Commonwealth Consolidated Acts

THERAPEUTIC GOODS ACT 1989 - SECT 41FN

Entry and inspection powers

  (1)   The inclusion of a kind of medical device in the Register is subject to the conditions that the person in relation to whom the kind of device is included in the Register will:

  (a)   allow an authorised person:

  (i)   to enter, at any reasonable time, any premises (including premises outside Australia) at which that person or any other person deals with medical devices of that kind; and

  (ii)   while on those premises, to inspect those premises and medical devices of any kind on those premises and to examine, take measurements of, conduct tests on, require tests to be conducted on or take samples of medical devices of any kind on those premises or any thing on those premises that relates to medical devices of any kind; and

  (iii)   while on those premises, to make any still or moving image or any recording of those premises or any thing on those premises; and

  (b)   if requested to do so by an authorised person, produce to the person such documents relating to devices of the kind included in the Register as the person requires and allow the person to copy the documents.

Delivery of samples

  (2)   The inclusion of a kind of medical device in the Register is subject to a condition that the person in relation to whom the kind of device is included in the Register will deliver a reasonable number of samples of the kind of device if the Secretary so requests:

  (a)   within the period specified in the request; and

  (b)   in accordance with any other requirements specified in the request.

The period specified in the request must include at least 10 working days.

Availability etc. of information

  (3)   The inclusion of a kind of medical device in the Register is subject to conditions that:

  (a)   at all times while the inclusion in the Register has effect, the person in relation to whom the kind of device is included in the Register:

  (i)   has available sufficient information to substantiate compliance with the essential principles; or

  (ii)   has procedures in place, including a written agreement with the manufacturer of the kind of device, to ensure that such information can be obtained from the manufacturer within 20 working days; and

  (b)   at all times while the inclusion in the Register has effect, the person in relation to whom the kind of device is included in the Register:

  (i)   has available sufficient information to substantiate that the conformity assessment procedures have been applied to the kind of medical device or that requirements, comparable to those procedures, have been applied to the kind of medical device to the satisfaction of an overseas regulator; or

  (ii)   has procedures in place, including a written agreement with the manufacturer of the kind of device, to ensure that such information can be obtained from the manufacturer within 20 working days; and

  (ba)   at all times while the inclusion in the Register has effect, the person in relation to whom the kind of device is included in the Register:

  (i)   has available information relating to changes to the kind of medical device, the product range or quality management system by the manufacturer of the kind of device; or

  (ii)   has procedures in place, including a written agreement with the manufacturer of the kind of device, to ensure that such information can be obtained from the manufacturer within 20 working days; and

  (c)   at any time while the inclusion in the Register has effect, the person in relation to whom the kind of device is included in the Register will, if asked to do so by the Secretary, give the information to the Secretary; and

  (d)   the person in relation to whom the kind of device is included in the Register will give information of a kind mentioned in subsection   41MP(2) or 41MPA(2) to the Secretary within the period specified in the regulations; and

  (e)   the person in relation to whom the kind of device is included in the Register will give the manufacturer of the kind of medical device information relevant to:

  (i)   the manufacturer's obligations under the conformity assessment procedures or requirements comparable to those procedures; and

  (ii)   whether medical devices of that kind comply with the essential principles.

  (4)   The regulations may prescribe the amount, standard or kind of information or evidence required for the purposes of paragraphs   (3)(c), (d) and (e).

Advertising material

  (5)   The inclusion of a kind of medical device in the Register is subject to a condition that advertising material relating to medical devices of that kind is consistent with the intended purpose as certified under section   41FD.

Conditions prescribed by the regulations

  (5A)   The inclusion of a kind of medical device in the Register is subject to such conditions (if any) as are prescribed by the regulations.

Conditions determined by the Minister

  (5B)   The inclusion of a kind of medical device in the Register is subject to such conditions (if any) as are determined under subsection   (5C).

  (5C)   The Minister may, by legislative instrument, determine one or more conditions for the purposes of subsection   (5B).

Conditions do not limit other conditions

  (6)   A condition imposed under this section is in addition to any conditions imposed under this Division.