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Rules/Other as amended, taking into account amendments up to Therapeutic Goods (Authorised Supply) Amendment (Medicines and Medical Devices) Rules 2022
Administered by: Health and Aged Care
Registered 21 Feb 2022
Start Date 11 Feb 2022
Table of contents.

Commonwealth Coat of Arms of Australia

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If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.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

Endnotes                                                                                                                        7

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 www.tga.gov.au.

Therapeutic 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