Therapeutic Goods (Medical Devices) Regulations 2002 (Cth)

Therapeutic Goods (Medical Devices) Regulations 2002

Statutory Rules No. 236, 2002

made under the

Therapeutic Goods Act 1989

Compilation No. 69

Compilation date:1 October 2025

Includes amendments:F2025L01157

About this compilation

This compilation

This is a compilation of the Therapeutic Goods (Medical Devices) Regulations 2002 that shows the text of the law as amended and in force on 1 October 2025 (the compilation date).

The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of provisions of the compiled law.

Uncommenced amendments

The effect of uncommenced amendments is not shown in the text of the compiled law. The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. Any uncommenced amendments affecting the law are accessible on the Register ( saving and transitional provisions

If the operation of a provision or amendment of the compiled law is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes.

Editorial changes

For more information about any editorial changes made in this compilation, see the endnotes.

Presentational changes

The Legislation Act 2003 provides for First Parliamentary Counsel to make presentational changes to a compilation. Presentational changes are applied to give a more consistent look and feel to legislation published on the Register, and enable the user to more easily navigate those documents.

Modifications

If the compiled law is modified by another law, the compiled law operates as modified but the modification does not amend the text of the law. Accordingly, this compilation does not show the text of the compiled law as modified. Any modifications affecting the law are accessible on the Register.

Self‑repealing provisions

If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.

Contents

Part 1Preliminary1.1Name of Regulations

These Regulations are the Therapeutic Goods (Medical Devices) Regulations 2002.

1.3Definitions – the dictionary etc

(1)
The dictionary at the end of these Regulations defines certain words and expressions, and includes, for that purpose, references to certain words and expressions that are defined in the Act or elsewhere in these Regulations (signpost definitions).
Example: The signpost definition ‘medical device—see section 41BD of the Act’ means that the expression medical device is defined in section 41BD of the Therapeutic Goods Act 1989.
Note: The dictionary only includes a signpost definition for a word or expression that is defined elsewhere in these Regulations if the word or expression is used in more than one regulation.
(2)
The dictionary is part of these Regulations.
(3)
A definition in these Regulations applies to each use of the word or expression in these Regulations, unless the contrary intention appears.

1.4Medical devices with a measuring function

(1)
For these Regulations, a medical device has a measuring function if the device is intended by the manufacturer to measure:
(a)
quantitatively a physiological or anatomical parameter; or
(b)
a quantity, or a qualifiable characteristic, of energy or substances delivered to or removed from the human body.
(2)
This regulation does not apply to an IVD medical device.

1.5Refurbishment (Act s 3(1))

(1)
A refurbishment of a medical device is taken to have occurred if the medical device, or a part of the device, is substantially rebuilt from one or more used medical devices of that kind so as to create a medical device that is able to be used for the purpose originally intended by the manufacturer of the original device.
(2)
Without limiting subregulation (1), a refurbishment of a medical device may involve the following actions:
(a)
stripping the device into component parts or sub‑assemblies;
(b)
checking parts of the device for suitability for reuse;
(c)
replacing component parts or sub‑assemblies of the device that are not suitable for reuse;
(d)
assembling reclaimed or replacement component parts or sub‑assemblies of the device or another used device;
(e)
testing a reassembled device against the specifications of the original device or, if the manufacturer has revised those specifications, the revised specifications;
(f)
identifying an assembled device as a refurbished device.

1.6Kinds of medical devices – other common characteristics (Act s 41BE(1)(e))

For paragraph 41BE(1)(e) of the Act, in relation to any of the following medical devices, a characteristic is the unique product identifier of the device:
(a)
a Class 4 IVD medical device, other than an immunohaematology reagent IVD medical device that is a Class 4 IVD medical device;
(c)
a Class III medical device;
(d)
an IVD companion diagnostic.

1.7Device nomenclature system codes (Act s 41BE(3))

(1)
In accordance with the Global Medical Device Nomenclature System Code, as set out in ISO 15225:2000(E), the device nomenclature system code specified for a medical device is:
(a)
for a Class 4 IVD medical device—the relevant preferred term; and
(b)
for a Class 4 IVD medical device that is an immunohaematology reagent IVD medical device—the relevant Level 2 collective term; and
(c)
for a Class 3 IVD medical device—the relevant Level 3 collective term, or if no Level 3 collective term exists, the relevant Level 2 collective term; and
(d)
for a Class 2 IVD medical device—the relevant Level 2 collective term; and
(e)
for a Class 1 IVD medical device or an export only IVD medical device—the relevant Level 1 collective term; and
(f)
for a Class III medical device, Class IIb medical device or Class IIa medical device—the relevant preferred term; and
(g)
for any of the following—the relevant preferred term:
(i)
a Class I medical device that the manufacturer intends to be supplied in a sterile state;
(ii)
a Class I medical device that has a measuring function;
(iii)
a Class I medical device for which there is no relevant template term; and
(h)
for any other Class I medical device—the relevant template term.
(2)
In this regulation:
collective term means a term that:
(a)
is used for those medical devices that share common features; and
(b)
is identified in the Global Medical Device Nomenclature System Code; and
(c)
is included in the document Collective terms available as device nomenclature system codes for IVD medical devices for the purposes of section 41BE(3) of the Act, published by the Therapeutic Goods Administration, as updated from time to time.
Examples:
Examples of the use of a collective term include the following:
(a) to illustrate the scope of certificates issued by conformity assessment bodies when assessing which groups, families or types of medical devices are covered within a manufacturer’s quality system;
(b) to identify the range of skills and general technological abilities for which a conformity assessment body has been approved and is so appointed by the relevant regulatory authority;
(c) for the exchange of information between regulatory authorities when general information on individual manufacturers’ capabilities is notified.
ISO 15225:2000(E) means International Standard ISO 15225:2000(E) (Nomenclature—Specification for a nomenclature system for medical devices for the purposes of regulatory data exchange).
relevant preferred term, for a medical device, means the preferred term for that device under ISO 15225:2000(E).
relevant template term, for a medical device, means the template term for that device under ISO 15225:2000(E).

1.8Classes of persons that are not manufacturers of a medical device

For the purposes of subsection 41BG(4) of the Act, a class of persons is health professionals, or suitably qualified persons within a healthcare facility, who produce a medical device (the final device) where the following are satisfied:
(a)
a medical device production system is used to produce the final device;
(b)
the medical device production system is included in the Register as a kind of medical device.

Part 2Essential principles2.1Essential principles (Act s 41CA)

For section 41CA of the Act, the essential principles for medical devices are set out in Schedule 1.

Part 3Conformity assessment proceduresDivision 3.1Medical device classifications3.1Medical device classifications (Act s 41DB)

(1)
For section 41DB of the Act, the following table specifies the medical device classifications.

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

(2)
In the table:
(a)
the lowest level of medical device classification is specified in column 2; and
(b)
successively higher levels of classification are specified in columns 3 to 5; and
(d)
a device specified in a column has the same level of classification as any other device specified in that column.

3.2Classification of medical devices

(1)
A medical device, other than an IVD medical device, has the medical device classification applying under the classification rules set out in Schedule 2.
(2)
An IVD medical device has the medical device classification applying under the classification rules set out in Schedule 2A.

3.3Principles for applying the classification rules

(1)
For the purpose of classifying a medical device, the principles set out in this regulation apply.
(2)
A medical device is classified as follows:
(a)
if the medical device is a medical device other than an IVD medical device—having regard to the intended purpose of the device;
(b)
if the medical device is an IVD medical device or an in‑house IVD medical device—having regard to the intended purpose of the device in accordance with the following risk classes:
(i)
Class 1 IVD medical device or Class 1 in‑house IVD medical device—no public health risk or low personal risk;
(ii)
Class 2 IVD medical device or Class 2 in‑house IVD medical device—low public health risk or moderate personal risk;
(iii)
Class 3 IVD medical device or Class 3 in‑house IVD medical device—moderate public health risk or high personal risk;
(iv)
Class 4 IVD medical device or Class 4 in‑house IVD medical device—high public health risk.
(3)
If a medical device is designed to be used in combination with another medical device, each of the devices is classified separately.
(4)
An accessory to a medical device is classified separately from the medical device.
(5)
If a medical device is driven, or influenced, by an item of software, the software has the same classification as the medical device.
(5A)
A medical device production system has the same classification as the medical device the system is intended to produce.
(6)
If a medical device is not designed to be used solely or principally in a specific part of a patient’s body, the medical device is classified having regard to the most critical specified use of the medical device.
(7)
If, based on the intended purpose of the device, 2 or more classification rules apply to the medical device, the device has the highest level of classification applying under the applicable classification rules.
(8)
For classification of a medical device system or a medical device procedure pack, medicines are not considered to be integral to the system or the procedure pack.
(9)
For a system or procedure pack that contains both the devices mentioned in subregulation (11), that have different levels of classification under the table in regulation 3.1, the classification level of the system or procedure pack is that of the highest class of device mentioned in subregulation (11).
(10)
A system or procedure pack that contains both of the devices mentioned in subregulation (11), that have the same level of classification under the table in regulation 3.1, is classified according to its primary intended purpose.
(11)
For subregulations (9) and (10), the devices are:
(a)
an IVD medical device; and
(b)
a medical device that is not an IVD medical device.

Division 3.2Conformity assessment procedures3.4Conformity assessment procedures (Act s 41DA)

(1)
For section 41DA of the Act, the requirements relating to the obligations of manufacturers of medical devices (the conformity assessment procedures) are set out in Schedule 3.
(2)
The application of the conformity assessment procedures to a medical device, or a kind of medical device, is set out in this Division.
(3)
Subregulation (4) applies to the following devices:
(a)
Class IIb medical devices;
(b)
Class 3 IVD medical devices;
(c)
Class IIa medical devices;
(d)
Class 2 IVD medical devices;
(e)
Class I medical devices;
(f)
Class 1 IVD medical devices.
(4)
The manufacturer of a device mentioned in subregulation (3) must apply to the device appropriate conformity assessment procedures, being:
(a)
the minimum conformity assessment procedures that are applicable, under this Division, to the device; or
(b)
if the manufacturer prefers, conformity assessment procedures that are applicable, under this Division, to a medical device that is classified at a higher level than the device concerned.

3.5Powers and functions of Secretary in relation to conformity assessment

(1)
For the purpose of applying conformity assessment procedures to a kind of medical device, a power or function of the Secretary, in relation to an assessment to be conducted under the procedures, may be exercised or performed at the place where the manufacturer is located, and at the manufacturing site, by a body or authority that the Secretary is satisfied has the authority and expertise to exercise that power or perform that function.
(2)
If, under the conformity assessment procedures, the manufacturer of the kind of medical device is required to give information of a kind mentioned in paragraph 41MP(2)(a) or (b) of the Act to the Secretary, the information must be given to the Secretary in addition to any such information that is given to the body or authority mentioned in subregulation (1).

