, in relation to a medical device covered by paragraph 41BD(1)(a), (aa) or (ab), means a thing that the manufacturer of the thing specifically intended to be used together with the device to enable the device to be used as the manufacturer of the device intended.

has the meaning given by section 42U.

, in relation to therapeutic goods, includes make any statement, pictorial representation or design that is intended, whether directly or indirectly, to promote the use or supply of the goods, including where the statement, pictorial representation or design:

means:

has the meaning given by subsection 3AB(1).

has the meaning given by subsection 3AB(2).

means an applicant for approval of the use of a restricted representation in an advertisement about therapeutic goods.

means a fee payable under subsection 41LA(3).

, in relation to a restricted representation, means the person to whom notice of approval of the use of the restricted representation was given.

means:

means an Australian corporation that is the subject of a conformity assessment body determination made under the regulations.

means a certificate that is issued by an Australian conformity assessment body and that is of a kind mentioned in section 41FIA.

means the Agreement on Mutual Recognition in Relation to Conformity Assessment, Certificates And Markings between the Government of Australia and the Government of the United Kingdom of Great Britain and Northern Ireland, as in force from time to time.

means a quantity of a product that is:

, in relation to therapeutic goods, means the quantity and characteristics of microorganisms present in the goods or to which the goods may be exposed in a manufacturing environment.

has the meaning given by section 32A.

of a biological means:

means the edition of the publication of that name, including any additions or amendments, that was in effect for the purposes of this Act immediately before the commencement of Schedule 4 to the Therapeutic Goods Amendment (Medical Devices and Other Measures) Act 2009 and, if additions or amendme

, when used in relation to an Australian conformity assessment body, means activities that consist of, or relate to, the issue of certificates as mentioned in section 41FIA.

has the meaning given by section 42YA.