Federal Register of Legislation - Australian Government

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This instrument declares that riboflavin products instilled into the eye(s) that are used in the treatment of disorders of the eye which cause structural changes within the cornea are not medical devices.
Administered by: Health and Aged Care
Registered 11 Jul 2017

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 28 June 2017

(Signed by)

 

CHERYL MCRAE

Assistant Secretary, Medical Devices Branch

Medical Devices & Product Quality Division

Health Products Regulation Group



 

1            Name of order

              This order is the Therapeutic Goods (Articles that are not Medical Devices) Order No.1 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

              For the purposes of subsection 41BD(3) of the Act, the following instruments, apparatuses, appliances, materials or other articles, or classes of instruments, apparatus, appliances, materials or other articles, are declared not to be medical devices:

 

(a)    Riboflavin products instilled into the eye(s) that are used in the treatment of disorders of the eye which cause structural changes within the cornea. These riboflavin products are used with UV-A light illumination in order to achieve an alteration of the normal chemical process of crosslinking of collagen, with the purpose of making the cornea stronger and more stable.