Therapeutic Goods (Restricted Representations - Contact Lenses and Spectacle Lenses) Permission 2025

I, Michael Shum, as delegate of the Secretary of the Department of Health, Disability and Ageing, make the following permission.

Dated 30 September 2025

Michael Shum

Acting Assistant Secretary
Regulatory Compliance Branch
Health Products Regulation Group
Department of Health, Disability and Ageing

Contents

1. Name
2. Commencement
3. Authority
4. Definitions
5. Permission

Schedule 1—Permission

1 Name

This instrument is the Therapeutic Goods (Restricted Representations—Contact Lenses and Spectacle Lenses) Permission 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Note: This table relates only to the provisions of this instrument as originally made.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 42DK of the Therapeutic Goods Act 1989.

4 Definitions

Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:

1. advertise;

2. included in the Register;

3. medical device;

4. Register;

5. Therapeutic Goods Advertising Code.

In this instrument:

Act means the Therapeutic Goods Act 1989.

Class I medical device has the same meaning as in the MD Regulations.

Class IIa medical device has the same meaning as in the MD Regulations.

intended purpose has the same meaning as in the MD Regulations.

MD Regulations means the Therapeutic Goods (Medical Devices) Regulations 2002.

prominently displayed or communicated has the same meaning as in the Therapeutic Goods Advertising Code.

restricted representation means a representation referred to in section 42DD of the Act.

specified goods means a medical device that:

1. is either:
   1. a contact lens that is classified as a Class IIa medical device; or
   2. a spectacle lens that is classified as a Class I medical device; and
2. is included in the Register; and
3. has an intended purpose, certified under section 41FD of the Act and accepted in relation to the inclusion of the device in the Register, that relates to the use of the device as corrective lenses for refractive errors of the eye or as lenses for controlling the progression of myopia.

5 Permission

For subsection 42DK(1) of the Act, in relation to each item in the table in Schedule 1, the restricted representations specified in column 2 (to the extent that those representations are restricted representations) are permitted to be used in advertisements about the specified goods, subject to the conditions (if any) specified in column 3.

Schedule 1—Permission

Note: See section 5.