Commonwealth Numbered Regulations Commonwealth Numbered RegulationsPart 1 -- Spinal implantable medical devices
Therapeutic Goods (Medical Devices) Regulations 2002
1 After paragraph 5.3(1)(b)
Insert:
(c) a medical device that is a spinal fusion implantable device;
Note: Examples of spinal fusion implantable devices include screws, cages, plates, hooks or rods that are intended to be used during spinal fusion surgical procedures.
2 Regulation 5.12 (heading)
Omit " relating to certain IVD medical devices ".
3 At the end of subregulation 5.12(1)
Add "or a kind of medical device that is a spinal fusion implantable device".
4 At the end of subregulation 5.12(1)
Add:
Note: Examples of spinal fusion implantable devices include screws, cages, plates, hooks or rods that are intended to be used during spinal fusion surgical procedures.
5 Subclause 3.4(2) of Schedule 2
Omit "and (4A)", substitute ", (4A) and (4B)".
6 After subclause 3.4(4A) of Schedule 2
Insert:
(4B) If the device:
(a) is intended by the manufacturer:
(i) to be a motion-preserving device for the spine (such as a spinal disc replacement); or
(ii) to come in contact with a person's spinal column; and
(b) is not a spinal fusion implantable device;
the device is classified as Class III.
Note: Examples of spinal fusion implantable devices include screws, cages, plates, hooks or rods that are intended to be used during spinal fusion surgical procedures.
Part 2 -- Active implantable medical devices
Therapeutic Goods (Medical Devices) Regulations 2002
7 Paragraph 1.6(b)
Repeal the paragraph.
8 Paragraph 1.7(1)(f)
Omit "Class AIMD medical device,".
9 Subregulation 3.1(1) (table)
Repeal the table, substitute:
| Medical device classifications |
|
|
| ||
| Column 1 | Column 2 | Column 3 |
Column 4 | Column 5 | |
| Item | Medical device | Class | Class |
Class | Class |
| 1 | Medical devices other than IVD medical devices |
I | IIa | IIb | III |
| 2 | IVD medical devices and in-house IVD medical devices | 1 | 2 | 3 | 4 |
10 Paragraph 3.1(2)(a)
Omit "column 3", substitute "column 2".
11 Paragraph 3.1(2)(b)
Omit "columns 4 to 6", substitute "columns 3 to 5".
12 Paragraph 3.1(2)(c)
Repeal the paragraph.
13 Regulation 3.6 (heading)
Omit " and Class AIMD medical devices ".
14 Subregulation 3.6(1)
Omit ", or a Class AIMD medical device,".
15 Paragraph 5.3(1)(e)
Repeal the paragraph.
16 Subparagraph 5.10(2)(a)(i)
Repeal the subparagraph.
17 Paragraph 5.11(1)(a)
Repeal the paragraph.
18 Subparagraph 8.1(b)(i)
Omit "Class AIMD medical device,".
19 Subclause 5.7(1) of Schedule 2
Omit "Class AIMD", substitute "Class III".
20 Paragraph 1.1(b) of Schedule 3
Omit ", Class AIMD medical device".
21 Clause 1.6 of Schedule 3 (heading)
Omit " , Class AIMD medical device ".
22 Subclause 1.6(1) of Schedule 3
Omit ", a Class AIMD medical device,".
23 Paragraph 1.9(1)(c) of Schedule 3
Omit ", Class AIMD medical device".
24 Subclause 3.5(1) of Schedule 3
Omit "Class AIMD medical device,".
25 Paragraph 3.6(1)(b) of Schedule 3
Omit "Class AIMD medical device,".
26 Subclause 4.7(1) of Schedule 3
Omit "Class AIMD medical device,".
27 Paragraph 4.8(1)(c) of Schedule 3
Omit "Class AIMD medical device,".
28 Schedule 4 (table item 1.1, column headed "Kinds of medical devices", paragraph (c))
Omit "Class AIMD medical device,".
29 Schedule 5 (table item 1.5)
Omit:
|
| (a) a Class AIMD medical device; |
| 1,340 |
30 Dictionary (definition of active implantable medical device or AIMD )
Omit "or AIMD ".
