Contents
1............ Short title............................................................................................ 1
2............ Commencement.................................................................................. 1
3............ Schedule(s).......................................................................................... 2
Schedule 1—Amendments 3
Part 1—Therapeutic Goods Act 1989 3
Part 2—Other Acts 5
Therapeutic Goods Amendment Act (No. 1) 2006 5
Therapeutic Goods Amendment (Medical Devices) Act 2002 5
A Bill for an Act to amend the law relating to therapeutic goods, and for related purposes
The Parliament of Australia enacts:
1 Short title
This Act may be cited as the Therapeutic Goods Amendment Act 2007.
2 Commencement
This Act commences, or is taken to have commenced, on 3 October 2007.
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Each Act that is specified in a Schedule to this Act is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this Act has effect according to its terms.
Schedule 1—Amendments
Part 1—Therapeutic Goods Act 1989
1 Subsection 9B(2)
Repeal the subsection, substitute:
(2) The registration or listing of any other medical device is taken to be cancelled at the time shown in the table:
| Time of cancellation of registration or listing |
| | Circumstances | Time |
| 1 | That kind of medical device is included in the Register under Chapter 4 before 4 October 2007 because of an application finally determined before that day | When that kind of medical device is included in the Register under Chapter 4 |
| 2 | An effective application for a conformity assessment certificate relating to that kind of medical device is made, but not finally determined, before 4 October 2007 | The end of 30 days after the application is finally determined or, if the application lapses, the later of the following times (or either of them if they are the same): (a) the time the application lapses; (b) the start of 4 October 2007 |
| 3 | An effective application to include that kind of medical device in the Register under Chapter 4 is made, but not finally determined, before 4 October 2007, and item 2 does not apply | Whichever one of the following times applies, or the earlier of them: (a) the time that kind of medical device is included in the Register under Chapter 4 (even if that time is before 4 October 2007); (b) the time the application is finally determined, if the application is unsuccessful when it is finally determined; or, if the application lapses, the later of the following times (or either of them if they are the same): (c) the time the application lapses; (d) the start of 4 October 2007 |
| 4 | None of items 1, 2 and 3 applies | The start of 4 October 2007 |
Note: 4 October 2007 is the fifth anniversary of the day Chapter 4 commenced.
(2A) For the purposes of subsection (2), an application is finally determined at the first time both the following conditions are met:
(a) a decision has been made under Part 4‑4 or 4‑5 whether or not to grant the conformity assessment certificate or include the kind of medical device in the Register (as appropriate);
(b) there is no longer any possibility of a change in the outcome of the decision in terms of the grant (or not) of the conformity assessment certificate or the inclusion (or not) of the kind of medical device in the Register.
For the purposes of paragraph (b), ignore any possibility of a discretion being exercised, after the period has ended, to extend a period for seeking review by a tribunal or court of the decision or for starting other proceedings (including appeals) arising out of the application, the decision or the review.
Note: In certain circumstances a decision may be taken to have been made under Part 4‑4 or Part 4‑5. For example, see section 41EH.
2 Chapter 3 (note to heading)
Repeal the note, substitute:
Note: This Chapter still applies to medical devices while they are registered or listed goods. Section 9B automatically cancels the registration or listing of those goods over time.
3 Chapter 4 (note to heading)
Repeal the note, substitute:
Note: This Chapter does not apply, and Chapter 3 (Medicines and other therapeutic goods that are not medical devices) still applies, to medical devices that are registered or listed goods. Section 9B automatically cancels the registration or listing of those goods over time.
Part 2—Other Acts
Therapeutic Goods Amendment Act (No. 1) 2006
4 Subsection 2(1) (table item 5)
Repeal the item.
5 Schedule 1 (Act heading after item 157)
Repeal the heading.
6 Item 158 of Schedule 1
Repeal the item.
Therapeutic Goods Amendment (Medical Devices) Act 2002
7 Subsection 2(1) (table item 3)
Repeal the item.
8 Schedule 2
Repeal the Schedule.