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This instrument is the Therapeutic Goods (Medical Devices—Authorised Supply) Rules 2020.
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Commonwealth legislation
This Act has been repealed and is no longer in force. It is retained for historical reference.
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.
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Direct links to the current provisions in Therapeutic Goods (Medical Devices—Authorised Supply) Rules 2020.
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 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.
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.
<table cellspacing="0" cellpadding="0" style="width:100%; border-collapse:collapse"><thead><tr style="height:2.85pt"><td colspan="5" style="border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading" style="line-height:normal"><span>Specified therapeutic goods</span></p></td></tr><tr style="height:2.85pt"><td style="width:12.88%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading" style="line-height:normal"><span>Column 1</span></p></td><td style="width:28.28%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading" style="line-height:normal"><span>Column 2</span></p></td><td style="width:34.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading" style="line-height:normal"><span>Column 3</span></p></td><td style="width:23.52%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading" style="line-height:normal"><span>Column 4</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:2.85pt"><td style="width:12.88%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading" style="line-height:normal"><span>Item</span></p></td><td style="width:28.28%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading" style="line-height:normal"><span>Kind of medical device</span></p></td><td style="width:34.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading" style="line-height:normal"><span>Purpose</span></p></td><td style="width:23.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading" style="line-height:normal"><span>Health practitioner</span></p></td><td style="vertical-align:top"></td></tr></thead><tbody><tr style="height:1pt"><td style="width:12.88%; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>1</span></p></td><td style="width:28.28%; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>14/16 Taper Femoral Heads – Oxinium – Smith & Nephew (71342280 – 71342368)</span></p></td><td style="width:34.9%; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>revision hip arthroplasty</span></p></td><td style="width:23.52%; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>orthopaedic surgeon</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>2</span></p></td><td style="width:28.28%; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Aequalis PerForm Plus Reversed Glenoid – Wright Medical</span></p></td><td style="width:34.9%; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>for arthroplasty of the shoulder</span></p></td><td style="width:23.52%; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>orthopaedic surgeon</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>3</span></p></td><td style="width:28.28%; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Aequalis PerForm Reversed Glenoid – Wright Medical</span></p></td><td style="width:34.9%; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>for arthroplasty of the shoulder</span></p></td><td style="width:23.52%; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>orthopaedic surgeon</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>4A</span></p></td><td style="width:28.28%; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>AltiVate Reverse Shoulder system – DJO Global</span></p></td><td style="width:34.9%; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>for arthroplasty of the shoulder</span></p></td><td style="width:23.52%; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>orthopaedic surgeon</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>5</span></p></td><td style="width:28.28%; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Biodesign Enterocutaneous Fistula Plug</span></p></td><td style="width:34.9%; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>for repair of enterocutaneous fistulae</span></p></td><td style="width:23.52%; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>general surgeon</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>6</span></p></td><td style="width:28.28%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>BlastGen</span><br><span>(Product No. 1205)</span></p></td><td style="width:34.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>culture of embryos from the 4-8 cell stage through to the blastocyst stage; or</span></p><p class="Tabletext"><span>embryo transfer</span></p></td><td style="width:23.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>obstetrics and gynaecology specialist</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>7</span></p></td><td style="width:28.28%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>CelGro Type I/III collagen scaffold – Orthocell</span></p><p class="Tabletext"><span></span></p></td><td style="width:34.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>articular cartilage repair: collagen scaffold for use with autologous chondrocyte implantation (ACI) to knee (including patellofemoral) and ankle joint; or</span></p><p class="Tabletext"><span>augmentation of rotator cuff tendon repair</span></p></td><td style="width:23.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>orthopaedic surgeon</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>8</span></p></td><td style="width:28.28%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>CollaCote Dressing</span></p></td><td style="width:34.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>for haemostasis or to protect the wound surface during dental procedures</span></p></td><td style="width:23.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>dental practitioner</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>9</span></p></td><td style="width:28.28%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>CollaPlug Absorbable Collagen Wound Dressing</span></p></td><td style="width:34.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>for haemostasis or to protect the wound surface during dental procedures</span></p></td><td style="width:23.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>dental practitioner</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>10</span></p></td><td style="width:28.28%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>CollaTape Absorbable Collagen</span></p></td><td style="width:34.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>for haemostasis or to protect the wound surface during dental procedures</span></p></td><td style="width:23.