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

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

Contents

                        1     Name of Regulations                                                       2

                        2     Commencement                                                              2

                        3     Amendment of Therapeutic Goods (Medical Devices) Regulations 2002          2

Schedule 1              Amendments commencing on gazettal                          3

Schedule 2              Amendments commencing on 4 October 2007               4

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

1.       These Regulations amend Statutory Rules 2002 No. 236, as amended by 2003 No. 153.

2.       Notified in the Commonwealth of Australia Gazette on 16 October 2003.