31 Dictionary (definition of Class AIMD medical device )
Repeal the definition.
32 Dictionary (subparagraph (b)(ii) of the definition of partial designation conformity assessment body determination (partial QMS or partial devices) )
Omit "or Class AIMD".
Part 3 -- Medical devices that administer medicines or biologicals by inhalation
Therapeutic Goods (Medical Devices) Regulations 2002
33 After subclause 3.1(2) of Schedule 2
Insert:
(2A) If the device is intended to be used to administer medicines or biologicals by inhalation:
(a) if the mode of action of the device has an essential impact on the efficacy and safety of the medicines or biologicals--the device is classified as Class IIb; or
(b) if the device is intended to treat a life-threatening condition--the device is classified as Class IIb; or
(c) if paragraphs (a) and (b) do not apply--the device is classified as Class IIa.
Part 4 -- Medical devices that are substances for introduction into the body
Therapeutic Goods (Medical Devices) Regulations 2002
34 Clause 2.4 of Schedule 2 (heading)
Omit " skin ", substitute " skin or mucous membrane ".
35 Subclause 2.4(1) of Schedule 2
After "skin", insert "or a mucous membrane".
36 Subparagraph 3.1(2)(c)(ii) of Schedule 2
Omit "mucous membrane", substitute "skin or mucous membrane".
37 At the end of clause 3.1 of Schedule 2
Add:
(4) If a device is composed of substances, or combinations of substances, that are:
(a) intended to be:
(i) introduced into the human body through a body orifice; or
(ii) applied to the skin; and
(b) absorbed by, or locally dispersed, in the human body after introduction or application;
the device is classified as follows:
(c) if the device, or its products of metabolism, are systemically absorbed by the human body in order to achieve the intended purpose--Class III;
(d) if the device achieves its intended purpose in the stomach or lower gastrointestinal tract and the device, or its products of metabolism, are systemically absorbed by the human body--Class III;
(e) if the device is applied to the skin, or in the nasal or oral cavity as far as the pharynx, and achieves its intended purpose on those cavities--Class IIa;
(f) in any other case--Class IIb.
38 Dictionary
Insert:
"injured skin or mucous membrane " means an area of skin or mucous membrane that has evidence of:
(a) a pathological change; or
(b) a change following:
(i) disease; or
(ii) a wound.
Part 5 -- Active medical devices for therapy
Therapeutic Goods (Medical Devices) Regulations 2002
39 At the end of clause 4.2 of Schedule 2
Add:
(4) An active medical device for therapy that includes a diagnostic function the purpose of which is to significantly determine patient management by the device is classified as Class III.
Example: An automated external defibrillator.
Part 6 -- Medical devices in direct contact with the heart etc.
Therapeutic Goods (Medical Devices) Regulations 2002
40 Clause 1.1 of Schedule 2
Omit "For", substitute "(1) For the purposes of".
41 At the end of clause 1.1 of Schedule 2
Add:
(2) For the purposes of determining whether a medical device is intended to be used continuously, disregard any temporary interruption or removal.
Example: A temporary interruption or removal in order to clean or disinfect the medical device.
42 After subclause 3.2(3) of Schedule 2
Insert:
(3A) If the device is intended by the manufacturer specifically to be used in direct contact with the heart, the central circulatory system or the central nervous system of a patient, the device is classified as Class III.
43 Paragraph 3.3(4)(b) of Schedule 2
Repeal the paragraph, substitute:
(b) specifically to be used in direct contact with the heart, the central circulatory system or the central nervous system of a patient; or
Part 7 -- Amendments relating to charges
Therapeutic Goods (Charges) Regulations 2018
44 Paragraph 7(4)(d)
Omit "Class AIMD medical device or".
45 At the end of the instrument
Add:
Part 3 -- Application and transitional provisions
If, at any time during a charge year, the same medical device is included in the Register as a Class AIMD medical device and a Class III medical device, the charge in respect of the inclusion in the Register of the medical device as a Class III medical device during the charge year is nil.