Therapeutic Goods (Medical Devices—Authorised Supply) Rules 2020 (Cth)
made under subsection 41HC(6) of the
This is a compilation of the
The notes at the end of this compilation (the
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.
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.
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.
If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.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
• • • •
This instrument is the
Therapeutic Goods (Medical Devices—Authorised Supply) Rules 2020 .
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; and
(f) supply.
In this instrument:
Act means theTherapeutic Goods Act 1989 .
SAS Guidance means the document titledSpecial 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 notcommenced 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
0
0
0