Hospital grade or household/ commercial grade disinfectant liquids, sprays, wipes*, sponges and aerosols that do not make specific claims** and that are:

• Not intended for use internally or on skin
• Not intended for use on a medical device
• Are intended for use on inanimate objects such as hard and soft surfaces (for example curtains, floors, bench tops, lounge furniture and carpets)

Exempt disinfectant

These products are not required to be included in the Australian Register of Therapeutic Goods before they are supplied to the market but they must still meet all regulatory requirements as set out in the relevant legislation and guidance

Therapeutic Goods Act 1989

Therapeutic Goods Regulations 1990

Therapeutic Goods (Standard for Disinfectants and Sanitary Products) (TGO 104) Order 2019

TGA instructions for disinfectant testing

Exempt Disinfectant Guidance

Disinfectant Claim Guide

TGA Advertising Code

Poisons Standard (SUSMP)

Hospital grade or household/ commercial grade disinfectant liquids, sprays, wipes, sponges and aerosols that make specific claims** to kill microorganisms and that are;

• Not intended for use internally or on skin
• Not intended for use on a medical device
• Are intended for use on inanimate objects such as hard and soft surfaces (for example curtains, floors, bench tops, lounge furniture and carpets)

Listed disinfectant

These products are required to be included in the Australian Register of Therapeutic Goods before they are supplied to the market and must meet all regulatory requirements as set out in the relevant legislation and guidance

Therapeutic Goods Act 1989

Therapeutic Goods Regulations 1990

Therapeutic Goods (Standard for Disinfectants and Sanitary Products) (TGO 104) Order 2019

TGA instructions for disinfectant testing

Listed Disinfectant Guidance

Disinfectant Claim Guide

TGA Advertising Code

Poisons Standard (SUSMP)

Liquids, sprays, wipes and aerosols that are intended to be used on medical devices

Medical devices

These products must be included in the Australian Register of Therapeutic Goods as a Class IIb medical device before they can be supplied

Guidelines for the evaluation of sterilants and disinfectants*

Therapeutic Goods Act 1989

Therapeutic Goods (Medical Devices) Regulations 2002

TGA Advertising Code

Poisons Standard (SUSMP)

* These guidelines are no longer used as a regulatory instrument and are now provided for information and guidance to assist sponsors with meeting the testing requirements for disinfectant products that are regulated as a medical device only. No section of the Guidelines should be used when assessing a Listed disinfectant that is regulated as outlined earlier in this table.

Cleaners intended to be used on medical devices that do not claim to be a device disinfectant or sterilant

Medical devices

These products must be included in the Australian Register of Therapeutic Goods as a Class I medical device before they can be supplied

Therapeutic Goods Act 1989

Therapeutic Goods (Medical Devices) Regulations 2002

TGA Advertising Code

Poisons Standard (SUSMP)

Bedding, clothing, towels and other articles made principally of fabric that are intended to be used primarily on or in close contact with the human body; and are represented expressly to be effective against the virus that causes COVID-19

Medical devices

Therapeutic Goods (Medical Devices-Specified Articles) Instrument 2020

General cleaners in all forms without disinfectant claims

General consumer product

These products are not regulated by the TGA

Detergent products where the ingredients do not produce a microbiocidal effect

General consumer product

These products are not regulated by the TGA

Sanitisers - products which implicitly or explicitly reduce micro‑organisms other than viruses to a sanitary level and which while making specific claims against a limited number of micro‑organisms are the subject of user specifications, or are subject to a recognised industry standard and are not for the retail market

General consumer product

These products are not regulated by the TGA

Skin antiseptic products

(including alcohol swabs that claim to disinfect)

Over-the-counter medicines

These products must be included in the Australian Register of Therapeutic Goods as an over-the-counter medicine before they can be supplied

Guidance and legislation governing over-the-counter medicines can be accessed at OTC medicines regulation basics

Alcohol swabs that claim to clean the skin only (and do not claim to disinfect or act as an antiseptic)

Medical devices

These products must be included in the Australian Register of Therapeutic Goods as a Class I medical device before they can be supplied

Therapeutic Goods Act 1989

Therapeutic Goods (Medical Devices) Regulations 2002

TGA Advertising Code

Poisons Standard (SUSMP)

Antibacterial skin care products where claims are limited to general low level activity against bacteria (for example, "Kill 99.9% of bacteria")

General consumer product

These products are not regulated by the TGA but must not contain substances that are included in Schedule 2, 3, 4 or 8 of the Poisons Standard (SUSMP)

The following products are typically applied to surfaces to provide a long lasting protective barrier are excluded from regulation:

• Surface modifying coatings
• Protective barriers, films and coatings

General consumer product

Therapeutic Goods (Excluded Goods) Determination 2018

The following products are excluded from regulation under different legislative mechanisms:

• Disinfectant and sterilant gases
• Products represented to be for antifungal use only
• A disinfectant or sanitiser registered under the Agricultural and Veterinary Chemicals Code Act 1994 for which no claim or representation for disinfectant use is made other than a use which is registered for the disinfectant
• Disinfectants or sanitisers that are represented to be suitable for the treatment of drinking water only
• Contact lens care products

Excluded goods

These products are excluded from regulation by the TGA. While they may be required to meet relevant legislative requirements under consumer legislation, they are not required to meet any of the legislative requirements regulated by the TGA

Therapeutic Goods (Excluded Goods) Determination 2018

Therapeutic Goods (Declared Goods) Order 2019

Therapeutic Goods (Excluded Goods) Order No. 1 of 2011