Therapeutic Goods (Standard for Disinfectants and Sanitary Products) (TGO 104) Amendment Order 2025

I, Tracey Duffy, as delegate of the Minister for Health and Ageing, make the following order.

Dated 20 August 2025

Tracey Duffy

First Assistant Secretary
Medical Devices and Product Quality Division
Health Products Regulation Group
Department of Health, Disability and Ageing

Contents

1  Name

2  Commencement

3  Authority

4  Schedules

Schedule 1—Amendments

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

1  Name

  This instrument is the Therapeutic Goods (Standard for Disinfectants and Sanitary Products) (TGO 104) Amendment Order 2025.

2  Commencement

 (1) Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

 (2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

3  Authority

  This instrument is made under section 10 of the Therapeutic Goods Act 1989.

4  Schedules

  Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

Schedule 1—Amendments

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

1  Section 4 (definition of Instructions)

Repeal the definition, substitute:

Instructions means the TGA instructions for disinfectant testing (Version 4.0, August 2025) published by the Therapeutic Goods Administration, as in force or existing on 11 August 2025.

Note: The Instructions are published at www.tga.gov.au.

2  Paragraphs 13(4)(a) and (b)

Repeal the paragraphs, substitute:

 (a) pass any of the following tests:

 (i) the TGA Disinfectant Test under the conditions specified in Option A or Option B of that test;

 (ii) an appropriate test equivalent to the TGA Disinfectant Test as specified in Division 2 of Part 2 of the Instructions;

 (iii) an appropriate test for single or multiple use as specified in Division 2 of Part 2 of the Instructions; and

3  Paragraph 13(4)(c)

Renumber as paragraph (b).