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>dental practitioner</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>10A</span></p></td><td style="width:28.28%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Duraloc Acetabular Cup System – Hip Insert/Liner – Johnson & Johnson t/a DePuy Synthes</span></p></td><td style="width:34.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>revision hip arthroplasty</span></p></td><td style="width:23.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>orthopaedic surgeon</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>11</span></p></td><td style="width:28.28%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>EmbryoGen</span></p><p class="Tabletext"><span>(Product No. 1203)</span></p></td><td style="width:34.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>fertilisation and culture until the 2-8 cell stage; or</span></p><p class="Tabletext"><span>embryo transfer at day 2 or 3</span></p></td><td style="width:23.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>obstetrics and gynaecology specialist</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>12</span></p></td><td style="width:28.28%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>EmbryoGen & BlastGen</span></p><p class="Tabletext"><span>(Product No. 1206)</span></p></td><td style="width:34.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>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</span></p><p class="Tabletext"><span>embryo transfer</span></p></td><td style="width:23.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>obstetrics and gynaecology specialist</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>13</span></p></td><td style="width:28.28%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>EmbryoGen</span><span> </span><span>V2</span></p><p class="Tabletext"><span>(Product No. 1204)</span></p></td><td style="width:34.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>culture of human embryos until the 2-8 cell stage; or</span></p><p class="Tabletext"><span>embryo transfer at day 2 or 3</span></p></td><td style="width:23.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>obstetrics and gynaecology specialist</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>14</span></p></td><td style="width:28.28%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Endotine Forehead</span></p></td><td style="width:34.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>for use in subperiosteal browplasty surgery</span></p></td><td style="width:23.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>plastic surgeon</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>15</span></p></td><td style="width:28.28%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Endotine Midface</span></p></td><td style="width:34.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>for use in subperiosteal midface suspension surgery</span></p></td><td style="width:23.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>plastic surgeon</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>16</span></p></td><td style="width:28.28%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Geistlich Fibro-Gide – Geistlich Pharma</span></p></td><td style="width:34.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>dental filling material</span></p></td><td style="width:23.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>dental practitioner</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>17</span></p></td><td style="width:28.28%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>GM508 CultActive</span></p></td><td style="width:34.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>for investigation of fertilization failure after previous ICSI-cycles</span></p></td><td style="width:23.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>obstetrics and gynaecology specialist</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>18</span></p></td><td style="width:28.28%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Ilex Skin Protectant</span></p></td><td style="width:34.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>for use on a variety of dermal wounds and stomal irritations as a topical skin barrier</span></p></td><td style="width:23.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>medical practitioner; nurse practitioner</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>19</span></p></td><td style="width:28.28%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Insall/Burstein II Modular Knee System - Posterior Stabilised Tibial Articular Surface – Zimmer Biomet (00522003101 – 00522003506)</span></p></td><td style="width:34.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>revision knee arthroplasty</span></p></td><td style="width:23.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>orthopaedic surgeon</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>20</span></p></td><td style="width:28.28%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Journey II Bi-Cruciate Stabilized (BCS) Total Knee System - Articular Insert – Smith & Nephew (74027211 – 74027288)</span></p></td><td style="width:34.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>revision knee arthroplasty</span></p></td><td style="width:23.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>orthopaedic surgeon</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>21</span></p></td><td style="width:28.28%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Jupiter Sternal Protection Device</span></p></td><td style="width:34.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>for use following median sternotomy incisions to add a protective layer over the entire cut surfaces of the sternal bone</span></p></td><td style="width:23.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>cardiothoracic surgeon</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>24</span></p></td><td style="width:28.28%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>MG II Total Knee System - Tibial Articular Surface – Zimmer Biomet (00511002309 – 00511005323)</span></p></td><td style="width:34.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>revision knee arthroplasty</span></p></td><td style="width:23.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>orthopaedic surgeon</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>25</span></p></td><td style="width:28.28%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>M/G Unicompartmental Knee System - Tibial Articulating Surface – Zimmer Biomet</span></p><p class="Tabletext"><span>(00578804008 – 00578808014)</span></p></td><td style="width:34.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>revision knee arthroplasty</span></p></td><td style="width:23.