Therapeutic Goods (Medical Devices) Amendment Regulations 2011 (No. 2) (Cth)
Therapeutic Goods (Medical Devices) Amendment Regulations 2011 (No. 2)1
Select Legislative Instrument 2011 No. 104
I, QUENTIN BRYCE, 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 16 June 2011
QUENTIN BRYCE
Governor-General
By Her Excellency’s Command
CATHERINE KING
Parliamentary Secretary for Health and Ageing
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Name of Regulations
These Regulations are the Therapeutic Goods (Medical Devices) Amendment Regulations 2011 (No. 2).
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Commencement
These Regulations commence on 1 July 2011.
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Amendment of Therapeutic Goods (Medical Devices) Regulations 2002
Schedule 1 amends the Therapeutic Goods (Medical Devices) Regulations 2002.
Schedule 1 Amendments
(regulation 3)
[1] Before regulation 8.1
insert
8.1AMatters for which information and documents can be requested
For paragraph 41JA (j) of the Act, the following matters are prescribed:
(a)whether the devices are medical devices;
(b)whether the devices are intended for a specified purpose, as ascertained under subsection 41BD (2) of the Act;
(c)whether the devices are correctly classified under Division 3.1 of Part 3;
(d)whether procedures are in place, including a written agreement with the manufacturer of the devices, that require the manufacturer to make available information mentioned in paragraph 41FD (e) or (g) of the Act;
(e)whether the devices contain substances that are prohibited imports under the Customs Act 1901;
(f)whether the devices are to be used exclusively for one or more of the purposes specified under section 41BEA of the Act;
(g)the accuracy and completeness of information included in or with the application.
[2] Schedule 3A, clause 11
omit
destroy the devices.
insert
direct a person, other than the person who has control over the devices, to destroy the devices in the way directed.
[3] Table of amendments — fees
|
Provision |
omit each mention of |
insert |
| Paragraph 9.4 (2) (b) | $3 220 | $3 330 |
| Schedule 5, item 1.1 | 790 | 820 |
| Schedule 5, item 1.2 | 6 920 | 7 160 |
| Schedule 5, item 1.2 | 6 970 | 7 210 |
| Schedule 5, item 1.3 | 42 500 | 43 900 |
| Schedule 5, item 1.3 | 32 700 | 33 800 |
| Schedule 5, item 1.3A | 23 900 | 24 700 |
| Schedule 5, item 1.3A | 51 000 | 52 700 |
| Schedule 5, item 1.3A | 12 500 | 12 900 |
| Schedule 5, item 1.3A | 3 010 | 3 110 |
| Schedule 5, item 1.3A | 33 000 | 34 100 |
| Schedule 5, item 1.3A | 21 000 | 21 700 |
| Schedule 5, item 1.5 | 1 050 | 1 090 |
| Schedule 5, item 1.5 | 810 | 840 |
| Schedule 5, item 1.7 | 14 600 | 15 100 |
| Schedule 5, item 1.8 | 280 | 290 |
| Schedule 5, item 1.9 | 23 800 | 24 600 |
| Schedule 5, item 1.9 | 46 900 | 48 500 |
| Schedule 5, item 1.9 | 32 700 | 33 800 |
| Schedule 5, item 1.9 | 22 800 | 23 600 |
| Schedule 5, item 1.9 | 20 800 | 21 500 |
| Schedule 5, item 1.9 | 17 800 | 18 400 |
| Schedule 5, item 1.9A | 23 900 | 24 700 |
| Schedule 5, item 1.9A | 51 000 | 52 700 |
| Schedule 5, item 1.9A | 12 500 | 12 900 |
| Schedule 5, item 1.9A | 3 010 | 3 110 |
| Schedule 5, item 1.9A | 33 000 | 34 100 |
| Schedule 5, item 1.9A | 21 000 | 21 700 |
| Schedule 5, item 1.10 | 14 300 | 14 800 |
| Schedule 5, item 1.10 | 28 200 | 29 200 |
| Schedule 5, item 1.10 | 19 700 | 20 400 |
| Schedule 5, item 1.10 | 12 500 | 12 900 |
| Schedule 5, item 1.10 | 10 800 | 11 200 |
| Schedule 5, item 1.12 | 330 | 340 |
| Schedule 5, item 1.13 | 3 080 | 3 180 |
| Schedule 5, item 1.14 | 5 650 | 5 840 |
| Schedule 5, item 1.14A | 5 500 | 5 690 |
| Schedule 5, item 1.15 | 360 | 370 |
| Schedule 5, item 1.17 | 810 | 840 |
| Schedule 5, paragraph 2.1 (b) | $330 | $340 |
Note
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All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003. See
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