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The regulation of disinfectants and sterilants

18 December 2018

Definitions for disinfectants and sterilants

A disinfectant is a substance which:

  • is recommended by its manufacturer for application to an inanimate object to kill micro-organisms; and
  • is not represented by the manufacturer to be suitable for internal use.

A sterilant is a chemical agent that kills all microbes with the result that the sterility assurance level of a microbial survivor is less than 10-6.

Sterilants are regulated as medical devices.

Applications to enter disinfectants on the Australian Register of Therapeutic Goods (ARTG) are submitted online using the TGA eBusiness Services system (eBS). New users need to establish a TGA e-business account.

Disinfection or sterilisation of medical devices

Disinfection or sterilisation of medical devices is undertaken to prevent the transmission of communicable diseases between the patient and other patients or the user.

All disinfectants and sterilants intended by the manufacturer to be used to disinfect medical devices are regulated in Australia as Class IIb accessories to medical devices. In Europe, some of these products are classified as Class IIa medical devices, and others are classified as Class IIb medical devices, depending on the type of device they are intended to disinfect.

Sponsors who wish to import these disinfectants and sterilants for use on medical devices need to ensure that the Australian regulatory requirements for Class IIb medical devices have been met by the manufacturer. Assessments performed for Europe for the purposes of affixing the CE Mark may not be sufficient for inclusion in the ARTG as a Class IIb medical device.

Compliance with essential principles

As accessories to medical devices,and disinfectants for a medical device must comply with the essential principles for quality, safety and performance.

Manufacturers must generate documentary evidence (a technical file) of compliance with the essential principles that are relevant to their disinfectant for a medical device. This documentation and evidence of its assessment (if necessary) must be available to an Australian sponsor before they can make an application for inclusion of the medical device in the ARTG.

More information is available in the Australian Regulatory Guidelines for Medical Devices (ARGMD).

Conformity assessment procedures to be followed

As disinfectants for medical devices are classified as Class IIb medical devices in Australia, any one of the following conformity assessment procedures (see Schedule 3 of the Therapeutic Goods (Medical Devices) Regulations 2002) can be followed:

  • Part 1 Full quality assurance procedures (other than clause 1.6)
  • Part 2 Type examination and Part 3 Verification procedures
  • Part 2 Type examination and Part 4 Production quality assurance procedures
  • Part 2 Type examination and Part 5 Product quality assurance procedures.

For specific information on the requirements of each procedure, refer to the Australian Regulatory Guidelines for Medical Devices (ARGMD).

Hard surface disinfectants

Hard surface disinfectants are regulated by the TGA and form part of the group of products referred to as "other therapeutic goods" (OTGs). OTGs are subject to the requirements for registered or listed goods under Chapter 3 of the Therapeutic Goods Act 1989. For guidance on the regulation of OTGs, please refer to Australian Medical Device Requirements Version 4 (DR4).

Disinfectants that are OTGs are subject to Therapeutic Goods Order 54 (Standard for Disinfectants and Sterilants) as a mandatory requirement.

Hard surface disinfectants include hospital, household and commercial grade disinfectants.

Hospital grade disinfectants

Hospital grade disinfectants are suitable for general purpose disinfection of building and fitting surfaces, and purposes not involving instruments or surfaces likely to come into contact with broken skin:

  • in premises used for:
    • the investigation or treatment of a disease, ailment or injury, or
    • procedures that are carried out involving the penetration of the human skin, or
  • in connection with:
    • the business of beauty therapy or hairdressing, or
    • the practice of podiatry.

but do not include:

  • antibacterial clothes preparations
  • sanitary fluids
  • sanitary powders
  • sanitisers.

Hospital grade disinfectants that make specific biocidal claims (virucidal, sporicidal, tuberculocidal, fungicidal or other) must be listed on the ARTG. Those without specific biocidal claims are exempt from the requirement to be included in the ARTG.

The Therapeutic Goods Regulations 1990 are to be changed so that registered disinfectants become listed on the ARTG. However, disinfectants with specific biocidal claims and those containing new chemical entities will still undergo a pre-market review.

Household and commercial grade disinfectants

Household and commercial grade disinfectants means a disinfectant that is not:

  • hospital grade disinfectants
  • antibacterial clothes preparations
  • sanitary fluids
  • sanitary powder
  • sanitisers.

Unless a household or commercial disinfectant has specific biocidal claims (that is, claims to kill some or all types of micro-organisms), these disinfectants are exempt from being entered on the ARTG. However, these disinfectants are required to comply with TGO 54.

Sanitisers and sanitary preparations

The claims made for sanitisers, sanitary preparations and antibacterial cleaning wipes determine how these products are regulated. These products can be:

Excluded goods

The following goods are excluded from being regulated as disinfectants, but may still be regulated as other types of therapeutic goods:

  • disinfectant and sterilant gases
  • antibacterial skin care products that do not contain any substance included in Schedules 2, 3, 4 or 8 to the Poisons Standard
  • antibiotics
  • a product that is 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
  • a disinfectant or sanitiser that is represented to be suitable for the treatment of water only
  • contact lens care products.