3.6Class III medical devices (other than medical devices used for a special purpose)

(1)
Subject to subregulation (2), the conformity assessment procedures that must be applied to a Class III medical device (other than a medical device used for a special purpose) are, as the manufacturer prefers:
(a)
the full quality assurance procedures; or
(b)
the type examination procedures and:
(i)
the verification procedures; or
(ii)
the production quality assurance procedures.
(2)
If the device is intended by the manufacturer to be supplied in a sterile state, the conformity assessment procedures that must be applied to the device are, as the manufacturer prefers:
(a)
the full quality assurance procedures; or
(b)
the type examination procedures and the production quality assurance procedures.

3.6AClass 4 IVD medical devices (other than medical devices to be used for a special purpose)

The conformity assessment procedures that must be applied to a Class 4 IVD medical device (other than a medical device to be used for a special purpose) are, as the manufacturer prefers:
(a)
the full quality assurance procedures; or
(b)
the type examination procedures and the production quality assurance procedures.

3.6BClass 4 in‑house IVD medical devices (other than medical devices to be used for a special purpose)

The conformity assessment procedures that must be applied to a Class 4 in‑house IVD medical device (other than a medical device to be used for a special purpose) are, as the manufacturer prefers:
(a)
the full quality assurance procedures; or
(b)
the conformity assessment procedures set out in Part 6B of Schedule 3.

3.7Class IIb medical devices (other than medical devices used for a special purpose)

(1)
Subject to subregulation (2), the minimum conformity assessment procedures that must be applied to a Class IIb medical device (other than a medical device used for a special purpose) are, as the manufacturer prefers:
(a)
the full quality assurance procedures (other than clause 1.6); or
(b)
the type examination procedures and:
(i)
the verification procedures; or
(ii)
the production quality assurance procedures; or
(iii)
the product quality assurance procedures.
(2)
If the device is intended by the manufacturer to be supplied in a sterile state, the minimum conformity assessment procedures that must be applied to the device are, as the manufacturer prefers:
(a)
the full quality assurance procedures (other than clause 1.6); or
(b)
the type examination procedures and the production quality assurance procedures.
Note: The manufacturer of a Class IIb medical device (other than a medical device used for a special purpose) may prefer to apply to the device the conformity assessment procedures that must be applied to a medical device that is classified at a higher level—see subregulation 3.4(3).

3.7AClass 3 IVD medical devices (other than devices to be used for a special purpose)

The minimum conformity assessment procedures that must be applied to a Class 3 IVD medical device, other than a device to be used for a special purpose, are, as the manufacturer prefers:
(a)
the full quality assurance procedures, other than clause 1.6 of Schedule 3; or
(b)
the type examination procedures and the production quality assurance procedures.
Note: The manufacturer of a Class 3 IVD medical device may prefer to apply to the device the conformity assessment procedures that must be applied to an IVD medical device that is classified at a higher level—see subregulation 3.4(3).

3.7BClass 3 in‑house IVD medical devices

The conformity assessment procedures that must be applied to a Class 3 in‑house IVD medical device are the procedures mentioned in Part 6A of Schedule 3.

3.8Class IIa medical devices (other than medical devices used for a special purpose)

(1)
Subject to subregulation (2), the minimum conformity assessment procedures that must be applied to a Class IIa medical device (other than a medical device used for a special purpose) are, as the manufacturer prefers:
(a)
the full quality assurance procedures (other than clause 1.6); or
(b)
the declaration of conformity (not requiring assessment by Secretary) procedures and:
(i)
the verification procedures (other than clause 3.5); or
(ii)
the production quality assurance procedures (other than clause 4.7); or
(iii)
the product quality assurance procedures (other than clause 5.7).
(2)
If the device is intended by the manufacturer to be supplied in a sterile state, the minimum conformity assessment procedures that must be applied to the device are, as the manufacturer prefers:
(a)
the full quality assurance procedures (other than clause 1.6); or
(b)
the production quality assurance procedures (other than clause 4.7) and the declaration of conformity (not requiring assessment by Secretary) procedures.
Note: The manufacturer of a Class IIa medical device (other than a medical device used for a special purpose) may prefer to apply to the device the conformity assessment procedures that must or may be applied to a medical device that is classified at a higher level—see subregulation 3.4(3).

3.8AClass 2 IVD medical devices (other than devices to be used for a special purpose)

The minimum conformity assessment procedures that must be applied to a Class 2 IVD medical device, other than a device to be used for a special purpose, are, as the manufacturer prefers:
(a)
the full quality assurance procedures, other than clause 1.6 of Schedule 3; or
(b)
the declaration of conformity (not requiring assessment by Secretary) procedures and the production quality assurance procedures, other than clause 4.7 of Schedule 3.
Note: The manufacturer of a Class 2 IVD medical device may prefer to apply to the device the conformity assessment procedures that must be applied to an IVD medical device that is classified at a higher level—see subregulation 3.4(3).

3.8BClass 2 in‑house IVD medical devices

The conformity assessment procedures that must be applied to a Class 2 in‑house IVD medical device are the procedures mentioned in Part 6A of Schedule 3.

3.9Class I medical devices (other than medical devices used for a special purpose)

(1)
Subject to subregulations (2) and (3), the minimum conformity assessment procedures that must be applied to a Class I medical device (other than a medical device used for a special purpose) are the declaration of conformity (not requiring assessment by Secretary) procedures.

(2)
If the device is intended by the manufacturer to be supplied in a sterile state, and the manufacturer applies the declaration of conformity (not requiring assessment by Secretary) procedures to the device, the production quality assurance procedures (other than clause 4.7) must also be applied to the device.
(3)
If the device has a measuring function, and the manufacturer applies the declaration of conformity (not requiring assessment by Secretary) procedures, one of the following sets of procedures, as the manufacturer prefers, must also be applied to the device:
(a)
the verification procedures (other than clause 3.5);
(b)
the production quality assurance procedures (other than clause 4.7);
(c)
the product quality assurance procedures (other than clause 5.7).
Note: The manufacturer of a Class I medical device (other than a medical device used for a special purpose) may prefer to apply to the device the conformity assessment procedures that must be applied to a medical device that is classified at a higher level—see subregulation 3.4(3).

3.9AClass 1 IVD medical devices (other than devices to be used for a special purpose)

The minimum conformity assessment procedures that must be applied to a Class 1 IVD medical device, other than a device to be used for a special purpose, are the declaration of conformity (not requiring assessment by Secretary) procedures.
Note: The manufacturer of a Class 1 IVD medical device may prefer to apply to the device the conformity assessment procedures that must be applied to an IVD medical device that is classified at a higher level—see subregulation 3.4(3).

3.9BClass 1 in‑house IVD medical devices

The conformity assessment procedures that must be applied to a Class 1 in‑house IVD medical device are the procedures mentioned in Part 6A of Schedule 3.

3.10Medical devices used for a special purpose

(1)
This regulation applies to the following kinds of medical devices (medical devices used for a special purpose):
(a)
an exempt device;
(b)
a medical device that is the subject of an approval under section 41HB of the Act;
(c)
a medical device that is the subject of an authority under section 41HC of the Act;
(d)
a system or procedure pack to which subregulation (3) applies.
Note 1: An exempt device is a medical device of a kind that is exempted from the operation of Division 3 of Part 4‑11 of the Act by the regulations (see subsection 3(1) of the Act). Division 7.1 and Schedule 4 to these Regulations deal with exempt devices.
Note 2: For a system or procedure pack to which paragraph (1)(d) applies and that contains an IVD medical device and a medical device that is not an IVD medical device:
(a) the system or procedure pack is classified in accordance with Division 3.1 and either Schedule 2 or Schedule 2A; and
(b) the conformity assessment procedures that must be applied to the system or procedure pack are the procedures for medical devices used for a special purpose in clause 7.5 of Schedule 3.
Note 3: For a system or procedure pack to which paragraph (1)(d) does not apply:
(a) the system or procedure pack is classified in accordance with Division 3.1 and either Schedule 2 or Schedule 2A; and
(b) the conformity assessment procedures that must be applied to the system or procedure pack are the procedures that apply to the relevant classification.
Exception
(1A)
However, paragraphs (1)(a), (b) and (c) do not apply to a Class 1 in‑house IVD medical device, a Class 2 in‑house IVD medical device or a Class 3 in‑house IVD medical device.
Note: The conformity assessment procedures that must be applied to Class 1 in‑house IVD medical devices, Class 2 in‑house IVD medical devices or Class 3 in‑house IVD medical devices are the procedures mentioned in Part 6A of Schedule 3.
(2)
The conformity assessment procedures that must be applied to a medical device used for a special purpose are the procedures for medical devices used for a special purpose.
(3)
This subregulation applies to a system or procedure pack:
(a)
where each medical device included in the system or procedure pack is a medical device to which the relevant conformity assessment procedures have been applied; and
(aa)
if one or more medicines, biologicals or other therapeutic goods are included in the system or procedure pack:
(i)
if all of those medicines and biologicals are entered on the Register; and
(ii)
if all of those other therapeutic goods are entered on the Register, or are covered by subregulation 12(1) of the Therapeutic Goods Regulations 1990 to the extent that they are tampons, menstrual cups or disinfectants; and
(iii)
if there has been no modification of the packaging of any of those medicines, biologicals or other therapeutic goods; and
(iv)
if there has been no modification of any of those medicines, biologicals or other therapeutic goods; and

(b)
that has been put together in accordance with the intended purpose of each medical device and the approved indications of each medicine, biological and other therapeutic goods; and
(c)
the contents of which are compatible, having regard to the intended purpose of each medical device, the approved indications of each medicine, biological or other therapeutic goods, and the intended purpose of the system or procedure pack.
(4)
If a system or procedure pack is intended by the manufacturer to be supplied in a sterile state:
(a)
the full quality assurance procedures (other than clause 1.6); or
(b)
the production quality assurance procedures (other than clause 4.7);
must also be applied to the system or procedure pack in relation to the aspects of the manufacturing process that relate to ensuring that the system or procedure pack is supplied and maintained in a sterile state.
Note: If a medicine is included in the system or procedure pack, the manufacturer of the system or procedure pack must ensure that the method to be used for sterilisation or resterilisation is appropriate or is in accordance with the approved indications of the medicine.

