Document ID: chunk:federal_register_of_legislation:F2024C01102:reg:5
Version: federal_register_of_legislation:F2024C01102
Segment Type: reg
Provision Reference: reg 5
Character Range: 3234–6030

5  Authorisation

       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.