Federal Register of Legislation - Australian Government

Primary content

Rules/Other as made
These rules authorise the supply of specified kinds of medical devices by specified classes of health practitioners.
Administered by: Health
Registered 27 Mar 2018
Tabling HistoryDate
Tabled HR28-Mar-2018
Tabled Senate08-May-2018

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

Therapeutic Goods Act 1989

I, LARRY KELLY, a delegate of the Minister for Health for the purposes of subsection 41HC(6) of the Therapeutic Goods Act 1989, revoke the Therapeutic Goods (Authorised Supply of Specified Medical Devices) Rules September 2017 that was registered on 29 September 2017, and make the following Rules.

Dated 20 March 2018

(Signed by)

 

LARRY KELLY

Delegate of the Minister for Health


1              Name

                These Rules are the Therapeutic Goods (Authorised Supply of Specified Medical Devices) Rules March 2018.

2              Commencement

                These Rules commence the day after they are registered.

3              Authority

                These Rules are made under subsection 41HC(6) of the Therapeutic Goods Act 1989.

4              Authorisation to supply medical devices

         (1)   A health practitioner of the class specified in column 3 in an item in table 1 is authorised to supply a medical device of the kind specified in column 1 in the item to a person if:

(a)     the person is a patient of the health practitioner; and

(b)     the supply is for the purpose specified in column 2 in the item; and

(c)     the following conditions are satisfied:

(i)      the health practitioner must inform the patient, or a parent or guardian of the patient, that the medical device is not included in the Register;

(ii)     the health practitioner must ensure that the medical device is supplied only after receiving informed consent from the patient, or a parent or guardian of the patient;

(iii)    the health practitioner must ensure that the medical device is supplied in accordance with good medical practice;

(iv)    if the health practitioner becomes aware that the patient has suffered an adverse event in relation to the medical device, the health practitioner must notify the Therapeutic Goods Administration, and the sponsor of the medical device, about the adverse event, in accordance with subsection (3);

(v)     if the health practitioner becomes aware of any defect in the medical device, the health practitioner must notify the Therapeutic Goods Administration, and the sponsor of the medical device, about the defect, in accordance with subsection (3).

         (2)   A health practitioner is authorised to supply a medical device of the kind specified in column 1 in an item in table 1 to a person if:

(a)     the person is a patient of another health practitioner (the treating practitioner); and

(b)     the treating practitioner is a health practitioner of the class specified in column 3 in the item; and

(c)     the supply is requested by the treating practitioner; and

(d)     the supply is for the purpose specified in column 2 in the item; and

(e)     the following conditions are satisfied:

(i)      if the health practitioner supplying the medical device becomes aware that the patient has suffered an adverse event in relation to the medical device, the health practitioner must notify the Therapeutic Goods Administration, and the sponsor of the medical device, about the adverse event, in accordance with subsection (3);

(ii)     if the health practitioner supplying the medical device becomes aware of any defect in the medical device, the health practitioner must notify the Therapeutic Goods Administration, and the sponsor of the medical device, about the defect, in accordance with subsection (3).

(3)   For the purposes of subparagraphs (1)(f)(iv) and (v) and (2)(h)(i) and (ii), notification must be in accordance with the reporting guidelines set out in the document titled Special Access Scheme Guidance for health practitioners and sponsors, version 1.1, published by the Therapeutic Goods Administration in September 2017,

Table 1:    Authorised supply of medical devices

 

 

Item

Column 1

Kind of medical device

Column 2

Purpose

Column 3

Authorised health practitioner

1

Biodesign Enterocutaneous Fistula Plug

For repair of enterocutaneous fistulae.

Medical practitioner

2

BlastGen
(Product No. 1205)

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

Embryo transfer.

Medical practitioner 

3

CollaCote Dressing

For haemostasis or to protect the wound surface during dental procedures.

Dental practitioner 

4

CollaPlug Absorbable Collagen Wound Dressing

For haemostasis or to protect the wound surface during dental procedures.

 

Dental practitioner 

5

CollaTape Absorbable Collagen

For haemostasis or to protect the wound surface during dental procedures.

Dental practitioner 

6

EmbryoGen

(Product No. 1203)

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

Embryo transfer at day 2 or 3.

Medical practitioner 

7

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 

8

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

9

Endotine Forehead

For use in subperiosteal browplasty surgery.

Medical practitioner

10

Endotine Midface

For use in subperiosteal midface suspension surgery.

Medical practitioner

11

GM508 CultActive

For investigation of fertilization failure after previous ICSI-cycles.

Medical practitioner

12

Ilex Skin Protectant

For use on a variety of dermal wounds and stomal irritations as a topical skin barrier.

Medical practitioner; Nurse practitioner

13

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

14

Matriderm® Acellular Dermal Substitute

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

Medical practitioner

15

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

16

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

17

Quintip Individual Skin Test System

For allergy skin testing using puncture to apply the test extract.

Medical practitioner

18

Vicryl tape V152G

For the approximation of parenchymal tissue; or

For reconstruction of the collateral ligaments of the knee.

Medical practitioner