3.11Medical devices to which the clinical evaluation procedures must be applied

(1)
Subject to subregulation (2), in addition to the conformity assessment procedures that are applied to a medical device in accordance with another regulation in this Division, the clinical evaluation procedures must also be applied to the device, for the purpose of demonstrating that the device complies with the applicable provisions of the essential principles, in particular:
(a)
clause 1 of Schedule 1 (identification of the benefits and risks associated with the use of the device); and
(b)
clause 3 of Schedule 1 (use of the device for its intended purpose); and
(c)
clause 6 of Schedule 1 (acceptability of any side effects associated with the use of the device).
(2)
This regulation does not apply to any of the following:
(a)
an exempt device (other than an exempt device of a kind described in item 1.3 of Schedule 4);
(b)
a medical device that is the subject of an approval under section 41HB of the Act;
(c)
a medical device that is the subject of an authority under section 41HC of the Act.
(3)
Despite subregulation (2), this regulation applies to a custom‑made medical device.

3.12Records to be provided in English

All records (including correspondence) provided by the manufacturer of a medical device in relation to the application of the conformity assessment procedures to the device must be in English.

3.13Assessment or verification at intermediate stage of manufacture

(1)
At the request of a person, and on payment of the prescribed fee, the Secretary may arrange for assessment or verification procedures to be carried out in relation to the application of the conformity assessment procedures to an article that is intended to be used in the manufacture of a medical device.
(2)
A request may be made:
(a)
at any stage of the manufacturing process; and
(b)
whether or not an application has been made in relation to the article:
(i)
for a conformity assessment certificate in respect of a medical device; or
(ii)
for inclusion of a kind of medical device in the Register.

Part 4Conformity assessment certificatesDivision 4.1Issuing conformity assessment certificates4.2Considering applications for conformity assessment certificates (Act s 41EC)

For subsection 41EC(2) of the Act, the following other requirements of the conformity assessment procedures are specified:
(a)
the applicable requirements in relation to the establishment and maintenance of a post‑market monitoring, reporting and corrective action system;
(b)
the applicable requirements in relation to the keeping of records.

4.3Time for making decision on applications (Act s 41ED, s 63(2)(dc))

(1)
This regulation applies to an application for the issue of a conformity assessment certificate in respect of a kind of medical device if, in considering the application, the Secretary is required to examine the design of the device.
(2)
The Secretary must make a decision on the application within 255 working days after the application is received at an office of the Department specified by the Secretary.
(3)
For subregulation (2), a working day that occurs in any of the following periods is to be disregarded:
(a)
if the Secretary sends a query, or a request for information, to the applicant or sponsor—the period beginning on the day when the query or request is sent and ending at the end of the day when the Secretary receives from the applicant or sponsor a response that enables the Secretary to proceed with the assessment;
(b)
if an appeal is lodged in relation to the application—the period beginning on the day when the appeal is lodged and ending at the end of the day when the appeal is finally determined;
(c)
any other period in relation to which the applicant or sponsor agrees in writing for the purposes of this subregulation.

Division 4.1AConformity assessment (priority applicant) determinations4.3AApplication of Division

For the purposes of subsection 41ECA(1) of the Act, this Subdivision makes provision for and in relation to the making of conformity assessment (priority applicant) determinations.

4.3BApplication for conformity assessment (priority applicant) determination

(1)
A person may apply to the Secretary for a conformity assessment (priority applicant) determination in relation to a medical device.
(2)
An application under subregulation (1) must:
(a)
be in writing; and
(b)
be in a form approved, in writing, by the Secretary; and
(c)
have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.
(3)
An application under subregulation (1) is taken not to have been made unless:
(a)
the application meets the requirements in subregulation (2); and
(b)
the fee prescribed in item 1.1A of Part 1 of Schedule 5 for making the application has been paid.

4.3CMaking of conformity assessment (priority applicant) determination

(1)
On receiving an application under subregulation 4.3B(1) for a conformity assessment (priority applicant) determination in relation to a medical device, the Secretary must:
(a)
consider the application; and
(b)
decide either:
(i)
to make the determination; or
(ii)
to refuse to make the determination.
Criteria
(2)
The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medical device (the new device):
(a)
the intended purpose of the new device is the monitoring, treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;
(b)either:
(i) no medical devices with that intended purpose are of a kind included in the Register; or
(ii)
if one or more medical devices with that intended purpose are of a kind included in the Register (the existing devices)—there is substantial evidence demonstrating that the safety or performance of the new device when used for that intended purpose provides a significant improvement compared to the existing devices;
(c)
at least one of the following applies to the new device:
(i)
the new device is a breakthrough technology and there is evidence that it offers a major clinical advantage over existing technology;
(ii)
there is evidence that the new device offers a major clinical advantage over existing alternatives included in the Register;
(iii)
the new device is an IVD medical device and its early availability in Australia will result in a major public health benefit.
Information to be specified in determination
(3)
The determination must specify:
(a)
the person who, as a result of section 41ECA of the Act, is the priority applicant; and
(b)
the medical device to which the determination relates; and
(c)
the intended purpose of the medical device.
Notification of decision
(4)
As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.
(5)
If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.

4.3DPeriod during which conformity assessment (priority applicant) determination is in force

(1)
A conformity assessment (priority applicant) determination in relation to a medical device:
(a)
comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 4.3C(4); and
(b)
subject to subregulation (2) and regulation 4.3E, remains in force for 6 months.
(2)
If the priority applicant specified in the determination makes an effective application under section 41EB of the Act for a conformity assessment certificate that covers the medical device before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:
(a)
the priority applicant withdraws the application; or
(b)
the application lapses in accordance with section 41EG of the Act; or
(c)
the application is finally determined.
Note: See subsection 41EB(2) of the Act for when an application under section 41EB of the Act is effective.

4.3ERevocation of conformity assessment (priority applicant) determination

(1)
The Secretary may revoke a conformity assessment (priority applicant) determination in relation to a medical device if:
(a)
either:
(i)
the priority applicant specified in the determination has not made an application under section 41EB of the Act for a conformity assessment certificate that covers the medical device; or
(ii)
the priority applicant has made such an application, but the application is not effective; and
(b)
the Secretary is satisfied that the criteria specified in subregulation 4.3C(2) are no longer satisfied in relation to the medical device.
Note: See subsection 41EB(2) of the Act for when an application under section 41EB of the Act is effective.
(2)
The revocation must be by written notice given by the Secretary to the priority applicant.

Division 4.1BContent of conformity assessment certificates4.3FContent of conformity assessment certificates

For the purposes of subsection 41EE(3) of the Act, the information is all of the following:
(a)
a unique identification number for the certificate;
(b)
the day on which the certificate is issued;
(c)
the name and address of the manufacturer of the medical devices;
(d)
the conformity assessment procedures applied to the medical devices by the manufacturer;
(e)
if the certificate covers a medical device to which paragraph 1.6(a), (b), (c) or (d) applies—the unique product identifier of the device;
(f)
the conditions to which the certificate is subject under section 41EJ or 41EK of the Act;
(g)
if one or more conformity assessment certificates have previously been issued in respect of the medical devices—the day on which each of those certificates was issued;
(h)
the signature and name of the person issuing the certificate.

Division 4.1CConditions4.3GConditions applying automatically – information about poisons

(1)
This regulation applies to a conformity assessment certificate that covers a kind of medical device that contains a substance of a kind covered by an entry in a Schedule to the current Poisons Standard.
(2)
However, this regulation does not apply to the certificate if, under Appendix A to the current Poisons Standard, the Standard does not apply to poisons in that kind of device.
(3)
For the purposes of subsection 41EJ(5A) of the Act, the certificate is subject to the condition that the manufacturer in respect of whom the certificate is issued will not supply a medical device of that kind if the supply would contravene Part 2 of the current Poisons Standard.

Division 4.2Suspension of conformity assessment certificates4.4Period for revocation of suspension (Act s 41EP, s 63(2)(db))

(1)
This regulation applies to an application to the Secretary under paragraph 41EP(2)(a) of the Act to revoke the suspension of a conformity assessment certificate.
(2)
The Secretary must make a decision on the application within 40 working days after the application is received at an office of the Department specified by the Secretary.

Division 4.3Transfer of conformity assessment certificates4.5Application of Division 4.3

This Division applies in relation to a manufacturer of a medical device in respect of whom a conformity assessment certificate is issued.

4.6Death, bankruptcy or winding up of manufacturer

(1)
If the manufacturer dies, the manufacturer’s legal personal representative:
(a)
is taken to be the person in respect of whom the conformity assessment certificate is issued; and
(b)
must notify the Secretary, in writing, of the death not later than 3 months after it occurred.
(2)
If the manufacturer becomes bankrupt, the trustee in bankruptcy of the manufacturer’s estate:
(a)
is taken to be the person in respect of whom the conformity assessment certificate is issued; and
(b)
must notify the Secretary, in writing, of the manufacturer’s bankruptcy not later than 3 months after it occurred.
(3)
If the manufacturer is a body corporate that is wound up, the liquidator of the body corporate:
(a)
is taken to be the person in respect of whom the conformity assessment certificate is issued; and
(b)
must notify the Secretary, in writing, of the winding up of the body corporate not later than 3 months after it occurred.
Note: See also regulations 4.10 and 4.11.

4.7Disposal of business or amalgamation with another manufacturer

(1)
This regulation applies if the name of the manufacturer is changed in any of the following circumstances:
(a)
the manufacturer agrees to dispose of a business concerned with the manufacture of the medical device, and it is agreed that the disposal is to include a transfer of the conformity assessment certificate issued in respect of the manufacturer and the medical device;
(b)
in the case of a manufacturer that is a body corporate—the manufacturer amalgamates with another body corporate under a name that is different from the name of the manufacturer on the conformity assessment certificate.
(2)
The person to whom the business is disposed of, or the body corporate with whom the manufacturer amalgamates:
(a)
is taken to be the person in respect of whom the conformity assessment certificate is issued; and
(b)
must, not later than 3 months after the disposal or amalgamation, apply to the Secretary, in writing, for the name of the manufacturer to be changed on the conformity assessment certificate.

4.8Change of name of manufacturer

If the name of the manufacturer is changed:
(a)
the manufacturer, as renamed, is taken to be the person in respect of whom the conformity assessment certificate is issued; and
(b)
the manufacturer must, not later than 3 months after the name is changed, notify the Secretary, in writing, of the new name and the circumstances in which the change occurred.
Note: See also regulations 4.10 and 4.11.

