Therapeutic Goods (Medical Devices—Authorised Supply) Rules 2022 (Cth)

Therapeutic Goods (Medical Devices—Authorised Supply) Rules 2022

made under subsection 41HC(6) of the

Therapeutic Goods Act 1989

Compilation No. 4

Compilation date: 21 August 2025

Includes amendments: F2025L00947

About this compilation

This compilation

This is a compilation of the Therapeutic Goods (Medical Devices—Authorised Supply) Rules 2022 that shows the text of the law as amended and in force on 21 August 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.

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If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.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

1. •
2. •
3. •
4. •

1

Name

This instrument is the Therapeutic Goods (Medical Devices—Authorised Supply) Rules 2022.

3

Authority

This instrument is made under subsection 41HC(6) of the Therapeutic Goods Act 1989.

4

Definitions

Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:

(a) health practitioner;

(b) included in the Register;

(c) medical device;

(d) Register;

(e) sponsor;

(f) supply.

In this instrument:

Act means the Therapeutic Goods Act 1989.

SAS Guidance means the document titled Special Access Scheme (SAS): Guidance for health practitioners accessing unapproved therapeutic goods (Version 3.0, October 2024) published by the Therapeutic Goods Administration, as in force or existing on 1 October 2024.

Note: The SAS Guidance is published at Goods Administration has the same meaning as in the Therapeutic Goods Regulations 1990.

5Authorisation

Supply by a specified health practitioner

(1)

A health practitioner specified in column 4 of an item in the table in Schedule 1 is authorised to supply a kind of medical device to a patient of that practitioner where:

1. (a)

   the kind of medical device is specified in column 2 of that item; and

2. (b)

   the supply is for the purpose specified in column 3 of that item; and

3. (c)

   the conditions specified in subsection (2) are satisfied.

(2)

The health practitioner must:

1. (a)

   inform the patient, or a parent or guardian of the patient, that the kind of medical device is not included in the Register; and

2. (b)

   obtain informed consent from the patient, or a parent or guardian of the patient, in relation to, and before, the supply of the kind of medical device; and

3. (c)

   supply the kind of medical device in accordance with good medical practice; and

4. (d)

   if the health practitioner becomes aware that the patient has suffered an adverse event in relation to the kind of medical device—notify the Therapeutic Goods Administration and the sponsor of the kind of medical device about the adverse event in accordance with the reporting guidelines set out in the SAS Guidance; and

5. (e)

   if the health practitioner becomes aware of a defect in the kind of medical device—notify the Therapeutic Goods Administration and the sponsor of the kind of medical device in accordance with the reporting guidelines set out in the SAS Guidance.

Supply to a patient of a specified health practitioner

(3)

A health practitioner is authorised to supply a kind of medical device to a patient of a health practitioner specified in column 4 of an item in the table in Schedule 1 (the treating practitioner) where:

1. (a)

   the kind of medical device is specified in column 2 of that item; and

2. (b)

   the supply is requested by the treating practitioner; and

3. (c)

   the supply is for the purpose specified in column 3 of that item; and

4. (d)

   the conditions specified in subsection (4) are satisfied.

(4)

The health practitioner supplying the medical device must:

1. (a)

   if the health practitioner becomes aware that the patient has suffered an adverse event in relation to the kind of medical device—notify the Therapeutic Goods Administration and the sponsor of the kind of medical device about the adverse event in accordance with the reporting guidelines set out in the SAS Guidance; and

2. (b)

   if the health practitioner becomes aware of a defect in the kind of medical device—notify the Therapeutic Goods Administration and the sponsor of the medical device in accordance with the reporting guidelines set out in the SAS Guidance.

Schedule 1—Medical devices authorised for supply

Note: See section 5.

