Therapeutic Goods (Medical Devices—Authorised Supply) Rules 2020 (Cth)
Therapeutic Goods (Medical Devices—Authorised Supply) Rules 2020
made under subsection 41HC(6) of the
Therapeutic Goods Act 1989
Compilation No. 1
Compilation date: 11 February 2022
Includes amendments up to: F2022L00123
About this compilation
This compilation
This is a compilation of the Therapeutic Goods (Medical Devices—Authorised Supply) Rules 2020 that shows the text of the law as amended and in force on 11 February 2022 (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 Legislation Register ( 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 series page on the Legislation 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 series page on the Legislation 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If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.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........................................................................................................................................ 1
3 Authority.................................................................................................................................. 1
4 Definitions................................................................................................................................ 1
5 Authorisation............................................................................................................................ 1
Schedule 1—Medical devices authorised for supply 3
Endnotes7
Endnote 1—About the endnotes 7
Endnote 2—Abbreviation key 8
Endnote 3—Legislation history 9
Endnote 4—Amendment history 10
1 Name
This instrument is the Therapeutic Goods (Medical Devices—Authorised Supply) Rules 2020.
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; and
(f) supply.
In this instrument:
Act means the Therapeutic Goods Act 1989.
SAS Guidance means the document titled Special Access Scheme Guidance for health practitioners and sponsors (Version 1.1, September 2017) published by the Therapeutic Goods Administration, as in force or existing at the commencement of this instrument.
Note: The SAS Guidance is published at Goods Administration has the same meaning as in the Therapeutic Goods Regulations 1990.
5 Authorisation
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 4A 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
(Product No. 1205)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 10A Duraloc Acetabular Cup System – Hip Insert/Liner – Johnson & Johnson t/a DePuy Synthes revision hip arthroplasty orthopaedic surgeon 11 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 12 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 13 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 14 Endotine Forehead for use in subperiosteal browplasty surgery plastic surgeon 15 Endotine Midface for use in subperiosteal midface suspension surgery plastic surgeon 16 Geistlich Fibro-Gide – Geistlich Pharma dental filling material dental practitioner 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 Journey II Bi-Cruciate Stabilized (BCS) Total Knee System - Articular Insert – Smith & Nephew (74027211 – 74027288) revision knee arthroplasty orthopaedic surgeon 21 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 24 MG II Total Knee System - Tibial Articular Surface – Zimmer Biomet (00511002309 – 00511005323) revision knee arthroplasty orthopaedic surgeon 25 M/G Unicompartmental Knee System - Tibial Articulating Surface – Zimmer Biomet
(00578804008 – 00578808014)
revision knee arthroplasty orthopaedic surgeon 26 Natural Knee II System – Durasul PE Congruent Tibial Insert – Zimmer Biomet (620108809 – 620110916) revision knee arthroplasty orthopaedic surgeon 27 NexGen Complete Knee Solution – Cruciate Retaining (CR) Articular Surface – Zimmer Biomet (00597002009 – 00597005020) revision knee arthroplasty orthopaedic surgeon 28 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 29 NexGen Complete Knee Solution Mobile Bearing Knee System - Articular Surface – Zimmer Biomet (00594203109 – 00594207217) revision knee arthroplasty orthopaedic surgeon 30 NexGen Complete Knee Solution – Posterior Stabilized (PS) Articular Surface – Zimmer Biomet (00598202010 – 00598205123) revision knee arthroplasty orthopaedic surgeon 31 Omnifit Crossfire Series II Cup Insert – Stryker Orthopaedics (2041C2240 - 2041C3274) revision hip arthroplasty orthopaedic surgeon 31A Primetech Piezo Micro Manipulator and microinjection pipettes in vitro fertilisation obstetrics and gynaecology specialist 32 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 33 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 34 Quintip Individual Skin Test System for allergy skin testing using puncture to apply the test extract medical practitioner 35 Reflection Ceramic Acetabular System - Reflection Biolox Forte Ceramic Acetabular Liner – Smith & Nephew (71338146 – 71338456) revision hip arthroplasty orthopaedic surgeon 35A Regeneten Bioinductive Implant – Bone Anchors with Anthroscopic Delivery System rotator cuff surgery orthopaedic surgeon 36 SeleXys Hip System – Inlay Bionit2 – Mathys Orthopaedics (55462803 – 55463612) revision hip arthroplasty orthopaedic surgeon 37 Trilogy AB Alternate Bearing Shell Insert – Zimmer Biomet (00640502601 – 00640503206 AND 00641502802 – 00641503206) revision hip arthroplasty orthopaedic surgeon Endnotes
Endnote 1—About 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 the amendment to be made. If, despite the misdescription, the amendment can be given effect as intended, the amendment is incorporated into the compiled law and the abbreviation “(md)” added to the details of the amendment included in the amendment history.
If a misdescribed amendment cannot be given effect as intended, the abbreviation “(md not incorp)” is added to the details of the amendment included in the amendment history.
Endnote 2—Abbreviation key
ad = added or inserted o = order(s) am = amended Ord = Ordinance amdt = amendment orig = original c = clause(s) par = paragraph(s)/subparagraph(s) C[x] = Compilation No. x /sub‑subparagraph(s) Ch = Chapter(s) pres = present def = definition(s) prev = previous Dict = Dictionary (prev…) = previously disallowed = disallowed by Parliament Pt = Part(s) Div = Division(s) r = regulation(s)/rule(s) exp = expires/expired or ceases/ceased to have reloc = relocated effect renum = renumbered F = Federal Register of Legislation rep = repealed gaz = gazette rs = repealed and substituted LA = Legislation Act 2003 s = section(s)/subsection(s) LIA = Legislative Instruments Act 2003 Sch = Schedule(s) (md) = misdescribed amendment can be given Sdiv = Subdivision(s) effect 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 commenced or to be commenced Endnote 3—Legislation history
Name Registration Commencement Application, saving and transitional provisions Therapeutic Goods (Medical Devices—Authorised Supply) Rules 2020 17 Sep 2020
(F2020L01174)
18 Sep 2020 — Therapeutic Goods (Authorised Supply) Amendment (Medicines and Medical Devices) Rules 2022 10 Feb 2022
(F2022L00123)
11 Feb 2022 — Endnote 4—Amendment history
Provision affected How affected s 2........................................ rep LA s 48D s 6........................................ rep LA s 48C Sch 1.................................... am F2022L00123 Sch 2.................................... rep LA s 48C
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