Therapeutic Goods (Medical Devices—Authorised Supply) Rules 2022
made under subsection 41HC(6) of the
Therapeutic Goods Act 1989
Compilation No. 2
Compilation date: 5 June 2024
Includes amendments up to: F2024L00639
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 5 June 2024 (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. Any uncommenced amendments affecting the law are accessible on the Register (www.legislation.gov.au). The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. For more information on any uncommenced amendments, see the Register for the compiled law.
Application, saving and transitional provisions for provisions and amendments
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. For more information on any modifications, see the Register for the compiled law.
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If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.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 Name
3 Authority
4 Definitions
5 Authorisation
Schedule 1—Medical devices authorised for supply
Endnotes
Endnote 1—About the endnotes
Endnote 2—Abbreviation key
Endnote 3—Legislation history
Endnote 4—Amendment history
This instrument is the Therapeutic Goods (Medical Devices—Authorised Supply) Rules 2022.
This instrument is made under subsection 41HC(6) of the Therapeutic Goods Act 1989.
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 2.0, March 2024) published by the Therapeutic Goods Administration, as in force or existing on 1 April 2024.
Note: The SAS Guidance is published at www.tga.gov.au.
Therapeutic Goods Administration has the same meaning as in the Therapeutic Goods Regulations 1990.
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:
(a) the kind of medical device is specified in column 2 of that item; and
(b) the supply is for the purpose specified in column 3 of that item; and
(c) the conditions specified in subsection (2) are satisfied.
(2) The health practitioner must:
(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
(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
(c) supply the kind of medical device in accordance with good medical practice; and
(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
(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:
(a) the kind of medical device is specified in column 2 of that item; and
(b) the supply is requested by the treating practitioner; and
(c) the supply is for the purpose specified in column 3 of that item; and
(d) the conditions specified in subsection (4) are satisfied.
(4) The health practitioner supplying the medical device must:
(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
(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 | |
2 | Aequalis PerForm Plus Reversed Glenoid – Wright Medical | for arthroplasty of the shoulder | orthopaedic surgeon | |
3 | Aequalis PerForm Reversed Glenoid – Wright Medical | for arthroplasty of the shoulder | orthopaedic surgeon | |
4 | AltiVate Reverse Shoulder system – DJO Global | for arthroplasty of the shoulder | orthopaedic surgeon | |
5 | Biodesign Enterocutaneous Fistula Plug | for repair of enterocutaneous fistulae | general surgeon | |
6 | BlastGen | culture of embryos from the 4-8 cell stage through to the blastocyst stage; or embryo transfer | obstetrics and gynaecology specialist | |
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 | |
12 | EmbryoGen (Product No. 1203) | fertilisation and culture until the 2-8 cell stage; or embryo transfer at day 2 or 3 | obstetrics and gynaecology specialist | |
13 | EmbryoGen & BlastGen (Product No. 1206) | culture of embryos until the 2-8 cell stage (Embryogen) and culture of embryos from the 4-8 cell stage through to the blastocyst stage (Blastgen); or embryo transfer | obstetrics and gynaecology specialist | |
14 | EmbryoGen V2 (Product No. 1204) | culture of human embryos until the 2-8 cell stage; or embryo transfer at day 2 or 3 | obstetrics and gynaecology specialist | |
15 | Endotine Forehead | for use in subperiosteal browplasty surgery | plastic surgeon | |
16 | Endotine Midface | for use in subperiosteal midface suspension surgery | plastic surgeon | |
17 | GM508 CultActive | for investigation of fertilization failure after previous ICSI-cycles | obstetrics and gynaecology specialist | |
18 | Ilex Skin Protectant | for use on a variety of dermal wounds and stomal irritations as a topical skin barrier | medical practitioner; nurse practitioner | |
19 | Insall/Burstein II Modular Knee System - Posterior Stabilised Tibial Articular Surface – Zimmer Biomet (00522003101 – 00522003506) | revision knee arthroplasty | orthopaedic surgeon | |
20 | Jupiter Sternal Protection Device | for use following median sternotomy incisions to add a protective layer over the entire cut surfaces of the sternal bone | cardiothoracic 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 | |
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 | |
36 | Trilogy AB Alternate Bearing Shell Insert – Zimmer Biomet (00640502601 – 00640503206 AND 00641502802 – 00641503206) | revision hip arthroplasty | orthopaedic surgeon | |
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.
ad = added or inserted | orig = original |
am = amended | par = paragraph(s)/subparagraph(s) |
amdt = amendment | /sub‑subparagraph(s) |
c = clause(s) | pres = present |
C[x] = Compilation No. x | prev = previous |
Ch = Chapter(s) | (prev…) = previously |
def = definition(s) | Pt = Part(s) |
Dict = Dictionary | r = regulation(s)/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 |
F = Federal Register of Legislation | s = section(s)/subsection(s) |
gaz = gazette | Sch = Schedule(s) |
LA = Legislation Act 2003 | Sdiv = Subdivision(s) |
LIA = Legislative Instruments Act 2003 | SLI = Select Legislative Instrument |
(md not incorp) = misdescribed amendment | SR = Statutory Rules |
cannot be given effect | Sub‑Ch = Sub‑Chapter(s) |
mod = modified/modification | SubPt = Subpart(s) |
No. = Number(s) | underlining = whole or part not |
o = order(s) | commenced or to be commenced |
Ord = Ordinance |
|
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 | — |
Provision affected | How affected |
s 2………………………………. | rep LA s 48D |
s 4………………………………. | am F2023L01683; am F2024L00639 |
s 6………………………………. | rep LA s 48C |
Schedule 2……………………… | rep LA s 48C |