Therapeutic Goods (Australian Breast Device Registry) Specification 2019 (Cth)

Therapeutic Goods (Australian Breast Device Registry) Specification 2019

I, Ben Noyen, as delegate of the Minister for Health, make the following specification.

Dated 26 July 2019

Ben Noyen Acting First Assistant Secretary Medical Devices and Product Quality Division Health Products Regulation Group Department of Health

Contents 1 Name 2 Commencement 3 Authority 4 Definitions 5 Release of therapeutic goods information Schedule 1—Therapeutic goods information

1 Name This instrument is the Therapeutic Goods (Australian Breast Device Registry) Specification 2019.

2 Commencement (1) Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

Commencement information Column 1 Column 2 Column 3 Provisions Commencement Date/Details 1. The whole of this instrument The day after this instrument is registered.

Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument. (2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

3 Authority This instrument is made under subsection 61(5AB) of the Therapeutic Goods Act 1989.

4 Definitions

Note: A number of expressions used in this instrument are defined in section 3 of the Act, including the following: (a) device number; (b) manufacturer; (c) Register; (d) Secretary; and (e) therapeutic goods.

In this instrument: ABDR means the Australian Breast Device Registry administered by Monash University (ABN 12 377 614 012). Act means the Therapeutic Goods Act 1989. breast device means one of the following medical devices, or kinds of medical device: (a) breast implant; (b) acellular dermal matrix; (c) tissue expander. therapeutic goods information has the meaning given by subsection 61(1) of the Act.