Therapeutic Goods (Medical Devices—Authorised Supply) Rules 2020

made under subsection 41HC(6) of the

Therapeutic Goods Act 1989

Compilation No. 1

Compilation date:                             11 February 2022

Includes amendments up to:           F2022L00123

About this compilation

This compilation

This is a compilation of the Therapeutic Goods (Medical Devices—Authorised Supply) Rules 2020 that shows the text of the law as amended and in force on 11 February 2022 (the compilation date).

The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of provisions of the compiled law.

Uncommenced amendments

The effect of uncommenced amendments is not shown in the text of the compiled law. Any uncommenced amendments affecting the law are accessible on the Legislation Register (www.legislation.gov.au). The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. For more information on any uncommenced amendments, see the series page on the Legislation Register for the compiled law.

Application, saving and transitional provisions for provisions and amendments

If the operation of a provision or amendment of the compiled law is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes.

Modifications

If the compiled law is modified by another law, the compiled law operates as modified but the modification does not amend the text of the law. Accordingly, this compilation does not show the text of the compiled law as modified. For more information on any modifications, see the series page on the Legislation Register for the compiled law.

Self‑repealing provisions

If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.

Contents

1  Name........................................................................................................................................ 1

3  Authority.................................................................................................................................. 1

4  Definitions................................................................................................................................ 1

5  Authorisation............................................................................................................................ 1

Schedule 1—Medical devices authorised for supply                                                  3

Endnotes                                                                                                                        7

Endnote 1—About the endnotes                                                                              7

Endnote 2—Abbreviation key                                                                                 8

Endnote 3—Legislation history                                                                              9

Endnote 4—Amendment history                                                                           10

1  Name

                   This instrument is the Therapeutic Goods (Medical Devices—Authorised Supply) Rules 2020.

3  Authority

                   This instrument is made under subsection 41HC(6) of the Therapeutic Goods Act 1989.

4  Definitions

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.

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.

Schedule 1—Medical devices authorised for supply

Note:       See section 5.

Endnotes

Endnote 1—About the endnotes

The endnotes provide information about this compilation and the compiled law.

The following endnotes are included in every compilation:

Endnote 1—About the endnotes

Endnote 2—Abbreviation key

Endnote 3—Legislation history

Endnote 4—Amendment history

Abbreviation key—Endnote 2

The abbreviation key sets out abbreviations that may be used in the endnotes.

Legislation history and amendment history—Endnotes 3 and 4

Amending laws are annotated in the legislation history and amendment history.

The legislation history in endnote 3 provides information about each law that has amended (or will amend) the compiled law. The information includes commencement details for amending laws and details of any application, saving or transitional provisions that are not included in this compilation.

The amendment history in endnote 4 provides information about amendments at the provision (generally section or equivalent) level. It also includes information about any provision of the compiled law that has been repealed in accordance with a provision of the law.

Misdescribed amendments

A misdescribed amendment is an amendment that does not accurately describe the amendment to be made. If, despite the misdescription, the amendment can be given effect as intended, the amendment is incorporated into the compiled law and the abbreviation “(md)” added to the details of the amendment included in the amendment history.

If a misdescribed amendment cannot be given effect as intended, the abbreviation “(md not incorp)” is added to the details of the amendment included in the amendment history.

Endnote 2—Abbreviation key

Endnote 3—Legislation history

Endnote 4—Amendment history