4.9Effect of conformity assessment certificate after transfer, etc

If a conformity assessment certificate is taken to be issued in respect of a person because of the operation of regulation 4.6, 4.7 or 4.8:
(a)
the certificate has effect as if it had actually been issued in respect of that person; and
(b)
the medical devices to which the certificate relates may continue to be manufactured while the certificate is in effect.

4.10Notification to Secretary of events

(1)
If a person is required to notify the Secretary of an event under this Division, the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.
(2)
If, at any time, the Secretary becomes aware that he or she has not been notified of an event as required by this Division, the Secretary may suspend or revoke the conformity assessment certificate to which the event relates.

4.11Notification of change of name or suspension or revocation of conformity assessment certificate

(1)
If, under this Division, the Secretary:
(a)
changes the name of a manufacturer on a conformity assessment certificate; or
(b)
suspends or revokes a conformity assessment certificate issued in respect of a manufacturer;
the Secretary must, as soon as practicable after changing the name or suspending or revoking the conformity assessment certificate:
(c)
notify the manufacturer that the name has been changed or the conformity assessment certificate has been suspended or revoked; and
(d)
ask the manufacturer to return to the Secretary the conformity assessment certificate that was given before the change of name or suspension or revocation.
(2)
If a manufacturer receives a notice under subregulation (1), the manufacturer must return to the Secretary, as soon as practicable after receiving the notice, the conformity assessment certificate that was given before the change of name or suspension or revocation.
Penalty: 5 penalty units.
(3)
An offence against subregulation (2) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.

Part 4AAustralian conformity assessment bodiesDivision 4A.1Preliminary4A.1Purposes of this Part

(1)
This Part (other than Division 4A.7) is made for the purposes of section 41EWA of the Act (about Australian conformity assessment bodies).
(2)
Division 4A.7 is made for the purposes of section 41EWB of the Act (about the content of Australian conformity assessment body certificates).

Division 4A.2Making conformity assessment body determinations4A.2Applications

(1)
An Australian corporation may apply to the Secretary for a conformity assessment body determination in respect of the corporation.
(2)
The application must:
(a)
be made:
(i)
in writing; and
(ii)
in a form (if any) approved under subregulation (4); and
(iii)
in a manner (if any) approved under subregulation (4); and
(b)
be delivered to an office of the Department specified under subregulation (6).
(3)
The application is not effective if:
(a)
the application does not meet the requirements of subregulation (2) and regulation 4A.4; or
(b)
the application contains information that is false or misleading in a material particular; or
(c)
the application fee for the application has not been paid.
Note 1: For the application fee, see regulation 9.1 and Part 1 of Schedule 5.
Note 2: A conformity assessment body determination assessment fee is payable under Division 9.2 for assessment of the application.
Forms and manners
(4)
For the purposes of subparagraph (2)(a)(ii) or (iii), the Secretary may, in writing, approve a form or manner for making an application for a conformity assessment body determination.
(5)
The Secretary may approve different forms and manners for different classes of conformity assessment body determinations.
Offices
(6)
For the purposes of paragraph (2)(b), the Secretary may, in writing, specify an office of the Department to which applications for conformity assessment bodies must be delivered.
(7)
The Secretary may specify different offices for different classes of conformity assessment body determinations.

4A.3Further information

(1)
For the purposes of assessing an application for a conformity assessment body determination, the Secretary may, by written notice given to the applicant, require the applicant to deliver specified information or documents:
(a)
to the office of the Department to which the application was delivered; and
(b)
within the period, of not less than 10 working days after the day the notice is given, specified in the notice; and
(c)
in a manner (if any) specified in the notice; and
(d)
in accordance with regulation 4A.4.
(2)
For the purposes of assessing an application for a conformity assessment body determination, the Secretary may:
(a)
by written notice given to the applicant, require the applicant to allow an authorised person, at any reasonable time specified in the notice, to inspect specified premises (including premises outside Australia) that are or will be used by the applicant to carry on certification‑related activities; or
(b)
by written notice given to a contractor of the applicant, require the contractor to allow an authorised person, at any reasonable time specified in the notice, to inspect specified premises (including premises outside Australia) that are or will be used by the contractor to carry on certification‑related activities for the applicant.
Note: For authorised person, see subsection 3(1) of the Act.
(3)
If the Secretary gives a notice to a contractor under paragraph (2)(b), the Secretary must give a copy of the notice to the applicant.

4A.4Documents to be provided in English

All documents (including correspondence) provided by an applicant in relation to an application for a conformity assessment body determination:
(a)
must be provided in English; and
(b)
may also be provided in any other language.

4A.5Lapsing of applications

An application for a conformity assessment body determination lapses if:
(a)
the applicant, or a contractor of the applicant, fails to comply with a notice under subregulation 4A.3(1) or (2) in relation to the application; or
(b)
information given to the Secretary by, or on behalf of, the applicant in connection with the application, including information given for the purposes of a notice under subregulation 4A.3(1), is false or misleading in a material particular; or
(c)
for the whole or a part of the conformity assessment body determination assessment fee for the application that is due and payable as mentioned in Division 9.2—the applicant fails to pay that whole or part in accordance with that Division.

4A.6Assessing applications

(1)
If an application is made in accordance with regulation 4A.2 for a conformity assessment body determination in respect of an Australian corporation, the Secretary must decide whether to make the conformity assessment body determination.
Conditions and criteria for making determinations
(2)
The Secretary must not decide to make the determination unless he or she is satisfied that it is likely that the Australian corporation will be able to comply with the requirements of Schedule 3AA.
(3)
In deciding whether to make the conformity assessment body determination, the Secretary must also consider:
(a)
whether at least one of the following persons:
(i)
the Australian corporation;
(ii)
a person (a manager) who makes, or participates in making, decisions that affect the whole, or a substantial part, of the Australian corporation’s affairs;
(iii)
a major interest holder of the Australian corporation;
has, within the 10 years immediately before the application:
(iv)
been convicted of an offence against the Act or a corresponding State law; or
(v)
been convicted of an offence against a law of the Commonwealth or a law of a State or Territory involving fraud or dishonesty; or
(vi)
been ordered to pay a pecuniary penalty for the contravention of a civil penalty provision of the Act or a corresponding State law; or
(vii)
been ordered to pay a pecuniary penalty for the contravention of a civil penalty provision of a law of the Commonwealth or a law of a State or Territory involving fraud or dishonesty; or
(viii)
breached a condition of a conformity assessment body determination; or
(ix)
had a conformity assessment body determination in respect of the person suspended or revoked; or
(x)
been a manager, or a major interest holder, of a body corporate in respect of which subparagraph (iv), (v), (vi), (vii), (viii) or (ix) applies in that 10 years, if the conduct resulting in that subparagraph applying occurred when the person was a manager or major interest holder of the body corporate; and
(b)
any other relevant matter.
(4)
A reference in paragraph (3)(a) to a person convicted of an offence includes a reference to a person in respect of whom an order has been made relating to the offence under:
(a)
section 19B of the Crimes Act 1914; or
(b)
a corresponding provision of a law of a State or Territory.
Note: Section 19B of the Crimes Act 1914 empowers a court that has found a person to have committed an offence to take action without proceeding to record a conviction.
(5)
Nothing in this regulation affects the operation of Part VIIC of the Crimes Act 1914 (which includes provisions that, in certain circumstances, relieve persons from the requirement to disclose spent convictions and require persons aware of such convictions to disregard them).
(6)
Subregulation (2) and paragraph (3)(a) do not limit paragraph (3)(b).

4A.7Procedure following decisions to make determinations

(1)
This regulation applies if the Secretary decides under subregulation 4A.6(1) to make a conformity assessment body determination in respect of an Australian corporation.
(2)
The Secretary must notify the Australian corporation within 20 working days.
(3)
When all conformity assessment body determination assessment fees that are due and payable for the application have been paid, the Secretary must:
(a)
make the determination, including specifying:
(i)
the scope of the determination in accordance with subregulation (4); and
(ii)
the commencement and duration of the determination in accordance with regulation 4A.8; and
(b)
give it to the corporation.
(4)
The conformity assessment body determination must specify whether it:
(a)
is of general application; or
(b)
is limited to either or both of the following:
(i)
one or more specified medical devices;
(ii)
one or more specified conformity assessment procedures.
(5)
The conformity assessment body determination may specify conditions to which it is subject.
Note: See regulation 4A.19.

4A.8Duration of determinations

(1)
A conformity assessment body determination commences on the day specified for the purpose in the determination under subparagraph 4A.7(3)(a)(ii).
(2)
A conformity assessment body determination has effect at all times:
(a)
unless the determination is suspended under Division 4A.4; or
(b)
until the end of the period specified in the determination under subparagraph 4A.7(3)(a)(ii); or
(c)
until the determination is revoked under Division 4A.5.
(3)
The period specified in the determination as mentioned in paragraph (2)(b) must be 5 years or less, starting on the day the determination commences.

4A.9Procedure following decisions not to make determinations

(1)
This regulation applies if the Secretary decides under subregulation 4A.6(1) not to make a conformity assessment body determination in respect of an Australian corporation.
(2)
The Secretary must notify the Australian corporation within 20 working days.
(3)
The notice must state the reasons for the decision.

Division 4A.3Conditions on conformity assessment body determinationsSubdivision AAutomatic conditions on determinations4A.10Automatic conditions on determinations

A conformity assessment body determination is subject to the conditions set out in this Subdivision.
Note: See sections 41MN and 41MNA of the Act for offences and civil penalty provisions that apply to breaching a condition of a conformity assessment body determination.

4A.11Conditions – requirements of Schedule 3AA

The Australian conformity assessment body will comply with the requirements of Schedule 3AA.

4A.12Conditions – notifying Secretary and clients

(1)
The Australian conformity assessment body will notify the Secretary within 10 working days if there are any substantial changes relating to the body’s compliance with the requirements of Schedule 3AA.
(2)
The Australian conformity assessment body will notify the Secretary and relevant clients of the body as soon as practicable if the body plans to cease carrying on one or more kinds of certification‑related activities relating to conformity assessment procedures covered by the determination.
(3)
The notice under subregulation (2) must specify the day on which the body plans to cease carrying on the activity.

