Medical device notices and standards orders

Legislation on this site should be accessed from the official versions. Occasionally, these instruments are amended and replaced or new ones are made.

Medical device notices

• Therapeutic Goods (Articles that are Not Medical Devices) Declaration 2023
  Declares that certain articles are not medical devices for the purposes of the Therapeutic Goods Act 1989 (the Act).
• 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 Act.

Medical device 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 ARTG.
• 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 excluded for the purposes of the Act. For example, spectacle frames and medicament trays.
• Therapeutic Goods (Excluded Goods) Amendment (Borderline Products - COVID-19) Determination 2021
  Specifies certain borderline products excluded for the purposes of the Act. For example, cleaning and sanitary products.

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 and CASOs

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