Specified therapeutic goods
Column 1	Column 2	Column 3	Column 4
Item	Kind of medical device	Purpose	Health practitioner
1	14/16 Taper Femoral Heads – Oxinium – Smith & Nephew (71342280 – 71342368)	revision hip arthroplasty	orthopaedic surgeon
4	AltiVate Reverse Shoulder system – DJO Global	for arthroplasty of the shoulder	orthopaedic surgeon
7	CelGro Type I/III collagen scaffold – Orthocell	articular cartilage repair: collagen scaffold for use with autologous chondrocyte implantation (ACI) to knee (including patellofemoral) and ankle joint; or augmentation of rotator cuff tendon repair	orthopaedic surgeon
8	CollaCote Dressing	for haemostasis or to protect the wound surface during dental procedures	dental practitioner
9	CollaPlug Absorbable Collagen Wound Dressing	for haemostasis or to protect the wound surface during dental procedures	dental practitioner
10	CollaTape Absorbable Collagen	for haemostasis or to protect the wound surface during dental procedures	dental practitioner
11	Duraloc Acetabular Cup System – Hip Insert/Liner – Johnson & Johnson t/a DePuy Synthes	revision hip arthroplasty	orthopaedic surgeon
15	Endotine Forehead	for use in subperiosteal browplasty surgery	ophthalmologist; plastic surgeon
16	Endotine Midface	for use in subperiosteal midface suspension surgery	plastic surgeon
19	Insall/Burstein II Modular Knee System - Posterior Stabilised Tibial Articular Surface – Zimmer Biomet (00522003101 – 00522003506)	revision knee arthroplasty	orthopaedic surgeon
21	MG II Total Knee System - Tibial Articular Surface – Zimmer Biomet (00511002309 – 00511005323)	revision knee arthroplasty	orthopaedic surgeon
22	M/G Unicompartmental Knee System - Tibial Articulating Surface – Zimmer Biomet (00578804008 – 00578808014)	revision knee arthroplasty	orthopaedic surgeon
23	Natural Knee II System – Durasul PE Congruent Tibial Insert – Zimmer Biomet (620108809 – 620110916)	revision knee arthroplasty	orthopaedic surgeon
24	NexGen Complete Knee Solution – Cruciate Retaining (CR) Articular Surface – Zimmer Biomet (00597002009 – 00597005020)	revision knee arthroplasty	orthopaedic surgeon
25	NexGen Complete Knee Solution Legacy PS - Articular Surface – Zimmer Biomet (5996-020-09 to 00-5996-022-23 AND 00-5996-030-09 to 00-5996-051-20)	revision knee arthroplasty	orthopaedic surgeon
26	NexGen Complete Knee Solution Mobile Bearing Knee System - Articular Surface – Zimmer Biomet (00594203109 – 00594207217)	revision knee arthroplasty	orthopaedic surgeon
27	NexGen Complete Knee Solution – Posterior Stabilized (PS) Articular Surface – Zimmer Biomet (00598202010 – 00598205123)	revision knee arthroplasty	orthopaedic surgeon
28	Omnifit Crossfire Series II Cup Insert – Stryker Orthopaedics (2041C2240 - 2041C3274)	revision hip arthroplasty	orthopaedic surgeon
28A	Origin Stem, Cox Vara, Sizes 9 to 18 – Signature Orthopaedics	hip arthroplasty	orthopaedic surgeon
29	Primetech Piezo Micro Manipulator and microinjection pipettes	in vitro fertilisation	obstetrics and gynaecology specialist
30	Pro Osteon® Bone Graft Substitute 200R	for use as a bone graft substitute only for bony voids or gaps that are not intrinsic to the stability of the bony structure	medical practitioner; dental practitioner
31	Pro Osteon® Bone Graft Substitute 500R	for use as a bone graft substitute only for voids or gaps that are not intrinsic to the stability of the bony structure	medical practitioner
32	Quintip Individual Skin Test System	for allergy skin testing using puncture to apply the test extract	medical practitioner
33	Reflection Ceramic Acetabular System - Reflection Biolox Forte Ceramic Acetabular Liner – Smith & Nephew (71338146 – 71338456)	revision hip arthroplasty	orthopaedic surgeon
34	Regeneten Bioinductive Implant – Bone Anchors with Arthroscopic Delivery System	rotator cuff surgery	orthopaedic surgeon
35	SeleXys Hip System – Inlay Bionit2 – Mathys Orthopaedics (55462803 – 55463612)	revision hip arthroplasty	orthopaedic surgeon
35A	Taurolock-U25.000 ((cyclo)-taurolidine, citrate (4%) and urokinase (25.000 IU))	for use as a catheter lock solution, instilled into a port or a silicone or polyurethane catheter‑based device at the termination of a treatment, and is withdrawn prior to subsequent treatments	nephrology physician
36	Trilogy AB Alternate Bearing Shell Insert – Zimmer Biomet (00640502601 – 00640503206 AND 00641502802 – 00641503206)	revision hip arthroplasty	orthopaedic surgeon

Endnotes

Endnote 1About the endnotes

The endnotes provide information about this compilation and the compiled law.

