Therapeutic Goods (Medical Devices) Amendment Regulations 2003 (No. 2)1

Statutory Rules 2003 No. 2592

I, PHILIP MICHAEL JEFFERY, Governor-General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following Regulations under the Therapeutic Goods Act 1989.

Dated 9 October 2003

P. M. JEFFERY

Governor-General

By His Excellency’s Command

TRISH WORTH

Parliamentary Secretary to the Minister for Health and Ageing

Contents

1 Name of Regulations

2 Commencement

3 Amendment of Therapeutic Goods (Medical Devices) Regulations 2002

Schedule 1 Amendments commencing on gazettal

Schedule 2 Amendments commencing on 4 October 2007

1 Name of Regulations

These Regulations are the Therapeutic Goods (Medical Devices) Amendment Regulations 2003 (No. 2).

2 Commencement

These Regulations commence as follows:

(a) on gazettal — regulations 1 to 3 and Schedule 1;

(b) on 4 October 2007 — Schedule 2.

3 Amendment of Therapeutic Goods (Medical Devices) Regulations 2002

Schedules 1 and 2 amend the Therapeutic Goods (Medical Devices) Regulations 2002.

Schedule 1 Amendments commencing on gazettal

(regulation 3)

[1] Schedule 1, paragraph 13.2 (2) (b)

after

of the devices

insert

for supply

[2] Schedule 1, clause 13.3, table, item 1, column 2

omit

trade

insert

trading

[3] Schedule 1, clause 13.4, table, item 1, column 2

omit

trade

insert

trading

Schedule 2 Amendments commencing on 4 October 2007

(regulation 3)

[1] Regulation 10.2, heading

substitute

10.2 Information about sponsor

[2] Subregulation 10.2 (1)

substitute

(1) The sponsor of a medical device must ensure that the sponsor’s name and address are:

(a) provided with the device in such a way that a user of the device can readily identify the sponsor; and

(b) located in accordance with clause 13.2 in Schedule 1.

Penalty: 10 penalty units.

[3] Schedule 1, subclause 13.2 (3)

after

under

insert

subregulation 10.2 (1) or