{"id":"F2022L01711","name":"Therapeutic Goods (Medical Devices—Authorised Supply) Rules 2022","slug":"therapeutic-goods-medical-devices-authorised-supply-rules-2022","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":102994,"registerId":"commonwealth-F2022L01711-current","compilationNumber":null,"startDate":"2026-04-03","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Name","content":"#### 1 Name\n\nThis instrument is the Therapeutic Goods (Medical Devices—Authorised Supply) Rules 2022.","sortOrder":0},{"sectionNumber":"3","sectionType":"section","heading":"Authority","content":"#### 3 Authority\n\nThis 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\nNote: 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\n(b) included in the Register;\n\n(c) medical device;\n\n(d) Register;\n\n(e) sponsor;\n\n(f) supply.\n\nIn this instrument:\n\nAct means the Therapeutic Goods Act 1989.\n\n> adverse event means an adverse event that occurs in relation to a person in Australia following use of a medical device that led, or might have led, to the death of, a serious injury to, or serious deterioration in the health of, that person.\n\n> Note: An adverse event may not necessarily have a causal relationship with the administration or use of the medical device.\n\ndefect, in relation to a medical device, means any of the following that might lead, or might have led, to the death of, a serious injury to, or serious deterioration in the health of, a person:\n\n (a) any malfunction or deterioration in the characteristics or performance of the medical device;\n (b) any inadequacy in the design, production, labelling, instructions for use or advertising materials of the medical device.\n\nTherapeutic 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\nSupply by a specified health practitioner\n\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\n(a) the kind of medical device is specified in column 2 of that item; and\n\n(b) the supply is for the purpose specified in column 3 of that item; and\n\n(c) the conditions specified in subsection (2) are satisfied.\n\n(2) The health practitioner must:\n\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\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\n(c) supply the kind of medical device in accordance with good medical practice; and\n\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 within 15 days of becoming aware of the adverse event; and\n\n(e) if the health practitioner becomes aware of a defect in the kind of medical device—notify the Therapeutic Goods Administration within 15 days of becoming aware of the defect.\n\nSupply to a patient of a specified health practitioner\n\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\n(a) the kind of medical device is specified in column 2 of that item; and\n\n(b) the supply is requested by the treating practitioner; and\n\n(c) the supply is for the purpose specified in column 3 of that item; and\n\n(d) the conditions specified in subsection (4) are satisfied.\n\n(4) The health practitioner supplying the medical device must:\n\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 within 15 days of becoming aware of the adverse event; and\n\n(b) if the health practitioner becomes aware of a defect in the kind of medical device—notify the Therapeutic Goods Administration within 15 days of becoming aware of the defect.\n\n \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

4

AltiVate Reverse Shoulder system – DJO Global

for arthroplasty of the shoulder

orthopaedic surgeon

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

Duraloc Acetabular Cup System – Hip Insert/Liner – Johnson & Johnson t/a DePuy Synthes

revision hip arthroplasty

orthopaedic surgeon

15

Endotine Forehead

for use in subperiosteal browplasty surgery

ophthalmologist;

plastic surgeon

16

Endotine Midface

for use in subperiosteal midface suspension surgery

plastic surgeon

19

Insall/Burstein II Modular Knee System - Posterior Stabilised Tibial Articular Surface – Zimmer Biomet (00522003101 – 00522003506)

revision knee arthroplasty

orthopaedic surgeon

21

MG II Total Knee System - Tibial Articular Surface – Zimmer Biomet (00511002309 – 00511005323)

revision knee arthroplasty

orthopaedic surgeon

22

M/G Unicompartmental Knee System - Tibial Articulating Surface – Zimmer Biomet

(00578804008 – 00578808014)

revision knee arthroplasty

orthopaedic surgeon

23

Natural Knee II System – Durasul PE Congruent Tibial Insert – Zimmer Biomet (620108809 – 620110916)

revision knee arthroplasty

orthopaedic surgeon

24

NexGen Complete Knee Solution – Cruciate Retaining (CR) Articular Surface – Zimmer Biomet (00597002009 – 00597005020)

revision knee arthroplasty

orthopaedic surgeon

25

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

26

NexGen Complete Knee Solution Mobile Bearing Knee System - Articular Surface – Zimmer Biomet (00594203109 – 00594207217)

revision knee arthroplasty

orthopaedic surgeon

27

NexGen Complete Knee Solution – Posterior Stabilized (PS) Articular Surface – Zimmer Biomet (00598202010 – 00598205123)

revision knee arthroplasty

orthopaedic surgeon

28

Omnifit Crossfire Series II Cup Insert – Stryker Orthopaedics (2041C2240 - 2041C3274)

revision hip arthroplasty

orthopaedic surgeon

28A

Origin Stem, Cox Vara, Sizes 9 to 18 – Signature Orthopaedics

hip arthroplasty

orthopaedic surgeon

29

Primetech Piezo Micro Manipulator and microinjection pipettes

in vitro fertilisation

obstetrics and gynaecology specialist

30

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

31

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

32

Quintip Individual Skin Test System

for allergy skin testing using puncture to apply the test extract

medical practitioner

33

Reflection Ceramic Acetabular System - Reflection Biolox Forte Ceramic Acetabular Liner – Smith & Nephew (71338146 – 71338456)