4A.13Conditions – entry and inspection

(1)
The Australian conformity assessment body will allow an authorised person:
(a)
to enter, at any reasonable time, premises used by the body to carry on certification‑related activities; and
(b)
while on those premises, to inspect those premises and anything on those premises that concerns certification‑related activities carried on by the body; and
(c)
while on those premises, to make any still or moving image or any recording of those premises or anything on those premises that concerns certification‑related activities carried on by the body; and
(d)
while on those premises, to inspect, and make copies of, any documents that concern certification‑related activities carried on by the body.
(2)
The Australian conformity assessment body will have procedures, including a written agreement, in place with each contractor of the body that carries on certification‑related activities for the body that require the contractor to allow an authorised person:
(a)
to enter, at any reasonable time, premises used by the contractor to carry on those certification‑related activities; and
(b)
while on those premises, to inspect those premises and anything on those premises that concerns those certification‑related activities; and
(c)
while on those premises, to make any still or moving image or any recording of those premises or anything on those premises that concerns those certification‑related activities; and
(d)
while on those premises, to inspect, and make copies of, any documents that concern those certification‑related activities.

4A.14Conditions – producing information and documents

(1)
The Australian conformity assessment body will, if requested to do so by the Secretary, give the Secretary information, or produce to the Secretary documents, that concern certification‑related activities carried on by the body.
(2)
The information will be given, or the documents produced, within the period, of not less than 20 working days after the day the notice is given, specified in the notice.
(3)
The Australian conformity assessment body will have procedures, including a written agreement, in place with each of:
(a)
its clients; and
(b)
the contractors of the body that carry on certification‑related activities for the body;
that require the client or contractor to make available information or documents that the client or contractor has that is requested under subregulation (1).

4A.15Conditions – reviews

The Australian conformity assessment body will cooperate in any review by the Secretary of:
(a)
certification‑related activities carried on by the body; or
(b)
compliance with the conditions of the conformity assessment body determination.

4A.16Conditions – record keeping

The Australian conformity assessment body will keep:
(a)
the records required by Schedule 3AA; and
(b)
any other records necessary to demonstrate the body’s compliance, at all times while the determination is in effect, with the requirements of that Schedule.

4A.17Conditions – Australian conformity assessment body certificates

Conformity assessment procedures
(1)
The Australian conformity assessment body will not issue an Australian conformity assessment body certificate unless the body is satisfied that an appropriate conformity assessment procedure has been applied to medical devices of the kind covered by the certificate.
Varying, suspending and revoking certificates
(2)
If the Australian conformity assessment body:
(a)
issues an Australian conformity assessment body certificate to a manufacturer; and
(b)
ceases to be satisfied that an appropriate conformity assessment procedure has been applied to medical devices of the kind covered by the certificate;
the body will:
(c)
vary, suspend or revoke the certificate; or
(d)
give to the manufacturer a written notice stating that the body will vary, suspend or revoke the certificate if the manufacturer does not, within a specified period, take the action necessary to satisfy the body that an appropriate conformity assessment procedure has been applied to the devices.
(3)
A period specified in a notice under paragraph (2)(d) must be appropriate.
(4)
The Australian conformity assessment body will vary, suspend or revoke an Australian conformity assessment body certificate if:
(a)
the body gave a notice to a manufacturer under paragraph (2)(d) in relation to the certificate; and
(b)
at the end of the period specified in the notice, the body is not satisfied that an appropriate conformity assessment procedure has been applied to medical devices of the kind covered by the certificate.
Notifying Secretary of changes to certificates and other matters
(5)
The Australian conformity assessment body will notify the Secretary within 10 working days if the body:
(a)
decides not to issue an Australian conformity assessment body certificate because the body is not satisfied as mentioned in subregulation (1); or
(b)
suspends or revokes an Australian conformity assessment body certificate; or
(c)
varies an Australian conformity assessment body certificate in the circumstances mentioned in subregulation (2) or (4); or
(d)
becomes aware of a matter of significant concern relating to the safety of a medical device to which an Australian conformity assessment body certificate issued by the body applies.

4A.18Conditions – clients

Notifying clients if determination varied or suspended
(1)
The Australian conformity assessment body will notify its clients within 10 working days if the conformity assessment body determination is varied or suspended.
Agreements with successor Australian conformity assessment bodies
(2)
If a client of the Australian conformity assessment body (the old body) informs the old body that the client plans:
(a)
to cease to be a client of the old body; and
(b)
to become a client of another Australian conformity assessment body (the new body);
the old body will enter into an agreement with the new body that deals appropriately with the transfer from the old body to the new body of responsibility for carrying on certification‑related activities for the client.
Enquiries before accepting applications for certification
(3)
Before the Australian conformity assessment body accepts an application from a manufacturer to issue an Australian conformity assessment body certificate in relation to a kind of medical device, the body will make reasonable enquiries as to whether the manufacturer has applied to another Australian conformity assessment body to issue an Australian conformity assessment body certificate in relation to that kind of device.

Subdivision BConditions specified in conformity assessment body determinations4A.19Conditions specified in determinations

(1)
A conformity assessment body determination is subject to any conditions specified in the determination under subregulation 4A.7(5) or 4A.28(1).
Note: See sections 41MN and 41MNA of the Act for offences and civil penalty provisions that apply to breaching a condition of a conformity assessment body determination.
(2)
A condition imposed under subregulation 4A.7(5) or 4A.28(1) is in addition to the conditions imposed under Subdivision A of this Division.

Division 4A.4Suspension of conformity assessment body determinations4A.20Suspension of determinations

(1)
The Secretary may, by written notice given to an Australian conformity assessment body, suspend the body’s conformity assessment body determination if the Secretary is satisfied that:
(a)
it is likely that there are grounds for revoking the determination under regulation 4A.27; and
(b)
it is likely that the body will, within the period of the suspension, be able to take action such that it will no longer be likely that there are grounds for revoking the determination.
(2)
The notice must specify the period of the suspension. The period:
(a)
must not exceed 12 months; and

(b)
must not begin before the notice is given to the body.
Note: The period of the suspension may be extended once under regulation 4A.22.

4A.21Notice of proposed suspension

(1)
However, before suspending a conformity assessment body determination, the Secretary must:
(a)
notify the Australian conformity assessment body in writing that the Secretary proposes the suspension and set out the reasons for it; and
(b)
give the body a reasonable opportunity to make submissions to the Secretary in relation to the proposed suspension.
(2)
The Secretary must not make a decision relating to the proposed suspension until the Secretary has had regard to any submissions the body makes under paragraph (1)(b).

4A.22Duration of suspension

(1)
The suspension takes effect on the day specified for the purpose in the notice, which must be at least 20 working days after the notice is given to the Australian conformity assessment body.
(2)
The suspension has effect until:
(a)
the Secretary revokes it under regulation 4A.23; or
(b)
the end of:
(i)
the period specified in the notice under subregulation 4A.20(2); or
(ii)
if the period is extended under subregulation (3) of this regulation—the period as so extended.
Note 1: The conditions to which the determination is subject continue during the suspension: see subsection 41EWA(7A) of the Act.
Note 2: Unless a suspension of a conformity assessment body determination has been revoked, the determination is automatically revoked at the end of the period of the suspension: see regulation 4A.25.
(3)
The Secretary may, by written notice given to the body, extend the period specified in the notice under subregulation 4A.20(2) by a further specified period not exceeding 12 months if the Australian conformity assessment body shows that it has taken steps to address the grounds for revoking the determination under regulation 4A.27.
(4)
Only one extension of the period of the suspension may be made.

4A.23Revocation of suspension

(1)
The Secretary must revoke the suspension if the Secretary is satisfied that:
(a)
the grounds on which the conformity assessment body determination was suspended no longer apply; and
(b)
there are no other grounds for suspending the determination.
(2)
The Secretary’s power to revoke the suspension may be exercised:
(a)
if the Australian conformity assessment body applies in writing to the Secretary; or
(b)
on the Secretary’s own initiative.
(3)
After revoking the suspension, the Secretary must, within 20 working days after the revocation, give written notice of the revocation to the Australian conformity assessment body.
(4)
If the Secretary decides, after an application is made under paragraph (2)(a), not to revoke the suspension, the Secretary must:
(a)
notify the applicant in writing of his or her decision within 20 working days after the decision is made; and
(b)
state in the notice the reasons for the decision.

4A.24Powers of revocation of determinations unaffected

(1)
This Division does not affect the Secretary’s powers to revoke a conformity assessment body determination under Division 4A.5.
(2)
To the extent that a suspension under this Division relates to a conformity assessment body determination to which such a revocation relates, the suspension ceases to have effect.

Division 4A.5Revocation of conformity assessment body determinations4A.25Automatic revocation of determinations

(1)
The Secretary must, by written notice given to an Australian conformity assessment body, revoke the body’s conformity assessment body determination if:
(a)
the determination has been suspended under Division 4A.4; and
(b)
the period of the suspension under paragraph 4A.22(2)(b) ends before the suspension is revoked under regulation 4A.23.
(2)
The revocation takes effect at the end of the period mentioned in paragraph (1)(b) of this regulation.

4A.26Immediate revocation of determinations

(1)
The Secretary may, by written notice given to an Australian conformity assessment body, revoke the body’s conformity assessment body determination if:
(a)
the body applies in writing to the Secretary; or
(b)
the body notifies the Secretary, as mentioned in subregulation 4A.12(2), that the body plans to cease carrying on certification‑related activities completely.
(2)
The revocation takes effect on the day specified for the purpose in the notice given by the Secretary.
(3)
If paragraph (1)(b) applies, the day specified in the notice given by the Secretary must be the day the Australian conformity assessment body notified the Secretary was the day the body planned to cease carrying on certification‑related activities.

4A.27Revocation of determinations after notice of proposed revocation

(1)
The Secretary may, by written notice given to an Australian conformity assessment body, revoke the body’s conformity assessment body determination if:
(a)
the body refuses or fails to comply with a condition to which the determination is subject; or
(b)
at least one of the following persons:
(i)
the body;
(ii)
a person (a manager) who makes, or participates in making, decisions that affect the whole, or a substantial part, of the body’s affairs;
(iii)
a major interest holder of the body;
has:
(iv)
been convicted of an offence against the Act or a corresponding State law; or
(v)
been convicted of an offence against a law of the Commonwealth or a law of a State or Territory involving fraud or dishonesty; or
(vi)
been ordered to pay a pecuniary penalty for the contravention of a civil penalty provision of the Act or a corresponding State law; or
(vii)
been ordered to pay a pecuniary penalty for the contravention of a civil penalty provision of a law of the Commonwealth or a law of a State or Territory involving fraud or dishonesty; or
(viii)
breached a condition of a conformity assessment body determination; or
(ix)
had a conformity assessment body determination in respect of the person suspended or revoked; or
(x)
been a manager, or a major interest holder, of a body corporate in respect of which subparagraph (iv), (v), (vi), (vii), (viii) or (ix) applies, if the conduct resulting in that subparagraph applying occurred when the person was a manager or major interest holder of the body corporate.
(2)
A reference in paragraph (1)(b) to a person convicted of an offence includes a reference to a person in respect of whom an order has been made relating to the offence under:
(a)
section 19B of the Crimes Act 1914; or
(b)
a corresponding provision of a law of a State or Territory.
Note: Section 19B of the Crimes Act 1914 empowers a court that has found a person to have committed an offence to take action without proceeding to record a conviction.
(3)
Nothing in this regulation affects the operation of Part VIIC of the Crimes Act 1914 (which includes provisions that, in certain circumstances, relieve persons from the requirement to disclose spent convictions and require persons aware of such convictions to disregard them).
Notice of proposed revocation
(4)
Before revoking a conformity assessment body determination under this regulation, the Secretary must:
(a)
notify the Australian conformity assessment body in writing that the Secretary proposes the revocation and set out the reasons for it; and
(b)
give the body a reasonable opportunity to make submissions to the Secretary in relation to the proposed revocation.
(5)
The Secretary must not make a decision relating to the proposed revocation until the Secretary has had regard to any submissions the body makes under paragraph (4)(b).
When revocation takes effect
(6)
A revocation under this regulation takes effect on the day specified for the purpose in the notice given to the Australian conformity assessment body under subregulation (1).
(7)
The day specified must not be earlier than the day the notice is given to the body.

