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Therapeutic Goods (Materials or Articles that are Not Medical Devices) Order 2019

19 December 2019

I, Tracey Duffy, as delegate of the Secretary of the Department of Health, make the following order.

Dated 18 December 2019

Tracey Duffy
First Assistant Secretary
Medical Devices and Product Quality Division
Health Products Regulation Group
Department of Health


1 Name

This instrument is the Therapeutic Goods (Materials or Articles that are Not Medical Devices) Order 2019.

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.
Commencement information
Column 1 Column 2 Column 3
Provisions Commencement Date/Details
1. The whole of this instrument 1 January 2020. 1 January 2020

Note: This table relates only to the provisions of this instrument as originally made.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.

  1. 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 subsection 41BD(3) of the Therapeutic Goods Act 1989.

4 Definitions

Note: A number of expressions used in this instrument are defined in section 3 of the Act, including the following:
(a) medical device.

In this instrument:

Act means the Therapeutic Goods Act 1989.

5 Materials or articles that are not medical devices

Materials or articles that are unmedicated preparations for topical use for protecting against, or providing relief from, nappy rash symptoms by acting only as a barrier for the skin (whether or not the preparations also have a moisturising action), are declared not to be medical devices for the purposes of the Act.