal with the threat to public health caused by the COVID-19 emergency.
• Therapeutic Goods (Medical Devices - Novel Coronavirus) (Emergency) Exemption 2020
  Exempts certain kinds of medical devices (in practice, principally in vitro diagnostic medical devices) from specified requirements in the Therapeutic Goods Act 1989 (including the requirement to be included in the Australian Register of Therapeutic Goods) so that they can be made available urgently in Australia in order to deal with an actual threat to public health caused by the novel coronavirus emergency
• 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) Amendment (COVID-19 Measures - Class 1 IVD Medical Devices) Determination 2020
  This instrument amends the Therapeutic Goods (Medical Devices - Information that Must Accompany Application for Inclusion) Determination 2018 to specify that a declaration of conformity must accompany an application for inclusion in relation to Class 1 in vitro diagnostic (IVD) medical devices.
• Therapeutic Goods (Medical Devices - Information that Must Accompany Application for Inclusion) Amendment (COVID-19 Measures - Class I Medical Devices) Determination 2020
  This instrument amends the Therapeutic Goods (Medical Devices - Information that Must Accompany Application for Inclusion) Determination 2018 to specify that a declaration of conformity must accompany an application for inclusion in relation to certain Class I medical devices and Class I system or procedure packs.
• 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

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

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