{"id":"F2020L01174","name":"Therapeutic Goods (Medical Devices—Authorised Supply) Rules 2020","slug":"therapeutic-goods-medical-devices-authorised-supply-rules-2020","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"repealed","isInForce":false,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":113578,"registerId":"commonwealth-F2020L01174-current","compilationNumber":null,"startDate":"2026-04-03","status":"Repealed","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Name","content":"#### 1 Name\n\n This instrument is the Therapeutic Goods (Medical Devices—Authorised Supply) Rules 2020.","sortOrder":0},{"sectionNumber":"3","sectionType":"section","heading":"Authority","content":"#### 3 Authority\n\n This instrument is made under subsection 41HC(6) of the Therapeutic Goods Act 1989.","sortOrder":1},{"sectionNumber":"4","sectionType":"section","heading":"Definitions","content":"#### 4 Definitions\n\n> Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:\n\n (a) health practitioner;\n (b) included in the Register;\n (c) medical device;\n (d) Register;\n (e) sponsor; and\n (f) supply.\n In this instrument:\n\n> Act means the Therapeutic Goods Act 1989.\n\n> 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.\n\n> Note: The SAS Guidance is published at www.tga.gov.au.\n\n> Therapeutic Goods Administration has the same meaning as in the Therapeutic Goods Regulations 1990.","sortOrder":2},{"sectionNumber":"5","sectionType":"section","heading":"Authorisation","content":"#### 5 Authorisation\n\n Supply by a specified health practitioner\n (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:\n (a) the kind of medical device is specified in column 2 of that item; and\n (b) the supply is for the purpose specified in column 3 of that item; and\n (c) the conditions specified in subsection (2) are satisfied.\n (2) The health practitioner must:\n (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\n (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\n (c) supply the kind of medical device in accordance with good medical practice; and\n (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\n (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.\n Supply to a patient of a specified health practitioner\n (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:\n (a) the kind of medical device is specified in column 2 of that item; and\n (b) the supply is requested by the treating practitioner; and\n (c) the supply is for the purpose specified in column 3 of that item; and\n (d) the conditions specified in subsection (4) are satisfied.\n (4) The health practitioner supplying the medical device must:\n (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\n (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.\n\nSchedule 1—Medical devices authorised for supply\n\nNote: See section 5.\n\n```html\n

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

\n```","sortOrder":3}],"analysis":{"kimi_summary":{"_metrics":{"model":"kimi-k2.5","source":"moonshot-realtime","completionTokens":1775},"content_quality":"ok","complexity_score":3,"scope_assessment":{"changed":false,"description":"The instrument remains focused on its original purpose of authorising supply of specific unregistered medical devices under the Special Access Scheme. The scope has not expanded beyond the specific products and practitioner categories listed in the Schedule."},"complexity_factors":["Detailed product-specific schedule containing 37 items with precise manufacturer model numbers and catalogue codes","Multiple specialist practitioner categories with device-specific authorizations","Dual supply pathways (direct vs. requested) with differing notification obligations","Incorporation by reference of external SAS Guidance document for reporting procedures"],"plain_english_summary":"This instrument creates a Special Access Scheme allowing 37 specified medical devices not on the ARTG to be supplied for use by certain specialists (orthopaedic, obstetrics/gynaecology for IVF, dental, general/plastic/cardiothoracic surgeons). It enables access to particular implants and IVF/dental equipment for patients when approved alternatives aren’t available. Strict conditions apply: written informed consent, adherence to good medical practice, and mandatory reporting of adverse events or defects to the TGA and sponsor."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-medical-devices-authorised-supply-rules-2020","history":"/api/acts/therapeutic-goods-medical-devices-authorised-supply-rules-2020/history","analysis":"/api/acts/therapeutic-goods-medical-devices-authorised-supply-rules-2020/analysis","conflicts":"/api/acts/therapeutic-goods-medical-devices-authorised-supply-rules-2020/conflicts","importantCases":"/api/acts/therapeutic-goods-medical-devices-authorised-supply-rules-2020/important-cases","documents":"/api/acts/therapeutic-goods-medical-devices-authorised-supply-rules-2020/documents"}}