The following endnotes are included in every compilation:

Endnote 1—About the endnotes

Endnote 2—Abbreviation key

Endnote 3—Legislation history

Endnote 4—Amendment history

Abbreviation key—Endnote 2

The abbreviation key sets out abbreviations that may be used in the endnotes.

Legislation history and amendment history—Endnotes 3 and 4

Amending laws are annotated in the legislation history and amendment history.

The legislation history in endnote 3 provides information about each law that has amended (or will amend) the compiled law. The information includes commencement details for amending laws and details of any application, saving or transitional provisions that are not included in this compilation.

The amendment history in endnote 4 provides information about amendments at the provision (generally section or equivalent) level. It also includes information about any provision of the compiled law that has been repealed in accordance with a provision of the law.

Misdescribed amendments

A misdescribed amendment is an amendment that does not accurately describe how an amendment is to be made. If, despite the misdescription, the amendment can be given effect as intended, then the misdescribed amendment can be incorporated through an editorial change made under section 15V of the Legislation Act 2003.

If a misdescribed amendment cannot be given effect as intended, the amendment is not incorporated and “(md not incorp)” is added to the amendment history.

Endnote 2Abbreviation key

ad = added or inserted	orig = original
am = amended	p = page(s)
amdt = amendment	para = paragraph(s)/subparagraph(s)
C[x] = Compilation No. x	/sub‑subparagraph(s)
ch = Chapter(s)	pres = present
cl = clause(s)	prev = previous
cont. = continued	(prev…) = previously
def = definition(s)	pt = Part(s)
Dict = Dictionary	r = regulation(s)/Court rule(s)
disallowed = disallowed by Parliament	reloc = relocated
div = Division(s)	renum = renumbered
exp = expires/expired or ceases/ceased to have	rep = repealed
effect	rs = repealed and substituted
gaz = gazette	s = section(s)/subsection(s)
LA = Legislation Act 2003	/rule(s)/subrule(s)/order(s)/suborder(s)
LIA = Legislative Instruments Act 2003	sch = Schedule(s)
(md not incorp) = misdescribed amendment	SLI = Select Legislative Instrument
cannot be given effect	SR = Statutory Rules
mod = modified/modification	sub ch = Sub‑Chapter(s)
No. = Number(s)	sub div = Subdivision(s)
Ord = Ordinance	sub pt = Subpart(s)
underlining = whole or part not
commenced or to be commenced

Endnote 3Legislation history

Name	Registration	Commencement	Application, saving and transitional provisions
Therapeutic Goods (Medical Devices—Authorised Supply) Rules 2022	20 Dec 2022 (F2022L01711)	21 Dec 2022	—
Therapeutic Goods (Medicines—Authorised Supply) Amendment (Vaping) Rules 2023	15 Dec 2023 (F2023L01683)	1 Jan 2024	—
Therapeutic Goods (Authorised Supply) Amendment (SAS Guidance) Rules 2024	6 Jun 2024 (F2024L00639)	5 Jun 2024	—
Therapeutic Goods (Authorised Supply) Amendment (SAS Guidance) Rules (No. 2) 2024	16 Oct 2024 (F2024L01321)	17 Oct 2024	—
Therapeutic Goods (Authorised Supply) Amendment Rules 2025	20 Aug 2025 (F2025L00947)	Sch 1, Part 1: 21 Aug 2025 (s 2(1) item 2) Sch 1, Part 2: awaiting commencement (s 2(1) item 3)	—

Endnote 4Amendment history

Provision affected	How affected
s 2……………………………….	rep LA s 48D
s 4……………………………….	am F2023L01683; F2024L00639; F2024L01321; F2025L00947
s 5……………………………….	am F2025L00947
s 6……………………………….	rep LA s 48C
Schedule 1………………………	am F2025L00947
Schedule 2………………………	rep LA s 48C