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Disinfectants, sterilants and sanitary products

Sterilants & disinfectants are regulated in a variety of ways in Australia, depending on the intended purpose of the product as discerned from the claims made in the instructions for use, labelling and promotional material.  The following table provides an overview of the manner in which these products are regulated in accordance with the following legislation:

More information about specific claims as referenced in the table below can be found in the Disinfectant Claim Guide.

Type of product

Regulation

Relevant legislation and guidance

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)

* A disinfectant wipe or sponge means a cloth, towel, towelette or sponge that is pre-moistened with a disinfectant and is recommended by its manufacturer for application of the disinfectant to an inanimate object to kill microorganisms  

** Virucidal, sporicidal, tuberculocidal, fungicidal or other biocidal activity are known as “specific claims”.  More information can be found in the Disinfectant Claim Guide.

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

TGO 104

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)

*disinfectant wipe or sponge means a cloth, towel, towelette or sponge that is pre-moistened with a disinfectant and is recommended by its manufacturer for application of the disinfectant to an inanimate object to kill microorganisms

** Virucidal, sporicidal, tuberculocidal, fungicidal or other biocidal activity are known as “specific claims”.  More information can be found in the Disinfectant Claim Guide.

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

TGO 104

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)

General cleaners in all forms without disinfectant claims

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 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 (Excluded Goods) Order No. 1 of 2011

Regulatory decisions and notices

Information about regulatory decisions made by the TGA for disinfectants & sterilants.