Therapeutic Goods (Breast Implants Information) Specification 2019 (Cth)

Therapeutic Goods (Breast Implants Information) Specification 2019

I, John Skerritt, as delegate of the Minister for Health, make the following specification.

Dated 9 July 2019

Adjunct Professor John Skerritt Deputy Secretary Health Products Regulation Group Department of Health

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

1 Name This instrument is the Therapeutic Goods (Breast Implants Information) 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Note: This table relates only to the provisions of this instrument as originally made.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(5D) 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, of a medical device; (c) medical device; (d) Register; (e) sponsor; and (f) therapeutic goods. In this instrument: Act means Therapeutic Goods Act 1989. breast implant device means a medical device which is intended for the purpose of implantation as a breast implant, mammary implant or tissue expander (however described). relevant regulatory action means one or more of the following actions by a delegate of the Secretary: (a) giving notice of a proposal to suspend a kind of medical device from the Register under Part 4-6 of the Act; (b) giving notice of a proposal to cancel the entry of a kind of medical device from the Register under Part 4-6 of the Act; (c) the imposition of new conditions on including a kind of device in the Register under section 41FP of the Act. therapeutic goods information has the meaning given by subsection 61(1) of the Act.