Division 4A.6Variation of conformity assessment body determinations4A.28Imposing, varying or removing conditions

(1)
The Secretary may, by written notice given to an Australian conformity assessment body, vary the body’s conformity assessment body determination to:
(a)
impose new conditions on the determination; or
(b)
vary or remove existing conditions imposed on the determination under subregulation 4A.7(5) or this regulation.
(2)
The Secretary’s power under subregulation (1) may be exercised:
(a)
if the Australian conformity assessment body applies in writing to the Secretary; or
(b)
on the Secretary’s own initiative.
When imposition, variation or removal takes effect
(3)
An imposition or variation of a condition under this regulation takes effect on the day specified for the purpose in the notice.
(4)
The day specified in the notice under subregulation (3) must be at least 20 working days after the notice is given to the body, unless the body:
(a)
applied for the imposition or variation; and
(b)
has agreed to an earlier day.
(5)
A removal of a condition under this regulation takes effect on the day specified in the notice.
(6)
The day specified in the notice under subregulation (5) must be at least 20 working days after the notice is given to the body, unless the body has agreed to an earlier day.
(7)
For the purposes of subregulations (4) and (6), the earlier day must not be earlier than the day the notice is given to the body.

4A.29Limiting determinations

(1)
The Secretary may, by written notice given to an Australian conformity assessment body, vary the body’s conformity assessment body determination to limit, or further limit, the determination as mentioned in paragraph 4A.7(4)(b).
(2)
The Secretary’s power under subregulation (1) of this regulation may be exercised:
(a)
if the Australian conformity assessment body applies in writing to the Secretary; or
(b)
on the Secretary’s own initiative.
(3)
A variation under this regulation takes effect on the day specified for the purpose in the notice.
(4)
The day specified in the notice under subregulation (3) must be at least 20 working days after the notice is given to the body, unless the body:
(a)
applied for the variation; and
(b)
has agreed to an earlier day.
(5)
For the purposes of subregulation (4), the earlier day must not be earlier than the day the notice is given to the body.

4A.30Notice of proposed variation

(1)
Before varying a conformity assessment body determination under this Division, the Secretary must:
(a)
notify the Australian conformity assessment body in writing that the Secretary proposes the variation and set out the reasons for it; and
(b)
give the body a reasonable opportunity to make submissions to the Secretary in relation to the proposed variation.
(2)
The Secretary must not make a decision relating to the proposed variation until the Secretary has had regard to any submissions the body makes under paragraph (1)(b).
(3)
This regulation does not apply if the body applied for the variation.

Division 4A.7Australian conformity assessment body certificates4A.31Content of Australian conformity assessment body certificates

For the purposes of subsection 41EWB(2) of the Act, the information is all of the following:
(a)
the name and address of the body issuing the certificate;
(b)
the body’s ACN (within the meaning of the Corporations Act 2001);
(c)
the unique identification number assigned to the body under subsection 41EWA(4A) of the Act;
(d)
a unique identification number for the certificate;
(e)
the day on which the certificate is issued;
(f)
the name and address of the manufacturer of the medical devices;
(g)
the conformity assessment procedures applied to the medical devices by the manufacturer;
(h)
if the certificate covers a medical device to which paragraph 1.6(a), (b), (c) or (d) applies—the unique product identifier of the device;
(i)
if the certificate is varied—the day and details of the variation;
(j)
if one or more Australian conformity assessment body certificates have previously been issued in respect of the medical devices by the body—the information covered by paragraphs (a) to (i) in relation to each of those certificates.

Part 5Including medical devices in the RegisterDivision 5.1Including medical devices in the Register

Note: Regulation 5.1 is intentionally not used.

Subdivision AApplications5.2Matters to be certified – period for obtaining information from manufacturer (Act s 41FD)

For subparagraphs 41FD(e)(ii) and (g)(ii) of the Act, the period is 20 working days.

Subdivision CAuditing of applications5.3Selecting applications for auditing (Act s 41FH)

(1)
For the purposes of paragraph 41FH(1)(a) of the Act, and subject to this regulation, an application for any of the following kinds of medical devices to be included in the Register is prescribed:
(a)
a Class III medical device;
(b)
any of the following IVD medical devices:
(i)
a Class 3 IVD medical device;
(ii)
a Class 4 IVD medical device;
(iii)
a Class 4 in‑house IVD medical device;
(iv)
an IVD medical device that is intended for self‑testing;
(v)
an IVD medical device that is intended for point of care testing.
(2)
Subregulation (1) does not apply to an application for a kind of medical device to be included in the Register if a conformity assessment certificate, or an Australian conformity assessment body certificate, has been issued, and has not been suspended or revoked, in respect of the kind of medical device.
(2AA)
Subregulation (1) does not apply to an application for a kind of medical device to be included in the Register if:
(a)
an overseas regulator conformity assessment document has been issued, in respect of the kind of medical device, by a notified body (within the meaning of the Therapeutic Goods (Overseas Regulators) Determination 2018) in accordance with:
(i)
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, as in force from time to time; or
(ii)
Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices, as in force from time to time; and
(b)
the overseas regulator conformity assessment document has not been suspended or revoked.
(2AB)
Subregulation (1) does not apply to an application for a kind of medical device to be included in the Register if:
(a)
the kind of medical device:
(i)
is the subject of a medical device licence issued by Health Canada under the Medical Devices Regulations (Canada); or
(ii)
is the subject of an order approving an application for premarket approval from the US Food and Drug Administration under the Federal Food, Drug, and Cosmetic Act (United States of America); or
(iii)
is the subject of a pre‑market certification or approval issued by the Japanese Ministry of Health, Labour and Welfare, or the Japanese Pharmaceuticals and Medical Devices Agency, under The Law on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (Japan); or
(iv)
is the subject of an entry in the Register of Health Products kept and maintained by the Health Sciences Authority of Singapore under the Health Products Act 2007 (Singapore); or
(v)
has been certified in accordance with the Australia‑UK Mutual Recognition Agreement, the EC Mutual Recognition Agreement or the EFTA Mutual Recognition Agreement; and
(b)
the licence, order, approval, certification or entry has not:
(i)
been suspended, revoked or restricted (however described); or
(ii)
otherwise ceased to be in effect.
(2A)
Subregulation (1) does not apply to an application for a medical device that is covered by clause 5.8 of Schedule 2 or clause 1.8 of Schedule 2A.

Subdivision D—Miscellaneousmedical devices (priority applicant) determinations5.4Application of Subdivision

For the purposes of subsection 41FKA(1) of the Act, this Subdivision makes provision for and in relation to the making of medical devices (priority applicant) determinations.

5.4AApplication for medical devices (priority applicant) determination

(1)
A person may apply to the Secretary for a medical devices (priority applicant) determination in relation to a medical device.
(2)
An application under subregulation (1) must:
(a)
be in writing; and
(b)
be in a form approved, in writing, by the Secretary; and
(c)
have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.
(3)
An application under subregulation (1) is taken not to have been made unless:
(a)
the application meets the requirements in subregulation (2); and
(b)
the fee prescribed in item 1.5A of Part 1 of Schedule 5 for making the application has been paid.

5.4BMaking of medical devices (priority applicant) determination

(1)
On receiving an application under subregulation 5.4A(1) for a medical devices (priority applicant) determination in relation to a medical device, the Secretary must:
(a)
consider the application; and
(b)
decide either:
(i)
to make the determination; or
(ii)
to refuse to make the determination.
Criteria
(2)
The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medical device (the new device):
(a)
the intended purpose of the new device is the monitoring, treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;
(b)either:
(i) no medical devices with that intended purpose are of a kind included in the Register; or
(ii)
if one or more medical devices with that intended purposeare of a kind included in the Register (the existing devices)—there is substantial evidence demonstrating that the safety or performance of the new device when used for that intended purposeprovides a significant improvement compared to the existing devices;
(c)
at least one of the following applies to the new device:
(i)
the new device is a breakthrough technology and there is evidence that it offers a major clinical advantage over existing technology;
(ii)
there is evidence that the new device offers a major clinical advantage over existing alternatives included in the Register;
(iii)
the new device is an IVD medical device and its early availability in Australia will result in a major public health benefit.
Information to be specified in determination
(3)
The determination must specify:
(a)
the person who, as a result of section 41FKA of the Act, is the priority applicant; and
(b)
the medical device to which the determination relates; and
(c)
the intended purpose of the medical device.
Notification of decision
(4)
As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.
(5)
If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.

5.4CPeriod during which medical devices (priority applicant) determination is in force

(1)
A medical devices (priority applicant) determination in relation to a medical device:
(a)
comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 5.4B(4); and
(b)
subject to subregulation (2) and regulation 5.4D, remains in force for 6 months.
(2)
If the priority applicant specified in the determination makes an application under section 41FC of the Act for that kind of medical device to be included in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:
(a)
the priority applicant withdraws the application; or
(b)
the application lapses in accordance with section 41FK of the Act; or
(c)
the application is finally determined.
Note: See subsection 41FDB(3) of the Act for when an application passes preliminary assessment.