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>orthopaedic surgeon</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>26</span></p></td><td style="width:28.28%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Natural Knee II System – Durasul PE Congruent Tibial Insert – Zimmer Biomet (620108809 – 620110916)</span></p></td><td style="width:34.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>revision knee arthroplasty</span></p></td><td style="width:23.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>orthopaedic surgeon</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>27</span></p></td><td style="width:28.28%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>NexGen Complete Knee Solution – Cruciate Retaining (CR) Articular Surface – Zimmer Biomet (00597002009 – 00597005020)</span></p></td><td style="width:34.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>revision knee arthroplasty</span></p></td><td style="width:23.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>orthopaedic surgeon</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>28</span></p></td><td style="width:28.28%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>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)</span></p></td><td style="width:34.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>revision knee arthroplasty</span></p></td><td style="width:23.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>orthopaedic surgeon</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>29</span></p></td><td style="width:28.28%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>NexGen Complete Knee Solution Mobile Bearing Knee System - Articular Surface – Zimmer Biomet (00594203109 – 00594207217)</span></p></td><td style="width:34.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>revision knee arthroplasty</span></p></td><td style="width:23.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>orthopaedic surgeon</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>30</span></p></td><td style="width:28.28%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>NexGen Complete Knee Solution – Posterior Stabilized (PS) Articular Surface – Zimmer Biomet (00598202010 – 00598205123)</span></p></td><td style="width:34.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>revision knee arthroplasty</span></p></td><td style="width:23.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>orthopaedic surgeon</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>31</span></p></td><td style="width:28.28%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Omnifit Crossfire Series II Cup Insert – Stryker Orthopaedics (2041C2240 - 2041C3274)</span></p></td><td style="width:34.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>revision hip arthroplasty</span></p></td><td style="width:23.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>orthopaedic surgeon</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>31A</span></p></td><td style="width:28.28%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Primetech Piezo Micro Manipulator and microinjection pipettes</span></p></td><td style="width:34.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>in vitro fertilisation</span></p></td><td style="width:23.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>obstetrics and gynaecology specialist</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>32</span></p></td><td style="width:28.28%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Pro Osteon®</span><span> </span><span>Bone Graft Substitute 200R</span></p></td><td style="width:34.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>for use as a bone graft substitute only for bony voids or gaps that are not intrinsic to the stability of the bony structure</span></p></td><td style="width:23.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>medical practitioner; dental practitioner</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>33</span></p></td><td style="width:28.28%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Pro Osteon®</span><span> </span><span>Bone Graft Substitute 500R</span></p></td><td style="width:34.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>for use as a bone graft substitute only for voids or gaps that are not intrinsic to the stability of the bony structure</span></p></td><td style="width:23.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>medical practitioner</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>34</span></p></td><td style="width:28.28%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Quintip Individual Skin Test System</span></p></td><td style="width:34.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>for allergy skin testing using puncture to apply the test extract</span></p></td><td style="width:23.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>medical practitioner</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>35</span></p></td><td style="width:28.28%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Reflection Ceramic Acetabular System - Reflection Biolox Forte Ceramic Acetabular Liner – Smith & Nephew (71338146 – 71338456)</span></p></td><td style="width:34.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>revision hip arthroplasty</span></p></td><td style="width:23.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>orthopaedic surgeon</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>35A</span></p></td><td style="width:28.28%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Regeneten Bioinductive Implant – Bone Anchors with Anthroscopic Delivery System</span></p></td><td style="width:34.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>rotator cuff surgery</span></p></td><td style="width:23.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>orthopaedic surgeon</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>36</span></p></td><td style="width:28.28%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>SeleXys Hip System – Inlay Bionit2 – Mathys Orthopaedics (55462803 – 55463612)</span></p></td><td style="width:34.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>revision hip arthroplasty</span></p></td><td style="width:23.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>orthopaedic surgeon</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>37</span></p></td><td style="width:28.28%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Trilogy AB Alternate Bearing Shell Insert – Zimmer Biomet (00640502601 – 00640503206 AND 00641502802 – 00641503206)</span></p></td><td style="width:34.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>revision hip arthroplasty</span></p></td><td style="width:23.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>orthopaedic surgeon</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:0pt"><td style="width:53.55pt"></td><td style="width:117.55pt"></td><td style="width:145.05pt"></td><td style="width:97.75pt"></td><td style="width:1.75pt"></td></tr></tbody></table>
Sourced from the Federal Register of Legislation (legislation.gov.au), CC BY 4.0.