revision hip arthroplasty

orthopaedic surgeon

34

Regeneten Bioinductive Implant – Bone Anchors with Arthroscopic Delivery System

rotator cuff surgery

orthopaedic surgeon

35

SeleXys Hip System – Inlay Bionit2 – Mathys Orthopaedics (55462803 – 55463612)

revision hip arthroplasty

orthopaedic surgeon

35A

Taurolock-U25.000 ((cyclo)-taurolidine, citrate (4%) and urokinase (25.000 IU))

for use as a catheter lock solution, instilled into a port or a silicone or polyurethane catheter‑based device at the termination of a treatment, and is withdrawn prior to subsequent treatments

nephrology physician

36

Trilogy AB Alternate Bearing Shell Insert – Zimmer Biomet (00640502601 – 00640503206 AND 00641502802 – 00641503206)

revision hip arthroplasty

orthopaedic surgeon

\n```","sortOrder":3}],"analysis":{"flash_summary":{"complexity_score":4,"scope_assessment":{"changed":false,"description":"Based on the text provided, there is no basis to conclude this instrument changes the legislative scope beyond authorising listed off‑Register devices under specified conditions. The instrument creates a targeted authorisation and associated duties but does not, in this text alone, expand or narrow the Act's scope in a way demonstrably different from its stated authorising power (see s 3 and s 5)."},"complexity_factors":["Device-specific list in Schedule 1: many individually identified products and uses increase administrative detail and limit generalisability.","Differing conditions depending on supply context: supply to own patient requires disclosure, informed consent and good medical practice (s 5(1)–(2)); supply at a treating practitioner's request omits disclosure/consent requirements but retains reporting duties (s 5(3)–(4)).","Mandatory short reporting timelines for adverse events and defects (notify TGA within 15 days) create a time-sensitive compliance burden (s 5(2)(d)–(e), s 5(4)).","Cross-references to the Act and Regulations for key definitions and enforcement (definition references in s 4 and authority under s 3 referencing s 41HC(6) of the Act) require users to consult multiple instruments.","Defined technical terms (adverse event; defect) with clinical risk thresholds introduce legal interpretation tasks for practitioners (s 4 definitions).","Operational enforcement and recordkeeping responsibilities fall on individual practitioners and indirectly on sponsors/TGA to process notifications, creating implementation and resourcing considerations."],"plain_english_summary":"This instrument authorises named health practitioners to supply specific medical devices that are not included on the Therapeutic Goods Register, subject to conditions. Practitioners must inform patients, obtain informed consent, follow good medical practice, and notify the Therapeutic Goods Administration of any adverse event or defect within 15 days. The Schedule lists the exact devices and the practitioner types allowed to supply them. It affects practitioners who supply off‑Register devices, patients receiving them, and the TGA that receives mandatory reports."},"flash_summary_failed":{"failed":true,"reason":"A positive credit balance is required for all requests, including BYOK, so fallback providers remain available. Add credits at https://vercel.com/d?to=%2F%5Bteam%5D%2F%7E%2Fai%3Fmodal%3Dtop-up to continue.","source":"analysis-cron"},"kimi_summary":{"content_quality":"ok","complexity_score":3,"scope_assessment":{"changed":false,"description":"This is a standard delegated legislative instrument made under section 41HC(6) of the Therapeutic Goods Act 1989. Its purpose is specifically to authorise supply of unregistered medical devices by specified health practitioners — exactly what the enabling provision contemplates. The scope remains tightly confined to creating a permissions framework with attached conditions."},"complexity_factors":["Short instrument: only 5 operative sections plus a schedule","Straightforward tabular structure in Schedule 1 with 4 clear columns (item number, device, purpose, authorised practitioner)","Only 6 defined terms in section 4, with most definitions imported by reference from the parent Act","Simple conditional logic: two parallel authorisation pathways (practitioner to their own patient, or practitioner supplying at another practitioner's request)","No nested exceptions or complex cross-referencing — conditions are listed plainly in subsections (2) and (4)","Schedule 1 contains 36 specific device entries but these are data rows rather than legal complexity"],"plain_english_summary":"This law creates a limited permission system letting specified health practitioners use 36 named medical devices that aren’t on Australia’s official register. It affects patients needing certain implants or procedures and the listed specialists who may supply those devices, while the TGA receives safety reports. \n\nKey safeguards require disclosure that the device is unregistered, informed consent, adherence to good medical practice, and mandatory reporting to the TGA of serious harm, death or device malfunction within 15 days."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-medical-devices-authorised-supply-rules-2022","history":"/api/acts/therapeutic-goods-medical-devices-authorised-supply-rules-2022/history","analysis":"/api/acts/therapeutic-goods-medical-devices-authorised-supply-rules-2022/analysis","conflicts":"/api/acts/therapeutic-goods-medical-devices-authorised-supply-rules-2022/conflicts","importantCases":"/api/acts/therapeutic-goods-medical-devices-authorised-supply-rules-2022/important-cases","documents":"/api/acts/therapeutic-goods-medical-devices-authorised-supply-rules-2022/documents"}}