5.4DRevocation of medical devices (priority applicant) determination

(1)
The Secretary may revoke a medical devices (priority applicant) determination in relation to a medical device if:
(a)
either:
(i)
the priority applicant specified in the determination has not made an application under section 41FC of the Act for that kind of medical device to be included in the Register; or
(ii)
the priority applicant has made such an application, but the application does not pass preliminary assessment; and
(b)
the Secretary is satisfied that the criteria specified in subregulation 5.4B(2) are no longer satisfied in relation to the medical device.

ad F2018L00311
r 4A.4........................................	ad F2018L00311
r 4A.5........................................	ad F2018L00311
r 4A.6........................................	ad F2018L00311
am F2022L00600
r 4A.7........................................	ad F2018L00311
r 4A.8........................................	ad F2018L00311
r 4A.9........................................	ad F2018L00311
Division 4A.3
Subdivision A
r 4A.10......................................	ad F2018L00311
r 4A.11......................................	ad F2018L00311
r 4A.12......................................	ad F2018L00311
r 4A.13......................................	ad F2018L00311
r 4A.14......................................	ad F2018L00311
r 4A.15......................................	ad F2018L00311
r 4A.16......................................	ad F2018L00311
r 4A.17......................................	ad F2018L00311
r 4A.18......................................	ad F2018L00311
Subdivision B
r 4A.19......................................	ad F2018L00311
Division 4A.4
r 4A.20......................................	ad F2018L00311
r 4A.21......................................	ad F2018L00311
r 4A.22......................................	ad F2018L00311
r 4A.23......................................	ad F2018L00311
r 4A.24......................................	ad F2018L00311
Division 4A.5
r 4A.25......................................	ad F2018L00311
r 4A.26......................................	ad F2018L00311
r 4A.27......................................	ad F2018L00311
Division 4A.6
r 4A.28......................................	ad F2018L00311
r 4A.29......................................	ad F2018L00311
r 4A.30......................................	ad F2018L00311
Division 4A.7
r 4A.31......................................	ad F2018L00311
am F2019L01660
Part 5
Division 5.1
Subdivision A
Subdivision A heading.................	ad F2017L01561
Subdivision C
Subdivision C heading.................	ad F2017L01561
r 5.3...........................................	am No 25, 2010; No 282, 2011; No 38, 2014; No 159, 2014; No 188, 2015; F2016L00109; F2018L00311; F2018L01434; F2019L01660; F2021L01032; F2024L00686
Subdivision D
Subdivision D.............................	ad F2017L01561
r 5.4...........................................	rep No 282, 2011
ad F2017L01561
r 5.4A........................................	ad F2017L01561
r 5.4B........................................	ad F2017L01561
r 5.4C........................................	ad F2017L01561
am F2018L00311
r 5.4D........................................	ad F2017L01561
am F2018L00311
Division 5.2
r 5.6...........................................	rep F2023L00769
r 5.7...........................................	am F2020L00946; F2021L01474
r 5.8A........................................	ad F2021L01474
r 5.9...........................................	ad F2017L00853
r 5.10.........................................	ad F2017L00853
am F2019L01660
r 5.11.........................................	ad F2017L00853
am F2019L01660; F2020L00946
r 5.12.........................................	ad F2017L00853
am F2019L01660; F2024L00686
r 5.13.........................................	ad F2018L00865
am F2018L01434
Part 6A
Part 6A......................................	ad. 2010 No. 267
r. 6A.1.......................................	ad. 2010 No. 267
Part 7
Division 7.1
r 7.1...........................................	am F2021L01032; F2021L01474; F2023L01667
r 7.2...........................................	am F2017L01561; F2018L00311
Division 7.2
r 7.3...........................................	am F2016L00109
r 7.4...........................................	am F2023L00769; F2023L01558
r 7.5...........................................	am F2020L00946
Division 7.3
r 7.7...........................................	am F2017L00853
r 7.8...........................................	ad F2017L00853
Part 8
r. 8.1A.......................................	ad. 2011 No. 104
am No 75, 2015; F2016L00109
r 8.1...........................................	am F2019L01660
r 8.2...........................................	am F2017L00853
rep F2017L01561
Part 8AA
Part 8AA....................................	ad F2025L00414
r 8AA.1......................................	ad F2025L00414
r 8AA.2......................................	ad F2025L00414
am F2025L00414
r 8AA.3......................................	ad F2025L00414
Part 8A
Part 8A......................................	ad F2023L00770
r 8A.1........................................	ad F2023L00770
r 8A.2........................................	ad F2023L00770
r 8A.3........................................	ad F2023L00770
Part 9
Division 9.1
Division 9.1 heading....................	ad F2018L00311
Division 9.1A
Division 9.1A heading.................	am F2022L01300
Division 9.1A.............................	ad F2021L01474
r 9.1AA......................................	ad F2021L01474
am F2022L01300; F2022L01687; F2024L00689; F2025L00767
Division 9.2
Division 9.2................................	ad F2018L00311
r 9.1A........................................	ad F2018L00311
r 9.1B........................................	ad F2018L00311
r 9.1C........................................	ad F2018L00311
r 9.1D........................................	ad F2018L00311
r 9.1E.........................................	ad F2018L00311
r 9.1F.........................................	ad F2018L00311
Division 9.3
Division 9.3 heading....................	ad F2018L00311
am F2021L01474
r 9.2...........................................	am 2011 No 282
r 9.4...........................................	am 2003 No 153; 2004 No 128; 2005 No 193; 2006 No 214; 2007 No 163; 2008 No 119; 2009 No 181; 2010 No 132; 2011 No 104; 2012 No 147; No 94, 2013; No 62, 2014; No 87, 2015; F2016L00667; F2017L00552
rep F2018L00759
r. 9.6..........................................	ad. 2003 No. 153
r 9.7...........................................	ad No 153, 2003
am No 267, 2010; No 188, 2015; F2024L00689
r 9.8...........................................	ad F2021L01474
Division 9.4
Division 9.4................................	ad F2021L01474
r 9.9...........................................	ad F2021L01474
Part 9A
Part 9A......................................	ad F2025L00414
r 9A.1........................................	ad F2025L00414
Part 10
r. 10.1........................................	rs. 2003 No. 361
r. 10.2........................................	am. 2003 No. 259
r 10.3.........................................	am F2016L00109
r 10.3A......................................	ad F2019L01660
r 10.4AA....................................	ad F2020L00946
r 10.4A......................................	ad No 196, 2014
r 10.5.........................................	am F2016L00109
r 10.6.........................................	am F2024L00839
r 10.6A......................................	ad F2016L00109
am F2017L00853; F2017L01561; F2023L00769
r 10.6B.......................................	ad F2018L00311
r 10.7.........................................	am F2016L00109; F2017L01561; F2018L00311; F2021L01474; F2023L00769
ed C58
am F2023L00770; F2023L01558; F2023L01667; F2024L01299; F2024L01673; F2025L00414
Part 11
Part 11 heading...........................	rs No 63, 2014
Part 11.......................................	ad. 2012 No. 146
Division 11.1
Division 11.1..............................	ad No 63, 2014
Subdivision A
r 11.1.........................................	ad No 63, 2014
am No 188, 2015; F2018L00311
r 11.2.........................................	ad No 63, 2014
Subdivision B
r 11.3.........................................	ad No 63, 2014
r 11.4.........................................	ad No 63, 2014
r 11.5.........................................	ad No 63, 2014
Subdivision C
r 11.6.........................................	ad No 63, 2014
r 11.7.........................................	ad No 63, 2014
r 11.8.........................................	ad No 63, 2014
am F2018L00311
r 11.9.........................................	ad No 63, 2014
r 11.10.......................................	ad No 63, 2014
r 11.11.......................................	ad No 63, 2014
Subdivision D
r 11.12.......................................	ad No 63, 2014
r 11.13.......................................	ad No 63, 2014
r 11.14.......................................	ad No 63, 2014
Subdivision E
r 11.15.......................................	ad No 63, 2014
am No 188, 2015
r 11.16.......................................	ad No 63, 2014
r 11.17.......................................	ad No 63, 2014
am No 188, 2015; F2018L00311
r 11.18.......................................	ad No 63, 2014
rs No 188, 2015
am F2018L00311
r 11.19.......................................	ad No 63, 2014
rep No 188, 2015
Subdivision F
r 11.20.......................................	ad No 63, 2014
am No 188, 2015
r 11.21.......................................	ad No 63, 2014
rs No 188, 2015
Division 11.2
Division 11.2 heading..................	ad No 63, 2014
rs No 46, 2015
r 11.22A.....................................	ad No 46, 2015
r 11.22 (prev r 11.1).....................	ad No 146, 2012
am No 38, 2014; No 44, 2014
renum No 63, 2014
am No 46, 2015
rep F2024L00686
r 11.23.......................................	ad No 46, 2015
Division 11.3
Division 11.3..............................	ad No 188, 2015
r 11.24.......................................	ad No 188, 2015
r 11.25.......................................	ad No 188, 2015
r 11.26.......................................	ad No 188, 2015
Division 11.4
Division 11.4..............................	ad F2016L00109
r 11.27.......................................	ad F2016L00109
Division 11.5
Division 11.5..............................	ad F2017L01692
r 11.28.......................................	ad F2017L01692
r 11.29.......................................	ad F2017L01692
am F2021L01474
r 11.30.......................................	ad F2017L01692
rep F2021L01474
r 11.31.......................................	ad F2017L01692
Division 11.6
Division 11.6..............................	ad F2017L01561
r 11.32.......................................	ad F2017L01561
r 11.33.......................................	ad F2017L01561
Division 11.7
Division 11.7..............................	ad F2018L00516
r 11.34.......................................	ad F2018L00516
Division 11.8
Division 11.8..............................	ad F2018L00865
r 11.35.......................................	ad F2018L00865
r 11.36.......................................	ad F2018L00865
Division 11.9
Division 11.9..............................	ad F2018L01434
r 11.37.......................................	ad F2018L01434
Division 11.10
Division 11.10............................	ad F2019L01660
Subdivision A
r 11.38.......................................	ad F2019L01660
Subdivision B
r 11.39.......................................	ad F2019L01660
am F2020L00946; F2021L01474
r 11.40.......................................	ad F2019L01660
am F2020L00946; F2021L01474; F2023L01558
r 11.41.......................................	ad F2019L01660
am F2020L00946
r 11.42.......................................	ad F2019L01660
r 11.43.......................................	ad F2019L01660
am F2020L00946
exp end of 24 Nov 2022 (r 11.43(3))
Subdivision C
r 11.44.......................................	ad F2019L01660
am F2020L00946
r 11.45.......................................	ad F2019L01660
am F2020L00946; F2024L00686
r 11.46.......................................	ad F2019L01660
am F2020L00946
r 11.47.......................................	ad F2019L01660
am F2020L00946
Subdivision D
r 11.48.......................................	ad F2019L01660
am F2020L00946
r 11.49.......................................	ad F2019L01660
am F2020L00946
r 11.50.......................................	ad F2019L01660
am F2020L00946
r 11.51.......................................	ad F2019L01660
am F2020L00946; F2021L00450; F2023L01558; F2023L01667
r 11.52.......................................	ad F2019L01660
am F2020L00946; F2023L01558
r 11.53.......................................	ad F2019L01660
am F2020L00946
Subdivision E
r 11.54.......................................	ad F2019L01660
am F2022L01300; F2025L01157
Division 11.11
Division 11.11............................	ad F2020L00946
r 11.55.......................................	ad F2020L00946
r 11.56.......................................	ad F2020L00946
r 11.57.......................................	ad F2020L00946
Division 11.12
Division 11.12............................	ad F2021L01032
r 11.58.......................................	ad F2021L01032
am F2023L01667
Division 11.13
Division 11.13............................	ad F2021L01474
r 11.59.......................................	ad F2021L01474
r 11.60.......................................	ad F2021L01474
r 11.61.......................................	ad F2021L01474
r 11.62.......................................	ad F2021L01474
r 11.63.......................................	ad F2021L01474
r 11.64.......................................	ad F2021L01474
r 11.65.......................................	ad F2021L01474
rep F2023L01667
r 11.66.......................................	ad F2021L01474
Division 11.14
Division 11.14............................	ad F2021L01809
r 11.67.......................................	ad F2021L01809
Division 11.15
Division 11.15............................	ad F2022L01300
r 11.68.......................................	ad F2022L01300
Division 11.16
Division 11.16............................	ad F2022L01687
r 11.69.......................................	ad F2022L01687
r 11.70.......................................	ad F2022L01687
Division 11.17
Division 11.17............................	ad F2023L00769
r 11.71.......................................	ad F2023L00769
Division 11.18
Division 11.18............................	ad F2023L01558
r 11.72.......................................	ad F2023L01558
Division 11.19
Division 11.19............................	ad F2023L01667
r 11.73.......................................	ad F2023L01667
am F2024L00839
Division 11.20
Division 11.20............................	ad F2024L00686
r 11.74.......................................	ad F2024L00686
am F2024L00686
r 11.75.......................................	ad F2024L00686
r 11.76.......................................	ad F2024L00686
r 11.77 (first occurring)................	ad F2024L00686
Division 11.21
Division 11.21............................	ad F2024L00689
r 11.77 (second occurring)............	ad F2024L00689
renum
ed C63
r 11.78 (prev r 11.77 second occurring)
Division 11.22
Division 11.22............................	ad F2024L00839
r 11.79.......................................	ad F2024L00839
r 11.80.......................................	ad F2024L00839
r 11.81.......................................	ad F2024L00839
(2) exp end of 31 Dec 2024 (r 11.81(3))
Division 11.23
Division 11.23............................	ad F2024L01673
r 11.82.......................................	ad F2024L01673
r 11.83.......................................	ad F2024L01673
r 11.84.......................................	ad F2024L01673
Division 11.24
Division 11.24............................	ad F2025L00414
r 11.85.......................................	ad F2025L00414
Division 11.25
Division 11.25............................	ad F2025L00767
r 11.86.......................................	ad F2025L00767
Schedule 1
Schedule 1..................................	am No 259, 2003; No 25, 2010; F2016L00109
ed C33
am F2017L01692
ed C39
am F2019L01660; F2021L01474; F2021L01809; F2022L00243; F2022L01687; F2024L00686; F2025L00414
Schedule 2
Schedule 2 heading......................	rs No 25, 2010
Schedule 2..................................	am F2019L01660
Part 1
c 1.1..........................................	am F2019L01660
Part 2
c 2.4..........................................	am F2019L01660
Part 3
c 3.1..........................................	am F2019L01660; F2021L01474
c 3.2..........................................	am F2019L01660; F2021L01474
c 3.3..........................................	am F2019L01660
c 3.4..........................................	am No 146, 2012; No 46, 2015; F2017L01692; F2019L01660; F2021L01474
Part 4
c 4.2..........................................	am F2019L01660
c 4.3..........................................	ed C32
c 4.5..........................................	ad F2019L01660
c 4.6..........................................	ad F2019L01660
c 4.7..........................................	ad F2019L01660
c 4.8..........................................	ad F2019L01660
Part 5
c 5.4..........................................	rs F2019L01660
c 5.5..........................................	rs F2024L00686
c 5.7..........................................	am F2019L01660
c 5.8..........................................	am No 25, 2010
c 5.10.........................................	ad F2021L01474
c 5.11.........................................	ad F2021L01474
Schedule 2A
Schedule 2A...............................	ad No 25, 2010
am F2019L01660
c 1.1..........................................	ad No 25, 2010
c 1.2..........................................	ad No 25, 2010
c 1.3..........................................	ad No 25, 2010
am No 188, 2015; F2019L01660
c 1.4..........................................	ad No 25, 2010
c 1.5..........................................	ad No 25, 2010
c 1.6..........................................	ad No 25, 2010
c 1.7..........................................	ad No 25, 2010
c 1.8..........................................	ad No 25, 2010
Schedule 3
Part 1
c 1.1..........................................	am No 25, 2010; F2018L00311; F2019L01660
c 1.3..........................................	am F2018L00311
c 1.4..........................................	am No 25, 2010; F2017L00853; F2018L00311; F2020L00946
c 1.5..........................................	am F2018L00311
c 1.6..........................................	am No 25, 2010; F2018L00311; F2019L01660
c 1.8..........................................	am F2018L00311; F2019L01660
c 1.9..........................................	am No 25, 2015; F2018L00311; F2019L01660
Part 2
c 2.1..........................................	am F2018L00311
c 2.3..........................................	am No 25, 2010; F2018L00311
c 2.4..........................................	am F2018L00311
c 2.5..........................................	am F2018L00311
Part 3
c 3.1..........................................	am F2018L00311
c 3.3..........................................	am F2018L00311
c 3.4..........................................	am F2017L00853; F2018L00311; F2020L00946
c 3.5..........................................	am F2018L00311; F2019L01660
c 3.6..........................................	am F2018L00311; F2019L01660
Part 4
c 4.1..........................................	am F2018L00311
c 4.3..........................................	am F2018L00311
c 4.4..........................................	am F2017L00853; F2018L00311; F2020L00946
c 4.5..........................................	am F2018L00311
c 4.7..........................................	am No 25, 2010; No 188, 2015; F2018L00311; F2019L01660
c 4.8..........................................	am No 25, 2010; No 188, 2015; F2018L00311; F2019L01660
Part 5
c 5.1..........................................	am F2018L00311
c 5.3..........................................	am F2018L00311
c 5.4..........................................	am F2017L00853; F2018L00311; F2020L00946
c 5.5..........................................	am F2018L00311
c 5.7..........................................	am F2018L00311; F2019L01660
c 5.8..........................................	am F2018L00311
Part 6
c 6.5..........................................	am F2017L00853; F2020L00946
c 6.6..........................................	am No 25, 2010; F2018L00311; F2019L01660
Part 6A
Part 6A heading..........................	rs No 188, 2015
Part 6A......................................	ad No 25, 2010
c 1.1..........................................