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 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.
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.
<table cellspacing="0" cellpadding="0" style="width:100%; border-collapse:collapse"><thead><tr style="height:2.85pt"><td colspan="5" style="border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading" style="line-height:normal"><span>Specified therapeutic goods</span></p></td></tr><tr style="height:2.85pt"><td style="width:12.88%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading" style="line-height:normal"><span>Column 1</span></p></td><td style="width:28.28%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading" style="line-height:normal"><span>Column 2</span></p></td><td style="width:34.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading" style="line-height:normal"><span>Column 3</span></p></td><td style="width:23.52%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading" style="line-height:normal"><span>Column 4</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:2.85pt"><td style="width:12.88%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading" style="line-height:normal"><span>Item</span></p></td><td style="width:28.28%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading" style="line-height:normal"><span>Kind of medical device</span></p></td><td style="width:34.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading" style="line-height:normal"><span>Purpose</span></p></td><td style="width:23.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading" style="line-height:normal"><span>Health practitioner</span></p></td><td style="vertical-align:top"></td></tr></thead><tbody><tr style="height:1pt"><td style="width:12.88%; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>1</span></p></td><td style="width:28.28%; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>14/16 Taper Femoral Heads – Oxinium – Smith & Nephew (71342280 – 71342368)</span></p></td><td style="width:34.9%; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>revision hip arthroplasty</span></p></td><td style="width:23.52%; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>orthopaedic surgeon</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>2</span></p></td><td style="width:28.28%; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Aequalis PerForm Plus Reversed Glenoid – Wright Medical</span></p></td><td style="width:34.9%; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>for arthroplasty of the shoulder</span></p></td><td style="width:23.52%; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>orthopaedic surgeon</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>3</span></p></td><td style="width:28.28%; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Aequalis PerForm Reversed Glenoid – Wright Medical</span></p></td><td style="width:34.9%; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>for arthroplasty of the shoulder</span></p></td><td style="width:23.52%; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>orthopaedic surgeon</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>4A</span></p></td><td style="width:28.28%; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>AltiVate Reverse Shoulder system – DJO Global</span></p></td><td style="width:34.9%; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>for arthroplasty of the shoulder</span></p></td><td style="width:23.52%; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>orthopaedic surgeon</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>5</span></p></td><td style="width:28.28%; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Biodesign Enterocutaneous Fistula Plug</span></p></td><td style="width:34.9%; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>for repair of enterocutaneous fistulae</span></p></td><td style="width:23.52%; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>general surgeon</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>6</span></p></td><td style="width:28.28%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>BlastGen</span><br><span>(Product No. 1205)</span></p></td><td style="width:34.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>culture of embryos from the 4-8 cell stage through to the blastocyst stage; or</span></p><p class="Tabletext"><span>embryo transfer</span></p></td><td style="width:23.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>obstetrics and gynaecology specialist</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>7</span></p></td><td style="width:28.28%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>CelGro Type I/III collagen scaffold – Orthocell</span></p><p class="Tabletext"><span></span></p></td><td style="width:34.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>articular cartilage repair: collagen scaffold for use with autologous chondrocyte implantation (ACI) to knee (including patellofemoral) and ankle joint; or</span></p><p class="Tabletext"><span>augmentation of rotator cuff tendon repair</span></p></td><td style="width:23.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>orthopaedic surgeon</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>8</span></p></td><td style="width:28.28%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>CollaCote Dressing</span></p></td><td style="width:34.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>for haemostasis or to protect the wound surface during dental procedures</span></p></td><td style="width:23.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>dental practitioner</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>9</span></p></td><td style="width:28.28%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>CollaPlug Absorbable Collagen Wound Dressing</span></p></td><td style="width:34.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>for haemostasis or to protect the wound surface during dental procedures</span></p></td><td style="width:23.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>dental practitioner</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>10</span></p></td><td style="width:28.28%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>CollaTape Absorbable Collagen</span></p></td><td style="width:34.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>for haemostasis or to protect the wound surface during dental procedures</span></p></td><td style="width:23.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>dental practitioner</span></p></td><td style="vertical-align:top"></td></tr><tr style="hei
This is an opening excerpt, not the complete document.