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Therapeutic Goods Amendment (Medical Devices and Other Measures) Bill 2008 [2009]

2008-2009

 

The Parliament of the

Commonwealth of Australia

 

THE SENATE

 

 

 

 

As passed by both Houses

 

 

 

 

 

 

 

 

 

Therapeutic Goods Amendment (Medical Devices and Other Measures) Bill 2008

 

No.      , 2008

 

 

 

 

 

A Bill for an Act to amend the Therapeutic Goods Act 1989, and for related purposes

   

   



Contents

1............ Short title............................................................................................. 1

2............ Commencement................................................................................... 1

3............ Schedule(s)......................................................................................... 2

Schedule 1—Medical devices                                                                                            3

Therapeutic Goods Act 1989                                                                                      3

Schedule 2—Emergency exemption for therapeutic goods that are not medical devices                16

Therapeutic Goods Act 1989                                                                                    16

Schedule 3—Fit and proper person test                                                                  17

Therapeutic Goods Act 1989                                                                                    17

Schedule 4—Additional default standards                                                            26

Therapeutic Goods Act 1989                                                                                    26

Schedule 5—Information disclosure provisions                                                 33

Therapeutic Goods Act 1989                                                                                    33

Schedule 6—Advertising                                                                                                   36

Therapeutic Goods Act 1989                                                                                    36

Schedule 7—Other amendments                                                                                  39

Therapeutic Goods Act 1989                                                                                    39

 



A Bill for an Act to amend the Therapeutic Goods Act 1989, and for related purposes

The Parliament of Australia enacts:

1   Short title

                   This Act may be cited as the Therapeutic Goods Amendment (Medical Devices and Other Measures) Act 2008 .

2   Commencement

             (1)  Each provision of this Act 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.

 

Commencement information

Column 1

Column 2

Column 3

Provision(s)

Commencement

Date/Details

1.  Sections 1 to 3 and anything in this Act not elsewhere covered by this table

The day on which this Act receives the Royal Assent.

 

2.  Schedules 1 and 2

The day after this Act receives the Royal Assent.

 

3.  Schedule 3

A single day to be fixed by Proclamation.

However, if any of the provision(s) do not commence within the period of 6 months beginning on the day on which this Act receives the Royal Assent, they commence on the first day after the end of that period.

 

4.  Schedule 4

1 July 2009.

1 July 2009

5.  Schedules 5 to 7

The day after this Act receives the Royal Assent.

 

Note:          This table relates only to the provisions of this Act as originally passed by both Houses of the Parliament and assented to. It will not be expanded to deal with provisions inserted in this Act after assent.

             (2)  Column 3 of the table contains additional information that is not part of this Act. Information in this column may be added to or edited in any published version of this Act.

3   Schedule(s)

                   Each Act that is specified in a Schedule to this Act is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this Act has effect according to its terms.