Document ID: chunk:federal_register_of_legislation:C2017A00047:clause:2_41ewa:p1
Version: federal_register_of_legislation:C2017A00047
Segment Type: clause
Provision Reference: sch 2 cl 41EWA (pt 1/2)
Character Range: 7312–10246

41EWA  Conformity assessment body determinations
 (1) The regulations may make provision for and in relation to empowering the Secretary to make conformity assessment body determinations.
 (2) A conformity assessment body determination is a determination that a specified Australian corporation is an Australian conformity assessment body for the purposes of this Act.
 (3) The regulations may make provision for and in relation to the following matters:
 (a) applications for conformity assessment body determinations;
 (b) the approval by the Secretary of a form for such an application;
 (c) information that must accompany such an application;
 (d) the application fee for such an application;
 (e) the lapsing of such an application;
 (f) the assessment by the Secretary of whether a conformity assessment body determination should be made in response to such an application;
 (g) the assessment fee for such an assessment;
 (h) the duration of conformity assessment body determinations.
 (4) A conformity assessment body determination:
 (a) may be of general application; or
 (b) may be limited to either or both of the following:
 (i) one or more specified kinds of medical devices;
 (ii) one or more specified kinds of conformity assessment procedures.
 (5) The regulations may provide that a conformity assessment body determination is subject to:
 (a) the conditions prescribed by the regulations; and
 (b) such other conditions (if any) as are specified in the determination.
 (6) The following are examples of conditions that may be prescribed:
 (a) a condition that the body will allow an authorised person:
 (i) to enter, at any reasonable time, premises used by the body to carry on certification‑related activities; and
 (ii) while on those premises, to inspect those premises and anything on those premises that concerns certification‑related activities carried on by the body; and
 (iii) while on those premises, to make any still or moving image or any recording of those premises or anything on those premises that concerns certification‑related activities carried on by the body; and
 (iv) while on those premises, to inspect, and make copies of, any documents that concern certification‑related activities carried on by the body;
 (b) a condition that the body will, if requested to do so by the Secretary, give the Secretary information, or produce to the Secretary documents, that concern certification‑related activities carried on by the body.
 (7) The regulations may make provision for and in relation to empowering the Secretary to revoke or vary a conformity assessment body determination.
 (8) Subsections (3) to (7) do not limit subsection (1).
 (9) The express references in this section to the Secretary do not, by implication, prevent the regulations from empowering the Secretary to delegate any or all of the Secretary's functions or powers under regulations made for the purposes of this section.