Therapeutic Goods (Authorised Supply of Specified Medical Devices) Rules September 2017 (Cth)

Therapeutic Goods (Authorised Supply of Specified Medical Devices) Rules September 2017

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 2017 that was registered on 3 July 2017, and make the following Rules.

Dated 27 September 2017

(Signed by)

LARRY KELLY

Delegate of the Minister for Health

1Name

These Rules are the Therapeutic Goods (Authorised Supply of Specified Medical Devices) Rules September 2017.

2Commencement

These Rules commence the day after they are registered.

3Authority

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

4Authorisation to supply medical devices

1. (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. (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. (3)

   For the purposes of subparagraphs (1)(c)(iv) and (v) and (2)(e)(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	EmbryoGen (Product No: 1203)	EmbryoGen is for fertilisation and culture until the 2-8 cell stage. EmbryoGen can also be used for embryo transfer at day 2 or 3. This product is for IVF treatment of women, whether the cause of infertility is male or female. Recommended for patients who have experienced: • Recurrent clinical and biochemical pregnancy loss • Recurrent implantation failure • Unexplained infertility	Medical practitioner
2	EmbryoGen V2 (Product No: 1204)	EmbryoGen is for culture of human embryos until the 2-8 cell stage. EmbryoGen can also be used for embryo transfer at day 2 or 3.	Medical practitioner
3	BlastGen (Product No: 1205)	BlastGen is for the culture of embryos from the 4-8 cell stage through to the blastocyst stage. BlastGen can also be used for embryo transfer.	Medical practitioner
4	EmbryoGen & BlastGen (Product No: 1206)	Embryogen is suitable for the culture of embryos until the 2-8 cell stage. BlastGen is for the culture of embryos from the 4-8 cell stage through to the blastocyst stage.	Medical practitioner