Document ID: chunk:federal_register_of_legislation:F2019L00972:clause:1_4
Version: federal_register_of_legislation:F2019L00972
Segment Type: clause
Provision Reference: sch 1 cl 4
Character Range: 1551–2668

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.