Federal Register of Legislation - Australian Government

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Rules/Other as made
This instrument authorises the supply of specified kinds of medical devices by specified health practitioners to specified recipients provided specified conditions are met.
Administered by: Health
Registered 17 Sep 2020
Tabling HistoryDate
Tabled HR06-Oct-2020
Tabled Senate06-Oct-2020
Table of contents.

Commonwealth Coat of Arms of Australia

 

Therapeutic Goods (Medical Devices—Authorised Supply) Rules 2020

I, Jane Cook, as delegate of the Minister for Health, make the following rules.

Dated 15 September 2020

Dr Jane Cook

First Assistant Secretary
Medicines Regulation Division
Health Products Regulation Group
Department of Health

 

 


Contents

1  Name........................................................................................................................................ 1

2  Commencement........................................................................................................................ 1

3  Authority.................................................................................................................................. 1

4  Definitions................................................................................................................................ 1

5  Authorisation............................................................................................................................ 2

6  Repeals..................................................................................................................................... 3

Schedule 1—Medical devices authorised for supply                                                  4

Schedule 2—Repeals                                                                                                     8

Therapeutic Goods (Authorised Supply of Specified Medical Devices) Rules March 2018   8

 

 


1  Name

                   This instrument is the Therapeutic Goods (Medical Devices—Authorised Supply) Rules 2020.

2  Commencement

             (1)  Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

 

Commencement information

Column 1

Column 2

Column 3

Provisions

Commencement

Date/Details

1.  The whole of this instrument

The day after this instrument is registered.

 

Note:          This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

             (2)  Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

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.

Repeals

                   Each instrument that is specified in Schedule 2 is repealed as set out in the applicable items in that Schedule.

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

Aequalis Pyrocarbon Humeral Head – Tornier

partial shoulder joint replacement

orthopaedic surgeon

 

5

Biodesign Enterocutaneous Fistula Plug

for repair of enterocutaneous fistulae

medical practitioner

 

6

BlastGen
(Product No. 1205)

culture of embryos from the 4-8 cell stage through to the blastocyst stage; or

embryo transfer

medical practitioner

 

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

EmbryoGen

(Product No. 1203)

fertilisation and culture until the 2-8 cell stage; or

embryo transfer at day 2 or 3

medical practitioner

 

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

medical practitioner

 

13

EmbryoGen  V2

(Product No. 1204)

culture of human embryos until the 2-8 cell stage; or

embryo transfer at day 2 or 3

medical practitioner

 

14

Endotine Forehead

for use in subperiosteal browplasty surgery

medical practitioner

 

15

Endotine Midface

for use in subperiosteal midface suspension surgery

medical practitioner

 

16

Geistlich Fibro-Gide – Geistlich Pharma

dental filling material

dental practitioner

 

17

GM508 CultActive

for investigation of fertilization failure after previous ICSI-cycles

medical practitioner

 

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

medical practitioner

 

22

Matriderm® Acellular Dermal Substitute

for the treatment of all deep dermal defects in combination with a split-thickness skin graft

medical practitioner

 

23

METS Modular Proximal Femur - CoCr Femoral Head – Stanmore Implants (msfmh/cc22-0 - msfmh/cc32+8)

revision hip arthroplasty

orthopaedic 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 – Durasel 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

 

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

 

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

 


 

Schedule 2—Repeals

Note:       See section 6.

Therapeutic Goods (Authorised Supply of Specified Medical Devices) Rules March 2018

1  The whole of the instrument

Repeal the instrument.