ad No 25, 2010
rs and renum No 188, 2015
c 6A.1 (prev c 1.1)
c 1.2..........................................	ad No 25, 2010
am No 63, 2014
rs and renum No 188, 2015
c 6A.2 (prev c 1.2)......................	am F2018L00311
c 1.3..........................................	ad No 25, 2010
am No 188, 2015
renum No 188, 2015
c 6A.3 (prev c 1.3)
c 1.4..........................................	ad No 25, 2010
rs and renum No 188, 2015
c 6A.4 (prev c 1.4)
Part 6B
Part 6B.......................................	ad No 188, 2015
c 6B.1........................................	ad No 188, 2015
am F2020L00946
c 6B.2........................................	ad No 188, 2015
c 6B.3........................................	ad No 188, 2015
c 6B.4........................................	ad No 188, 2015
c 6B.5........................................	ad No 188, 2015
c 6B.6........................................	ad No 188, 2015
am F2019L01660
c 6B.7........................................	ad No 188, 2015
c 6B.8........................................	ad F2020L00946
Part 7
c 7.1..........................................	am F2019L01660
c 7.2..........................................	am No 25, 2010; F2017L00853; F2019L01660
c 7.5..........................................	am No 32, 2011; F2017L00853; F2020L00946; F2021L01474
c 7.6..........................................	am F2019L01660
Schedule 3AA
Schedule 3AA............................	ad F2018L00311
c 1.............................................	ad F2018L00311
c 2.............................................	ad F2018L00311
c 3.............................................	ad F2018L00311
am F2023L00769
c 4.............................................	ad F2018L00311
c 5.............................................	ad F2018L00311
am F2023L00769
c 6.............................................	ad F2018L00311
am F2023L00769
c 7.............................................	ad F2018L00311
Schedule 3A
Schedule 3A...............................	ad No 267, 2010
am No 104, 2011; F2017L00853; F2018L00311
Schedule 4
Schedule 4..................................	am No 78, 2004; No 270, 2008; No 25, 2010; No 267, 2010; No 90, 2015; No 188, 2015; F2017L00853
ed C32
am F2018L00311; F2018L00516; F2019L01660; F2020L00946; F2020L01598; F2020L01645; F2021L01032; F2021L00450; F2021L01474; F2021L01809; F2022L01687; F2023L00769; F2023L01558; F2023L01667; F2024L00686; F2024L00689; F2024L00839; Act No 50, 2024; F2024L01673; F2025L00767
Schedule 5
Schedule 5..................................	am No 153, 2003; No 128, 2004; No 193, 2005; No 214, 2006; No 163, 2007; No 119, 2008; No 181, 2009; No 25, 2010; No 132, 2010; No 104, 2011; No 147, 2012; No 94, 2013; No 62, 2014; No 87, 2015; No 188, 2015; F2016L00667; F2017L00552; F2017L00853; F2017L01561; F2018L00311; F2018L00759; F2018L01434; F2019L00396; F2019L01660; F2020L00720; F2021L00688; F2021L01474
ed C52
am F2022L00600; F2023L00770; F2024L00689; F2025L00767
Dictionary
Dictionary..................................	am No 25, 2010; No 267, 2010; No 196, 2014; No 46, 2015; No 188, 2015; F2016L00109; F2017L00853; F2017L01561; F2017L01692; F2018L00311
ed C40
am F2019L01660; F2020L00946; F2021L01474; F2022L00243; F2022L01687; F2023L01667; F2024L00839; F2025L00414