I, Cheryl McRae, a delegate of the Secretary of the Department of Health for the purposes of section 41BD of the Therapeutic Goods Act 1989 (the Act), make the following order under subsection 41BD(3) of the Act.

Dated 17 August 2017

(Signed by)

CHERYL MCRAE

Assistant Secretary, Medical Devices Branch

Medical Devices & Product Quality Division

Health Products Regulation Group

Department of Health

1 Name of order

  This order is the Therapeutic Goods (Articles that are not Medical Devices) Order  No. 2 of 2017.

2 Commencement

This order commences on the day after this notifiable instrument is registered.

3 Authority

  This order is made under subsection 41BD(3) of the Therapeutic Goods Act 1989 (the Act).

4 Articles that are not medical devices

  Pursuant to subsection 41BD(3) of the Act I declare that a material or other article that through chemical means is intended to change, or that acts by causing change to, the pH level of body fluids, including in a body orifice, is not, for the purposes of the Act, a medical device.

            Note: body orifice is defined in the Dictionary of the Therapeutic Goods (Medical Devices) Regulations 2002)